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16 Study Matches
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Boomer, Laura, A
NCT05235165
HM20024392
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Inclusion Criteria:
* Patients must be \< 50 years at the time of enrollment.
* Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size.
* Note: Patient must have eligibility confirmed by rapid central imaging review.
* Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
* Patients must have a histological diagnosis of osteosarcoma.
* Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
* Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
* Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
* Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion Criteria:
* Patients with unresectable primary tumor.
* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
* Patients with evidence of extrapulmonary metastatic disease.
* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Questionnaire Administration, PROCEDURE: Thoracoscopy, PROCEDURE: Thoracotomy
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
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See this study on ClinicalTrials.gov
Show 233 locations
Study Locations
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| Location | Contacts |
|---|---|
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Ann M Wierman MD LTD Las Vegas, Nevada | |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (cancerresearch@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Las Vegas Cancer Center-Henderson Henderson, Nevada | |
| Las Vegas Cancer Center-Medical Center Las Vegas, Nevada | |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | |
| Las Vegas Urology - Green Valley Henderson, Nevada | |
| Las Vegas Urology - Pebble Henderson, Nevada | |
| Las Vegas Urology - Pecos Las Vegas, Nevada | |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | |
| Las Vegas Urology - Sunset Las Vegas, Nevada | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Nicklaus Children's Hospital Miami, Florida | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Northern Nevada Radiation Oncology Reno, Nevada | |
| Northwestern Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| OSF Children's Hospital of Illinois Peoria, Illinois | Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Las Vegas - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oncology Las Vegas - Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Overlake Medical Center Bellevue, Washington | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Radiation Oncology Associates Reno, Nevada | |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (Renown-CRD@renown.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Royal Children's Hospital Parkville, Victoria | |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Starship Children's Hospital Grafton, Auckland | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT MD Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics (STOP PEDS RCT)
Erika Enright - eenright@uw.edu
NCT06654752
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Inclusion Criteria:
• Age
• For main cohort and non-HEMT cohort: age 6 to \<19 years
• For preschool cohort: age 3 to \<6 years
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter
• two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
• Highly Effective Modulator Therapy
• For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment
• For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
• For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
• For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
• Ability to receive text messages and access the internet
Exclusion Criteria:
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
• Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
• Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
• History of solid organ transplant
• History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
• Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
• Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
• Treatment with chronic oral antibiotics other than azithromycin at enrollment
• Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment
OTHER: Immediate Oral Antibiotics, OTHER: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Cystic Fibrosis
cystic fibrosis, oral antibiotics, pulmonary exacerbation, pediatric
I'm interested
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Show 33 locations
Study Locations
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| Location | Contacts |
|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University Chicago, Illinois | Larissa Rugg - (lrugg@luriechildrens.org) |
| Boston Children's Hospital & Harvard University Boston, Massachusetts | Monica Ulles - (monica.ulles@childrens.harvard.edu) |
| British Columbia Children's Hospital Vancouver, British Columbia | Ronak S Ravandi - (ronak.salamatravandi@bcchr.ca) |
| Children's Healthcare of Atlanta & Emory University Atlanta, Georgia | Joy Dangerfield - (jdanger@emory.edu) |
| Children's Hospital of Colorado Aurora, Colorado | Mary Cross - (Mary.Cross@childrenscolorado.org) |
| Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic Los Angeles, California | Jared Lopez, BA - (jalopez@chla.usc.edu) |
| Children's Hospital of Philadelphia & University of Pennsylvania Philadelphia, Pennsylvania | Matthew Gari - (garim@chop.edu) Erin Donnelly - (donnellye4@chop.edu) |
| Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Adrienne DeRicco, RN - (adrienne.dericco2@upmc.edu) |
| Children's Hospitals and Clinics of Minnesota Minneapolis, Minnesota | Danniella Balangoy - (Danniella.Balangoy@childrensmn.org) |
| Children's Mercy Hospital Kansas City, Missouri | Jana Lomonte - (jblomonte@cmh.edu) |
| Children's Wisconsin & Medical College of Wisconsin Milwaukee, Wisconsin | Laura Roth, CCRC - (lroth@mcw.edu) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Sharon Kadon, RN, BSN, CPN - (sharon.kadon@cchmc.org) |
| Johns Hopkins Hospital, Johns Hopkins University Baltimore, Maryland | Jamelia Maynard - (jmaynar8@jhmi.edu) |
| Medical University of South Carolina Charleston, South Carolina | Sarah Shine - (shinesa@musc.edu) |
| Oregon Health & Science University Portland, Oregon | Pierce Nusbaum - (nusbaum@ohsu.edu) |
| Rady Children's Hospital at University of California San Diego San Diego, California | Lisa Ramos, CRC - (lramosvallejo@health.ucsd.edu) |
| Riley Hospital for Children & Indiana University Indianapolis, Indiana | Misty Thompson - (misthomp@iu.edu) Lisa Bendy - (lbendy@iu.edu) |
| Seattle Children's Hospital Seattle, Washington | Alan Genatossio - (alan.genatossio@seattlechildrens.org) Marissa Nelson, CRC - (marissa.nelsen@seattlechildrens.org) |
| St. Louis Children's Hospital & Washington University School of Medicine St Louis, Missouri | Emily Schulte, RN, BSN - (e.burns@wustl.edu) |
| Stanford University Stanford, California | Tina Conti, BSRC, RRT, RRT-NPS, C-NPT - (tconti@stanford.edu) |
| Texas Children's Hospital & Baylor College of Medicine Houston, Texas | Mayel Yepez - (Mayel.YepezDonado@bcm.edu) |
| The Children's Hospital Alabama & University of Alabama at Birmingham Birmingham, Alabama | Valerie Tarn - (vtarn@uabmc.edu) |
| The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics Toronto, Ontario | Claire Crompton - (claire.crompton@sickkids.ca) |
| The Minnesota Cystic Fibrosis Center & University of Minnesota Minneapolis, Minnesota | Alyssa Perry - (ahperry@umn.edu) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth (Lisa) Ryan - (elizabethryan@arizona.edu) |
| University of Iowa Iowa City, Iowa | Mary Teresi - (mary-teresi@uiowa.edu) |
| University of Michigan Health System Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Caroline Flowers, CRC - (caroline_flowers@med.unc.edu) |
| University of Rochester Medical Center Strong Memorial Rochester, New York | Barbara Johnson, RN - (Barbara_johnson@urmc.rochester.edu) |
| University of Texas Southwestern & Children's Health Dallas, Texas | Lindsay Allen, CRC - (Lindsay.Allen@utsouthwestern.edu) |
| University of Wisconsin Madison, Wisconsin | Nikki Cole, BS, RRT, CCRC - (ndondlinger@wisc.edu) |
| Vermont Children's Hospital & University of Vermont Medical Center Burlington, Vermont | Zachary Dichard - (Zachary.Dichard@uvmhealth.org) |
| Virginia Commonwealth University Richmond, Virginia | Aleksander Subotic, CRC - (aleksandar.subotic@vcuhealth.org) |
A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
Olena Boyarska - olena.boyarska@seattlechildrens.org
NCT06504589
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Consent
A. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian
B. Is willing and able to adhere to the study visit schedule and other protocol requirements
Demographics
A. ≥ 12 years of age at Visit 1
Medical History
A. For persons of child-bearing potential: must not be pregnant at Visit 1 or plan to get pregnant during the 12-month study period
Disease History
A. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
* Sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
* Two well-characterized disease-causing pathogenic variants in the CFTR gene
or
* One well-characterized disease-causing mutation and a second CFTR variant (with variable or uncharacterized disease-causing potential) and sweat ≥ 30 mmol/liter with permission of the study sponsor-investigators
B. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1
C. Does not have a history of lung transplantation
Concomitant Medications
A. Not genetically eligible for a CFTR modulator according to product label indications and/or No use of CFTR modulator for 28 days prior to Visit 1 with no intent to start or restart during the study period
B. No use of an investigational drug within 90 days prior to and including Visit 1
C. Not currently participating in an interventional drug or device trial. Participation in long-term safety follow-up studies (without redosing) and/or behavioral intervention trials is allowed.
D. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1
E. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Visit 1
Cystic Fibrosis
ineligible and/or not taking CFTR modulators, People with CF
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Show 68 locations
Study Locations
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| Location | Contacts |
|---|---|
| Adult Cystic Fibrosis Center at the University of Utah Salt Lake City, Utah | Kristyn Packer - (kristyn.packer@hsc.utah.edu) |
| Atrium Health Wake Forest Baptist Winston-Salem, North Carolina | Anna Pippins - (apippins@wakehealth.edu) |
| Augusta University Augusta, Georgia | Heidi Stapp - (hstapp@augusta.edu) |
| Baylor College of Medicine Houston, Texas | Tracy Mosely - (tlmosely@texaschildrens.org) |
| Billings Clinic Billings, Montana | Jerimiah Lysinger - (JLysinger@billingsclinic.org) |
| Boston Children's Hospital Boston, Massachusetts | Robert Fowler - (Robert.fowler@childrens.harvard.edu) |
| Central Florida Pulmonary Group Altamonte Springs, Florida | Desiree Serr - (dserr@cfpulmonary.com) |
| Children's Healthcare of Atlanta and Emory University Atlanta, Georgia | Ashleigh Streby - (ashleigh.streby@emory.edu) |
| Children's Hospital Colorado Aurora, Colorado | Mary Cross - (mary.cross@childrenscolorado.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Erin Donnelly - (Donnellye4@email.chop.edu) |
| Childrens Hospital Los Angeles Los Angeles, California | Carmen Reyes - (mareyes@chla.usc.edu) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Kelly Thornton - (Kelly.Thornton@cchmc.org) |
| Cleveland Clinic Cystic Fibrosis Program Cleveland, Ohio | Dave Weaver - (weaverd@ccf.org) |
| Cohen Children's Medical Center of New York New Hyde, New York | Susan Galvin - (sgalvin@northwell.edu) |
| Columbia University Cystic Fibrosis Program New York, New York | Emily DiMango - (ead3@cumc.columbia.edu) |
| Cook Children's Medical Center Fort Worth, Texas | Anna Reyes - (anna.reyes@cookchildrens.org) |
| Corewell Health Helen DeVos Grand Rapids, Michigan | Alicia Castillo Bahena - (alicia.castillobahena@corewellhealth.org) |
| Dayton Children's Hospital Dayton, Ohio | Amy Jones - (Jonesa11@childrensdayton.org) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Kristina "Tina" Adrean - (Kadrean@ascension.org) |
| Hershey Medical Center Pennsylvania State University Hershey, Pennsylvania | Diane M Kitch - (dkitch@pennstatehealth.psu.edu) |
| Inova L.J. Murphy Pediatric CF Program Fairfax, Virginia | Colleen Mann - (colleen.mann@inova.org) |
| John Hopkins Hospital Baltimore, Maryland | Jeanne Pinto - (jpinto4@jh.edu) |
| Massachusetts General Hospital Lexington, Massachusetts | Margot Hardcastle - (mhardcastle@mgh.harvard.edu) |
| Medical University of South Carolina Charleston, South Carolina | Ashley Warden - (jonesash@musc.edu) |
| Morristown Medical Center Morristown, New Jersey | Debra Connolly - (Debra.Connolly@atlantichealth.org) |
| National Jewish Health Denver, Colorado | Alix Wilson - (wilsona@njhealth.org) |
| Nationwide Children's Hospital Columbus, Ohio | Diana Gilmore - (Diana.Gilmore@nationwidechildrens.org) |
| New York Medical College at Westchester Medical Center Valhalla, New York | Zachary Messer - (Zachary_Messer@nymc.edu) |
| Northwestern University Chicago, Illinois | Rachel Nelson - (rachel.nelson@northwestern.edu) |
| Oregon Health & Sciences University Portland, Oregon | Jenna Bucher - (bucherj@ohsu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | Natalia Argel - (Nargel@phoenixchildrens.com) |
| Prisma Health Children's Hospital - Midlands Columbia, South Carolina | Veronica Lipscomb - (Veronica.Lipscomb@PrismaHealth.org) |
| Providence Medical Group, Cystic Fibrosis Clinic Spokane, Washington | Joan Milton - (joan.milton@providence.org) |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland, Ohio | Primary RC & Participant Contact General Contact - (RainbowCFResearch@UHhospitals.org) |
| Riley Hospital for Children Indianapolis, Indiana | Lisa Bendy - (lbendy@iupui.edu) |
| Saint Luke's Cystic Fibrosis Center of Idaho Boise, Idaho | Lejla Godusevic - (godusevl@slhs.org) |
| Seattle Children's Hospital Seattle, Washington | Sharon McNamara - (sharon.mcnamara@seattlechildrens.org) |
| Stanford University Medical Center Palo Alto, California | Jacquelyn Spano - (jmzirbes@stanford.edu) |
| Tampa General Hospital Tampa, Florida | Andrew Marino - (armarino@usf.edu) |
| The Children's Hospital Alabama, University of Alabama at Birmingham Birmingham, Alabama | Kathryn Monroe - (kathrynmonroe@uabmc.edu) |
| The Cystic Fibrosis Center of Western New York Buffalo, New York | Julianne Hergenroder - (jhergenroder@upa.chob.edu) |
| The Minnesota Cystic Fibrosis Center Minneapolis, Minnesota | CF Trials Contact University of Minnesota, Participant Contact - (cftrials@umn.edu) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth Ryan - (elizabethryan@email.arizona.edu) |
| Tulane University New Orleans, Louisiana | Adrienne Savant - (asavant1@tulane.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | Kathleen Hicks - (HicksKathleenT@uams.edu) |
| University of California San Diego La Jolla, California | Jenna Mielke - (jmielke@health.ucsd.edu) |
| University of California, San Francisco - Adult Center San Francisco, California | Courtney Moreno - (Courtney.Moreno@ucsf.edu) |
| University of California, San Francisco - Peds Center San Francisco, California | Ngoc Ly - (Ngoc.Ly@ucsf.edu) |
| University of Florida Gainesville, Florida | Chrystal Bailey - (Cbailey1@peds.ufl.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Lawrence Scott - (lscott2@kumc.edu) |
| University of Kentucky Lexington, Kentucky | Chase Whitaker - (chase.whitaker@uky.edu) |
| University of Massachusetts Memorial Health Care Worcester, Massachusetts | Jaclyn Longtine - (Jaclyn.Longtine@umassmed.edu) |
| University of Miami Miami, Florida | Ylber (Ivan) Whitaker - (yiw2@miami.edu) |
| University of Michigan, Michigan Medicine Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Michel Veit - (michel.veit@unmc.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Julie Goudy - (julie_goudy@med.unc.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Melissa Molter - (melissa.molter@pennmedicine.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Adrienne DeRicco - (adrienne.dericco2@upmc.edu) |
| University of Rochester Medical Center Strong Memorial Rochester, New York | Barb Johnson - (Barbara_Johnson@URMC.Rochester.edu) |
| University of Texas Southwestern Dallas, Texas | Ashley Keller - (Ashley.Keller@UTSouthwestern.edu) |
| University of Texas Southwestern / Children's Health Dallas, Texas | Keianna Brown - (Keianna.brown@utsouthwestern.edu) |
| University of Washington Medical Center Seattle, Washington | Lauren Bartlett - (lrejman@uw.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson - (mnelson@pediatrics.wisc.edu) |
| Vanderbilt University Medical Center Nashville, Tennessee | Brijesh Patel - (brijesh.patel@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis - (akilah.pierrelouis1@vcuhealth.org) |
| Washington University School of Medicine St Louis, Missouri | Irma Bauer - (irmabauer@wustl.edu) |
| Wayne State University Harper University Hospital Detroit, Michigan | Debra Driscoll - (ddriscol@med.wayne.edu) |
| West Virginia University - Morgantown Morgantown, West Virginia | Tammy Clark - (tclark@hsc.wvu.edu) |
Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06731413
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Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
* Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
* No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
* Age 70 or meeting frailty definition or above at the date of signing informed consent
* Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)
* PD-L1 tumor proportion score (TPS) of less than 50%
* Eastern Cooperative Oncology Group (ECOG) PS of 0-3
* Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment
* Absolute neutrophil count (ANC) ≥ 1,000/μL
* Platelets ≥ 75,000/μL
* Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion permitted)
* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
* Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Participants with life expectancy of less than 3 months at the time of enrollment
* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
* Diagnosis of interstitial lung disease
* Creatinine clearance of \<30 mL/min
* Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
* Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:
* Doses less than or equal to the equivalent of prednisone 10 mg daily
* Short courses of steroids that are discontinued prior to enrollment
* Inhaled, intranasal and/or topical steroids
* Dexamethasone taper for treating vasogenic edema associated with CNS disease DRUG: Reduced Dose of Chemotherapy and Immunotherapy
Non-small Cell Lung Cancer, NSCLC, Advanced Non-small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer, NSCLC
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Study Locations
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| Location | Contacts |
|---|---|
| VCU Health Tappahannock Hospital Tappahannock, Virginia | Massey CTO Lung Team - (masseylung@vcu.edu) |
| Virginia Commonwealth University Richmond, Virginia | Massey Lung Team - (masseylung@vcu.edu) |
Health Education Approach to Lung Screening (HEALS)
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06070870
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Inclusion Criteria:
* Meets current USPSTF guidelines for lung cancer screening (LCS)
* 20 pack-year smoking history Note: A pack-year is a way of calculating how much a person has smoked in their lifetime.
One pack-year is the equivalent of smoking an average of 20 cigarettes-1 pack-per day for a year.
* Currently smokes or has quit smoking within the past 15 years
* Identifies as Black or African-American Note: Both Hispanic/Latino and Non-Hispanic/Latino patients are eligible as long as they also identify as Black or African-American (eg, Afro-Latino).
* Willing to complete all navigation-related study activities
* Able to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
A patient who meets any of the following exclusion criteria is ineligible to participate in the study:
* Known history of cancer (except squamous cell skin cancer), or coughing up blood in the past 5 years, as reported by the individual
* Has undergone a previous lung cancer screening
* Inability to speak English
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements BEHAVIORAL: Patient Navigation
Lung Cancer
Lung cancer, Screening
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Study Locations
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| Location | Contacts |
|---|---|
| Medical University of South Carolina Charleston, South Carolina | Megan Ellison, Ed.D - (ellisome@musc.edu) |
| University of North Carolina-Chapel Hill Carrboro, North Carolina | Christopher Lyu, MPA - (Christopher_Lyu@med.unc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Massey CPC Team - (MasseyCPC@vcu.edu) |
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study (STOP360AG)
Rachael Buckingham, BS - Rachael.buckingham@seattlechildrens.org
NCT05548283
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Inclusion Criteria:
* All genders ≥ 6 years of age at Visit 1
* Documentation of a CF diagnosis
* Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials
* At least one documented Pa positive culture within two years prior to Visit 1
Exclusion Criteria:
* Participant is not pregnant
* No known renal impairment or history of solid organ transplantation
* No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1
* No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1
* No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
* No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1 DRUG: Beta-lactam antibiotic, DRUG: Aminoglycoside
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Cystic Fibrosis, CF, Cystic Fibrosis Pulmonary Exacerbation, aminoglycoside, beta-lactam, β-lactam, STOP, STOP360
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Show 60 locations
Study Locations
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| Location | Contacts |
|---|---|
| All Children's Hospital St. Petersburg, Florida | Diana Hodge - (dhodge6@jhmi.edu) |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Yung Hsuan (Irene) Wu - (yhwu@luriechildrens.org) |
| Billings Clinic Billings, Montana | Jerimiah Lysinger - (JLysinger@billingsclinic.org) |
| Boston Children's Hospital, Brigham & Women's Hospital Boston, Massachusetts | Robert Fowler - (Robert.fowler@childrens.harvard.edu) |
| CHOC Children's Hospital Orange, California | Lila Klein - (Lila.klein@choc.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | Michelle Parrish - (MParrish@akronchildrens.org) |
| Children's Hospital of New York New York, New York | Hossein Sadeghi - (HS762@cumc.Columbia.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Elizabeth Hartigan - (elizabeth.hartigan@chp.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Jack Serio - (jserio@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Kelly Thornton - (Kelly.Thornton@cchmc.org) |
| Cook Children's Medical Center Fort Worth, Texas | Jill Finto - (jill.finto@cookchildrens.org) |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | Barbara A Rodgers - (Barbara.A.Rodgers@hitchcock.org) |
| Dayton Children's Hospital Dayton, Ohio | Amy Jones - (Jonesa11@childrensdayton.org) |
| Emory University Atlanta, Georgia | Ashleigh Streby - (ashleigh.streby@emory.edu) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Andrew James - (andrew.james@corewellhealth.org) |
| Indiana University Medical Center Indianapolis, Indiana | Lisa Bendy - (lbendy@iu.edu) |
| Joe DiMaggio Children's Hospital Hollywood, Florida | Norma (Jean) Barton - (nbarton@mhs.net) |
| John Hopkins Hospital Baltimore, Maryland | Jeanne Pinto - (jpinto4@jh.edu) |
| Lenox Hill Hospital Cystic Fibrosis Center New York, New York | Teresa Demarco - (Tdemarco3@northwell.edu) |
| Long Beach Memorial Medical Center Long Beach, California | Marylee Melendrez - (mmelendrez@memorialcare.org) |
| Maine Medical Center Scarborough, Maine | Harmony Renna - (Harmony.Renna@mainehealth.org) |
| Medical University of South Carolina Charleston, South Carolina | Ashley Warden - (jonesash@musc.edu) |
| Morristown Medical Center Morristown, New Jersey | Debra Connolly - (Debra.Connolly@atlantichealth.org) |
| Nationwide Children's Hospital Columbus, Ohio | Diana Gilmore - (Diana.Gilmore@nationwidechildrens.org) |
| Nemours Children's Clinic Jacksonville, Florida | Jennifer (Jenn) Gafford - (Jennifer.gafford@nemours.org) |
| New York Medical College at Westchester Medical Center Valhalla, New York | Zachary Messer - (Zachary_Messer@nymc.edu) |
| Northwestern University Chicago, Illinois | Rachel Nelson - (rachel.nelson@northwestern.edu) |
| OSF Saint Francis Medical Center Peoria, Illinois | Ashley Scott - (Ashley.Scott@osfhealthcare.org) |
| Oklahoma Cystic Fibrosis Center Oklahoma City, Oklahoma | CF Center Participant Contact - (cfresearchteam@ouhsc.edu) |
| Oregon Health Sciences University Portland, Oregon | Jenna Bucher - (bucherj@ohsu.edu) |
| Providence Medical Group, Cystic Fibrosis Clinic Spokane, Washington | Joan Milton - (joan.milton@providence.org) |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland, Ohio | Primary RC & Participant Contact General Contact - (RainbowCFResearch@UHhospitals.org) |
| Riley Hospital for Children Indianapolis, Indiana | Lisa Bendy - (lbendy@iupui.edu) |
| Rutgers - Robert Wood Johnson Medical School New Brunswick, New Jersey | Sheila Redding, Sheila - (sr1238@rwjms.rutgers.edu) |
| SSM Health Cardinal Glennon Children's Hospital St Louis, Missouri | Freda Branch - (freda.branch@health.slu.edu) |
| Saint Luke's Cystic Fibrosis Center of Idaho Boise, Idaho | Lejla Godusevic - (godusevl@slhs.org) |
| Seattle Children's Hospital Seattle, Washington | Sharon McNamara - (sharon.mcnamara@seattlechildrens.org) |
| The Children's Hospital Alabama, University of Alabama at Birmingham Birmingham, Alabama | Heather Hathorne - (hyhathorne@uabmc.edu) |
| Toledo Children's Hospital Toledo, Ohio | Kelly Hoot - (kelly.hoot@promedica.org) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth Ryan - (elizabethryan@email.arizona.edu) |
| University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB) Calgary, Alberta | Clare Smith - (Clare.smith@albertahealthservices.ca) |
| University of California San Diego La Jolla, California | Jenna Mielke, - (jmielke@health.ucsd.edu) |
| University of California at Davis Medical Center Sacramento, California | Daniel Diaz-Vigil - (ddiazvigil@ucdavis.edu) |
| University of Cincinnati Medical Center Cincinnati, Ohio | Nicole Hummel - (Nicole.Hummel@UCHealth.com) |
| University of Florida Gainesville, Florida | Melissa Lingis - (melissa.lingis@peds.ufl.edu) |
| University of Iowa Iowa City, Iowa | Mary Teresi - (mary-teresi@uiowa.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Lawrence Scott - (lscott2@kumc.edu) |
| University of Louisville Louisville, Kentucky | Melissa Thomas - (mcthom12@louisville.edu) |
| University of Massachusetts Memorial Health Care Worcester, Massachusetts | Jaclyn Longtine - (Jaclyn.Longtine@umassmed.edu) |
| University of Miami Miami, Florida | Ylber Whitaker - (yiw2@miami.edu) |
| University of Michigan, Michigan Medicine Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Melissa Molter - (melissa.molter@pennmedicine.upenn.edu) |
| University of Texas Southwestern Dallas, Texas | Ashley Keller - (Ashley.Keller@UTSouthwestern.edu) |
| University of Texas Southwestern / Children's Health Dallas, Texas | Mary Klosterman - (Mary.Klosterman@UTSouthwestern.edu) |
| University of Washington Medical Center Seattle, Washington | Lauren Bartlett - (lrejman@uw.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson - (mnelson@pediatrics.wisc.edu) |
| Vanderbilt Children's Hospital Nashville, Tennessee | Brijesh Patel - (brijesh.patel@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis - (akilah.pierrelouis1@vcuhealth.org) |
| Washington University School of Medicine St Louis, Missouri | Irma Bauer - (irmabauer@wustl.edu) |
| West Virginia University - Morgantown Morgantown, West Virginia | Tammy Clark - (tclark@hsc.wvu.edu) |
Pulmonary Hypertension Association Registry (PHAR)
Elizabeth Joseloff, PhD - PHAR@PHAssociation.org
NCT04071327
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Inclusion Criteria:
* All age groups
* Written informed consent
* Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease
* Within 6 months of first outpatient visit at a PH Care Center
Exclusion Criteria:
* Diagnosis of WSPH Group 2 pulmonary hypertension
* Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease
* Diagnosis of WSPH Group 5 pulmonary hypertension Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
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Study Locations
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| Location | Contacts |
|---|---|
| Allegheny General Hospital Pittsburgh, Pennsylvania | Amresh Raina, MD - (amresh.raina@ahn.org) Kimberly Curry, RN - (kimberly.curry@ahn.org) |
| AnMed Health Anderson, South Carolina | Abhijit Raval, MD - (drravallung@gmail.com) Kelly Dickson, RRT - (kelly.dickson@anmedhealth.org) |
| Arizona Pulmonary Specialists, Ltd. Phoenix, Arizona | |
| Aurora St. Luke's Medical Center Milwaukee, Wisconsin | Michelle Cicona - (michelle.cicona@aurora.org) |
| Baylor Scott & White Plano, Texas | Sahil Bakshi, MD - (sahil.bakshi@bswhealth.org) Lucy Knight - (lucy.knight@bswhealth.org) |
| Children's Hospital Colorado Aurora, Colorado | Dunbar Ivy, MD - (dunbar.ivy@childrenscolorado.org) Kathleen Miller-Reed - (kathleen.miller-reed@childrenscolorado.org) |
| Cincinnati Children's Hospital Cincinnati, Ohio | Russel Hirsch, MD - (russel.hirsch@cchmc.org) Alyssa Rhode, BS - (alyssa.rhode@cchmc.org) |
| Columbia University Medical Center/NewYork-Presbyterian Hospital New York, New York | Erika S. Berman Rosenzweig, MD - (esb14@cumc.columbia.edu) Daniela Brady, FNP - (dm2069@cumc.columbia.edu) |
| Cottage Health System - Santa Barbara Pulmonary Associates Santa Barbara, California | Jeffrey S. Sager, MD, MS - (jsager@sblung.com) Caitlin Torchia, RN - (ctorchia@sbch.org) |
| Duke University Medical Center Durham, North Carolina | Kishan Parikh, MD - (kishan.parikh@duke.edu) Noely Martinez-Overby, CMA - (noely.martinez-overby@duke.edu) |
| Froedtert & Medical College of Wisconsin Milwaukee, Wisconsin | Kenneth W. Presberg, MD - (kpresber@mcw.edu) Amy Kimber, APNP - (akimber@mcw.edu) |
| Ft. Sanders Regional Medical Center Knoxville, Tennessee | Regina Overton-Barnes, APN - (rbarnes@statcaremed.net) |
| Henry Ford Hospital Detroit, Michigan | Rana L. Awdish, MD - (rawdish1@hfhs.org) Sheri Renaud, RN - (srenaud9@hfhs.org) |
| Indiana University Health Indianapolis, Indiana | Michael Duncan, MD - (mduncan3@iuhealth.org) Melissa Astin, BSN - (mastin@iuhealth.org) |
| Inova Fairfax Hospital Falls Church, Virginia | Oksana A. Shlobin, MD - (oksana.shlobin@inova.org) Edwinia Battle, BSN, CCRC - (edwinia.battle@inova.org) |
| Johns Hopkins University Baltimore, Maryland | Stephen C. Mathai, MD, MHS - (smathai4@jhmi.edu) Julie Shamberger, RN - (jshambe2@jhmi.edu) |
| KU Medical Center Kansas City, Kansas | Timothy Williamson, MD - (twillia1@kumc.edu) |
| Kentuckiana Pulmonary Associates Louisville, Kentucky | |
| LSU Healthcare Network Clinic New Orleans, Louisiana | Matthew Lammi, MD - (mlammi@lsuhsc.edu) Paula Lauto, RN - (plauto@lsuhsc.edu) |
| Mayo Clinic Rochester, Minnesota | Robert P. Frantz, MD - (frantz.robert@mayo.edu) |
| Mayo Clinic Florida Jacksonville, Florida | Charles D. Burger - (burger.charles@mayo.edu) Kristine Gundian, CRC - (gundian.kristine@mayo.edu) |
| Northside Hospital Atlanta, Georgia | Paul Boyce, MD, MPH - (paul.boyce@northside.com) Tamara Wakhisi - (tamara.wakhisi@northside.com) |
| Ochsner Medical Center New Orleans, Louisiana | Stacy Mandras, MD - (smandras@ochsner.org) Angela Penning - (angela.penning@ochsner.org) |
| Rhode Island Hospital Providence, Rhode Island | Corey E. Ventetuolo, MD, MS - (corey_ventetuolo@brown.edu) Amy Palmisciano, BSN - (apalmisciano@lifespan.org) |
| Seattle Children's Hospital Seattle, Washington | Delphine Yung, MD - (delphine.yung@seattlechildrens.org) Anne Davis, RN - (anne.davis@seattlechildrens.org) |
| Sentara Heart Hospital Norfolk, Virginia | Melinda Bullivant, MSN, RN, CCRC - (mmbulliv@sentara.com) |
| Stanford University Stanford, California | Doris Stanley, BS - (dstandley@stanford.edu) Patricia Del Rosario, RN - (pdelrosa@stanford.edu) |
| Texas Children's Hospital Houston, Texas | Nidhy Varghese, MD - (npvarghe@texaschildrens.com) Elise Whalen, MSN - (ecbockov@texaschildrens.com) |
| The Oregon Clinic Portland, Oregon | Jeffrey C. Robinson, MD - (jerobinson@orclinic.com) Stephanie Persons, BS - (spersons@orclinic.com) |
| UC Davis Health Sacramento, California | Nikhil Jaha - (nkjaha@ucdavis.edu) Cynthia Perry-Baker - (clpbaker@ucdavis.edu) |
| UC Health Cincinnati, Ohio | Jean M. Elwing, MD - (elwingj@ucmail.uc.edu) Jennifer Gilkison, RN, BSN - (gilkisjr@ucmail.uc.edu) |
| UC Health - Anschutz Medical Campus Aurora, Colorado | David Badesch, MD - (david.badesch@cuanschutz.edu) Kelly Hannon, RN - (kelly.hannon@cuanschutz.edu) |
| UCSF Benioff Children's Hospital San Francisco, California | Jeffrey Fineman, MD - (jeff.fineman@ucsf.edu) Jasmine Becerra - (jasmine.becerra@ucsf.edu) |
| UCSF Medical Center San Francisco, California | Teresa De Marco, MD - (teresa.demarco@ucsf.edu) Amanda Schnell Heringer, RN, CNS - (amanda.schnellheringer@ucsf.edu) |
| UNC Chapel Hill Chapel Hill, North Carolina | H. James Ford, MD - (hjford@med.unc.edu) Laura Nowicki, RN - (laura_nowicki@med.unc.edu) |
| UT Southwestern Medical Center Dallas, Texas | Sonja D. Bartolome, MD - (sonja.bartolome@utsouthwestern.edu) Balaji Kolasani - (balaji.kolasani@utsouthwestern.edu) |
| University of Connecticut Health Farmington, Connecticut | Raymond Foley, DO - (r.foley@uchc.edu) |
| University of Iowa Hospitals & Clinic Iowa City, Iowa | |
| University of MD Medical Group, PA Baltimore, Maryland | Gautam V. Ramani, MD - (gramani@som.umaryland.edu) Lioubov Poliokova - (lpoliako@som.umaryland.edu) |
| University of Minnesota Health Minneapolis, Minnesota | Thenappan Thenappan, MD - (tthenapp@umn.edu) Gretchen Piechel - (gpeichel@umn.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Steven M. Kawut, MD, MS - (kawut@upenn.edu) Randi Goodman - (randi.goodman@pennmedicine.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Marc A. Simon, MD, MS - (simonma@upmc.edu) Abby Sung - (sunga3@upmc.edu) |
| University of Rochester Medical Center Rochester, New York | R. James White, MD, PhD - (jim_white@urmc.rochester.edu) Allison Light-Mills, PhD - (allison_light@urmc.rochester.edu) |
| University of Utah Health Salt Lake City, Utah | John J. Ryan, MD - (john.ryan@hsc.utah.edu) Brittany Penn - (brittany.penn@hsc.utah.edu) |
| University of Virginia Charlottesville, Virginia | Sula Mazimba, MD - (sm8sd@hscmail.mcc.virginia.edu) Allison Raymond, RN, CCRC - (AEH4M@hscmail.mcc.virginia.edu) |
| University of Washington Seattle, Washington | Peter Leary, MD, PhD - (learyp@uw.edu) Genecelle Delossantos - (gen7@medicine.washington.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | James R. Runo, MD - (jrr@medicine.wisc.edu) Amy Chybowski, NP - (amy.chybowski@uwmf.wisc.edu) |
| VCU Medical Center Richmond, Virginia | Daniel Grinnan, MD - (daniel.grinnan@vcuhealth.org) Charnetta Lester - (charnetta.robinson@vcuhealth.org) |
| Vanderbilt Children's Hospital Nashville, Tennessee | Eric D. Austin, MD, MSc - (eric.austin@vumc.org) Karen Chaffin, NP - (karen.e.chaffin@vumc.org) |
| Vanderbilt University Medical Center Nashville, Tennessee | Anna R. Hemnes, MD - (anna.r.hemnes@vumc.org) |
| Washington University in St. Louis St Louis, Missouri | Murali M. Chakinala, MD - (chakinalam@wustl.edu) Ellen Newton-Lovato, RN - (elovato@wustl.edu) |
| Weill Cornell Medical Center New York, New York | Evelyn M. Horn, MD - (horneve@med.cornell.edu) Rosemarie Gadioma - (gadioma@nyp.org) |
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial (DIVA)
Elizabeth Foglia - FOGLIA@email.chop.edu
NCT05446272
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Inclusion Criteria:
* Gestational age of 23 0/7- 28 6/7 weeks at birth
* Intubated in the first 7 days of life
* Undergoing extubation following at least 12 hours of invasive mechanical ventilation
* Post-natal age \<32 weeks Post menstrual age at time of extubation
Exclusion Criteria:
* Major congenital anomalies, including pulmonary hypoplasia
* Neurologic disorders affecting respiratory drive (other than apnea of prematurity)
* Esophageal bleeding or other contraindication to NG/OG catheter placement
* Current weight \<500 grams (based on Edi catheter approval)
* Study ventilator not available at time eligibility criteria are met
* Planned surgery or invasive procedure within 5 days of extubation
* Informed consent not provided DEVICE: NIV-NAVA, DEVICE: NS-NIPPV
Extubation Failure, Bronchopulmonary Dysplasia, Death
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Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando, Florida | Samarth Shukla - (Samarth.Shukla.MD@AdventHealth.com) |
| Arkansas Children's Hospital Little Rock, Arkansas | David Matlock - (DMatlock@uams.edu) |
| Atrial Health Brenner Children's Hospital( Wake Forest) Winston-Salem, North Carolina | Ricardo J Rodriguez - (rjrodrig@wakehealth.edu) |
| BC Children's and Women's Hospital Vancouver, | Jonathan Wong - (jonathan.wong@cw.bc.ca) |
| Children's Hospital of Richmond Richmond, Virginia | Karen Hendrick-Munoz - (karen.hendricks-munoz@vcuhealth.org) |
| Children's Mercy Hospital Kansas City, Missouri | Christopher Nitkin - (crnitkin@cmh.edu) |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | Elizabeth Foglia - (FOGLIA@email.chop.edu) |
| Intermountain Medical Center Murray, Utah | Bradley Yoder - (Bradley.Yoder@hsc.utah.edu) |
| Joe DiMaggio Children's Hospital Hollywood, Florida | Bruce Shulman - (brucesmd@icloud.com) |
| Levine Children's Hospital Charlotte, North Carolina | Eugenia Pallotto - (Eugenia.Pallotto@atriumhealth.org) |
| Loma Linda University San Bernardino, California | |
| Mt Sinai Hospital Toronto, | Amish Jain - (Amish.Jain@sinaihealth.ca) |
| Nationwide Children's Hospital Columbus, Ohio | - (Matthew.Kielt@nationwidechildrens.org) |
| Norton Children's Hospital Louisville, Kentucky | Dan Stewart - (dan.stewart@louisville.edu) |
| Peyton Manning Children's Hospital Indianapolis, Indiana | Markus Tauscher - (mktausc1@ascension.org) |
| Sharp Mary Birch San Diego, California | Anup Katheria - (Anup.Katheria@sharp.com) |
| Sunnybrook Health Sciences Centre Toronto, Ontario | Maher Shahroor - (maher.shahroor@sunnybrook.ca) |
| Utah Valley Hospital Provo, Utah | - (Bradley.Yoder@hsc.utah.edu) |
| Virtua Vorhees Hospital Voorhees Township, New Jersey | - (ghavams@chop.edu) |
| Washington University in St.Louis St Louis, Missouri | - (rao_r@wustl.edu) |
Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases
Ryan Gentzler, MD, MS - rg2uc@uvahealth.org
NCT06248606
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Inclusion Criteria:
• Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0-1 within 28 days prior to registration.
• Confirmation of stage IV non-small cell lung cancer (NSCLC) per AJCC, 8th edition, or metastatic recurrence after treatment for earlier stage disease.
• Known to have a KRAS G12C mutation. KRAS G12C mutation can be determined based on local tissue and/or ctDNA testing.
• Presence of brain metastases that meet the following criteria: * Patients must have at least 1 untreated enhancing intracranial lesion, per local radiology interpretation, measuring at least 2mm. NOTE: intracranial lesions do not need to be measurable by RECIST 1.1 criteria to be eligible. * Must have no single metastasis measuring larger than 3 cm. * Patients with surgically resected brain metastases are eligible provided there are additional brain metastases amenable to SRS * Patients with progression of previously radiated or surgically resected CNS metastases are eligible if solid component of lesion has enlarged and there is no concern for radionecrosis based on investigator discretion. * Patients who received SRS within 4 weeks prior to registration are eligible provided baseline brain MRI prior to SRS treatment is within 4 weeks of study registration and SRS treatment meets requirements in #7 below. * Symptomatic brain metastases are permitted if the following criteria are met: * No evidence of cerebral herniation or symptomatic leptomeningeal disease * No seizures within past 14 days; antiepileptic medications are permitted * Patients on steroids must have stable or improving neurologic symptoms that have not worsened during a steroid taper. Must be receiving the equivalent of dexamethasone 8 mg total daily dose or less at the time of registration.
• CNS lesions have already been treated with SRS (within 3 weeks prior to Cycle 1 Day 1) or are amenable to SRS as determined by radiation oncologist and/or neurosurgeon. SRS treatment must use GammaKnife or linear accelerator-based treatments with nominal x-ray energy of 6MV or greater.
• No contraindications to SRS. Patients on anticoagulation must be able to hold anticoagulation for SRS treatment based on investigator discretion.
• Patients may be treatment-naïve OR have received up to 2 prior lines of systemic therapy. Treatment with systemic therapy for Stage I-III disease \> 12 months prior to development of metastases do not count as a line of therapy. Treatment with platinum-doublet chemotherapy and checkpoint inhibitor immunotherapy (PD-1, PD-L1, CTLA-4, etc.) either in combination or sequentially counts as one line of therapy.
• Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration. * Hemoglobin (Hgb): ≥ 8.0 g/dL in the absence of transfusions within 7 days prior to testing. * Calculated creatinine clearance: ≥ 60 mL/min * Bilirubin: ≤ 1.5 mg/dL * Aspartate aminotransferase (AST): ≤ 3.0 × ULN * Alanine aminotransferase (ALT): ≤ 3.0 × ULN
• Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment initiation.
• Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception. Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception.
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. Testing is not required at screening unless mandated by local policy.
• Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy.
• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Exclusion Criteria:
• Prior treatment with KRAS G12C tyrosine kinase inhibitor.
• Active infection requiring systemic therapy with the exception of #13 and #14 above.
• Uncontrolled, significant intercurrent or recent illness.
• Prolonged QTc interval \> 480 milliseconds or history of congenital Long QT Syndrome
• Currently receiving radiation treatment at the time of enrollment to any extra-cranial lesion for prophylaxis or pain control. Patients may enroll after completion of palliative RT.
• Ongoing need for treatment with concomitant medication known as a strong inhibitor or inducer of CYP3A enzyme and that cannot be switched to an alternative treatment prior to study enrollment. NOTE: Discontinuation of CYP3A4 inducers should occur a minimum of 7 days or 5 times their half-life, whichever is longer, prior to C1D1 study treatment.
• Treatment with any investigational drug within 28 days prior to registration.
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
DRUG: Adagrasib, RADIATION: Stereotactic Radiosurgery
Non Small Cell Lung Cancer, NSCLC, KRAS G12C
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| Location | Contacts |
|---|---|
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Sarah Jewell - (sarah.jewell@osumc.edu) |
| University of Virginia Health System Charlottesville, Virginia | Gracie Hockenberry, RN - (mgt4n@virginia.edu) |
| Virginia Commonwealth University Richmond, Virginia | Nicole Knight - (nknight@vcu.edu) |
Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer (CURB2)
Pierre-Olivier Gaudreau - p-ogaudreau@ctg.queensu.ca
NCT06686771
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Inclusion Criteria:
* Metastatic disease (stage IV) detected on imaging and histologically and/or cytologically confirmed NSCLC as per the WHO Classification of Tumors and AJCC 8th Edition TNM Classification, without a driver mutation with an actionable first-line targeted therapy, for whom either ICI alone or combination ICI + chemotherapy is indicated
* Oligoprogression on first-line ICI +/- chemotherapy systemic therapy after at least 3 cycles.
* All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy as determined by radiation treatment preplan, including availability and tolerability of necessary technologies (e.g., active breathing control, MRLinac, fiducial insertion, etc.) and accounting for previous radiotherapy overlap. Safety must be assessed and determined by a radiation oncologist.
* Patients with treated CNS disease who have radiologic and clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).
* Candidate for regulatory approved SOC first-line orsecond-line systemic therapy options.
* Participants must be ≥ 18 years of age.
* ECOG performance status of 0, 1 or 2.
* Participants that received prior adjuvant/neoadjuvant/consolidation systemic therapy (including chemotherapy and ICI ) are eligible if at least 6 months have elapsed between the completion of prior therapy and start of first-line treatment for metastatic disease.
* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic therapy. If participants experienced prior immune-mediated toxicity and have not yet re-initiated ICI therapy, please contact CCTG. Please also contact CCTG if participants have ongoing toxicity ≥ grade 1 felt to be clinically insignificant.
* Previous surgery related to NSCLC in the curative or metastatic disease setting is permitted. Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred.
* Prior external beam radiation related to NSCLC in the metastatic disease setting is permitted provided a minimum of 14 days (2 weeks) have elapsed between the last dose of radiation and date of enrollment. Patients that received prior external beam radiation therapy in the NSCLC curative disease setting (including the primary lesion) are eligible. Oligoprogressive lesions previously treated with external beam radiation are eligible as long they are clinically asymptomatic, and re-treatment is possible according to the investigator.
* Prior conventional, non-stereotactic radiotherapy for palliative purposes is allowed, and if the palliated lesion subsequently progressed but asymptomatic not requiring immediate RT, the lesion can still be counted toward one of the five oligoprogressive lesions.
* For Arm 1, SBRT must be initiated within 3 weeks of participant enrollment.
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French, or Spanish.
* Reimbursement of continued SOC ICI and chemotherapy systemic therapies may not be uniform across all sites. In the event that site/investigator is unable to provide access to the drug, participant will not be eligible for this trial.
* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
Exclusion Criteria:
* Large-cell neuroendocrine carcinoma (LCNEC), pulmonary carcinoid tumour or mixed small cell and non-small cell lung cancer are not eligible.
* Presence of leptomeningeal disease.
* Pregnancy.
* Serious medical conditions in which radiotherapy of target lesions is contraindicated (e.g., scleroderma, Ataxia Telangiectasia (ATM), interstitial lung disease (ILD), Child-Pugh C liver function).
* Any other condition in which in the judgement of the investigator would make the patient inappropriate for study entry.
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Concomitant medications should only exclude participants from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy; please consult the relevant product monographies.
* Concurrent treatment with other anti-cancer therapy, including investigational agents.
* Live attenuated vaccination administered within 30 days prior to enrollment/randomization. RADIATION: SBRT, OTHER: First or second-line standard of care therapy
Non-small Cell Lung Cancer
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Study Locations
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| Location | Contacts |
|---|---|
| Alton Memorial Hospital Alton, Illinois | |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Cross Cancer Institute Edmonton, Alberta | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Lenox Hill Hospital New York, New York | |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai West New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Queens Cancer Center Rego Park, New York | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado | Site Public Contact - (ccrp@co-cancerresearch.org) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Pella Pella, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
United Therapeutics Global Medical Information - clinicaltrials@unither.com
NCT06388421
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Inclusion Criteria:
• Adults aged 18 years or older
• Diagnosis of fibrotic ILD based on high-resolution computed tomography imaging, including but not limited to:
• Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
• Autoimmune ILD
• Chronic hypersensitivity pneumonitis
• Nonspecific interstitial pneumonia
• Occupational lung disease
• Combined pulmonary fibrosis and emphysema with fibrosis greater than the extent of emphysema on lung imaging as determined by the Investigator
• For patients to be eligible for Cohorts 1 to 3: RHC confirmed PH (mean pulmonary artery pressure \>20 mmHg, pulmonary artery wedge pressure ≤15 mmHg, pulmonary vascular resistance \>2 WU).
• For patients to be eligible for Cohort 1, they must not be receiving inhaled treprostinil at Baseline.
• For patients to be eligible for Cohort 2, they must have initiated Tyvaso/Tyvaso DPI at 1 of the following time points:
• Baseline
• ≤90 days prior to Baseline 6. For patients to be eligible for Cohort 3, they must be receiving Tyvaso/Tyvaso DPI at Baseline and for \>90 days prior to Baseline. 7. For patients to be eligible for Cohort 4: Prior RHC not meeting the definition of PH as described in Inclusion Criterion 3 but has a pulmonary artery wedge pressure ≤15 mmHg. 8. Co-enrollment in other observational or interventional studies is permitted. 9. Patient is willing and able to provide informed consent and complete surveys/questionnaires in English or Spanish.
Exclusion Criteria:
• Confirmed diagnosis of Group 1, 2, 4, or 5 PH a. In cases in which a patient has a diagnosis of PH-ILD along with a concomitant diagnosis of another PH group (eg, Group 1), enrollment may be permitted at the Investigator's discretion if, in their clinical judgment, PH-ILD is the predominant driver of the patient's PH.
• Confirmed diagnosis of Group 3 PH associated with lung diseases and or hypoxia other than fibrotic ILD, as outlined in Inclusion Criterion 2.
• Patients receiving inhaled treprostinil (Yutrepia™) at Baseline. Patients receiving other forms of PH therapy will be eligible for enrollment.
OTHER: Prospective study assessments
Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Pulmonary Hypertension, Interstitial Lung Disease
pulmonary hypertension, interstitial lung disease, pulmonary hypertension associated with interstitial lung disease
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Study Locations
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| Location | Contacts |
|---|---|
| Advent Health Medical Group Advanced Lung Disease Orlando, Florida | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| AnMed Health Anderson, South Carolina | |
| Ascension St. Vincent Indianapolis, Indiana | |
| Aurora St. Luke's Medical Center Milwaukee, Wisconsin | |
| Auxilio Mutuo Hospital Guaynabo, Puerto Rico | |
| Banner Health - University Medical Center Phoenix Phoenix, Arizona | |
| Baylor University Medical Center Dallas, Texas | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Corewell Health Beamont Troy Hospital Troy, Michigan | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Duke University School of Medicine Durham, North Carolina | |
| East Carolina University Health Greenville, North Carolina | |
| Emory University Atlanta, Georgia | |
| HMH Jersey Shore University Medical Ctr. Neptune City, New Jersey | |
| Houston Methodist Houston, Texas | |
| Inova Medical Group Falls Church, Virginia | |
| Intercoastal Medical Group Sarasota, Florida | |
| Intermountain Medical Center Murray, Utah | |
| Legacy Research Institute Portland, Oregon | |
| Loyola University Medical Center Maywood, Illinois | |
| Marshall Health Huntington, West Virginia | |
| Mayo Clinic - Rochester Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | |
| Morristown Medical Center Morristown, New Jersey | |
| NCH Research Institute Naples, Florida | |
| National Jewish Health Denver, Colorado | Beatrice Kwarteng - (KWARTENGB@NJHealth.org) |
| New York Presbyterian Hospital - Weill Cornell Medicine New York, New York | |
| New York University Langone Medical Center New York, New York | |
| Northwell Health New Hyde Park, New York | |
| Northwestern University Chicago, Illinois | |
| Norton Pulmonary Specialists Louisville, Kentucky | |
| Ohio State Richard M. Ross Heart Hospital Columbus, Ohio | |
| Oklahoma Heart Institute Tulsa, Oklahoma | |
| Oregon Health & Science University Portland, Oregon | |
| Pasquerilla Healthcare Center - Georgetown University Washington D.C., District of Columbia | |
| Pulmonary Associates of Richmond, Inc. Richmond, Virginia | |
| Pulmonix, LLC Greensboro, North Carolina | |
| Sentara Norfolk General Hospital Norfolk, Virginia | |
| Southeastern Cardiology Associates Columbus, Georgia | |
| St. Luke's University Health Network Easton, Pennsylvania | |
| StatCare Pulmonary Consultants and Center for Biomedical Research Knoxville, Tennessee | |
| Summit Health Florham Park, New Jersey | |
| Tampa General Hospital/University of South Florida Health Tampa, Florida | |
| Temple Lung Center Philadelphia, Pennsylvania | |
| Temple University Hospital Philadelphia, Pennsylvania | |
| The Cleveland Clinic Cleveland, Ohio | |
| The University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| Thomas Jefferson University - Sidney Kimmel Medical College Philadelphia, Pennsylvania | |
| UC Davis Health Medical Center Sacramento, California | |
| UT Southwest Medical Center Heart and Lung Clinic Dallas, Texas | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University Medical Center - New Orleans New Orleans, Louisiana | |
| University of Alabama at Birmingham Birmingham, Alabama | |
| University of Cincinnati Medical Center Cincinnati, Ohio | |
| University of Colorado - Anschutz Medical Campus Aurora, Colorado | |
| University of Florida Gainesville, Florida | |
| University of Kansas Medical Center Kansas City, Kansas | |
| University of Maryland Medical Center Baltimore, Maryland | |
| University of New Mexico Health Sciences Center Albuquerque, New Mexico | |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Rochester Medicine Rochester, New York | |
| University of Texas Health Science Center at Houston Houston, Texas | |
| University of Utah Health Salt Lake City, Utah | |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | |
| Virginia Commonwealth University Richmond, Virginia | |
| WakeMed Health and Hospital Raleigh, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | |
| Weston Hospital - Cleveland Clinic Florida Weston, Florida |
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
BioNTech clinical trials patient information - patients@biontech.de
NCT06712316
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Key
Inclusion Criteria:
* Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate organ function as defined in the protocol.
Key Exclusion Criteria:
* Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component.
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
* Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting.
* Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody.
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
* Participants with significant risk of hemorrhage (per investigator clinical judgment).
* Participants have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply. DRUG: Pumitamig, DRUG: Pembrolizumab, DRUG: Carboplatin, DRUG: Pemetrexed, DRUG: Paclitaxel
Non-small Cell Lung Cancer
First-line treatment, Combination with chemotherapy, Combination with other investigational agents, Bispecific antibody, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor (VEGF) A, Immunotherapy, Programmed Death-1 monoclonal antibodies, Pumitamig, Lung cancer, BNT327, Carboplatin, Pemetrexed, Paclitaxel
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Show 365 locations
Study Locations
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| Location | Contacts |
|---|---|
| Acibadem Adana Hospital Adana, | |
| Adana City Training and Research Hospital Adana, | |
| Affiliated Hospital of Hebei University Baoding, | |
| Ageo Central General Hospital Ageo, | |
| Ajou University Hospital Suwon, Gyeonggi-do | |
| Akdeniz University Hospital Antalya, | |
| Alaska Oncology and Hematology, Llc Anchorage, Alaska | |
| Algemeen Ziekenhuis Delta Roeselare, | |
| Ankara Ataturk Sanatoryum Saglik Uygulama ve Arastirma Merkezi Keçiören, | |
| Ankara Bilkent City Hospital Ankara, | |
| Aomori Prefectural Central Hospital Aomori, | |
| Asan Medical Center (AMC) Seoul, | |
| Asklepios Fachkliniken Muenchen Gauting Gauting, | |
| Asklepios Klinik Harburg Hamburg, | |
| Aso Iizuka Hospital Iizuka, Fukuoka | |
| Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita Vitória, | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Azienda Ospedaliera San Giuseppe Moscati Avellino, | |
| Azienda Ospedaliero - Universitaria di Ferrara Cona, | |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi Bologna, | |
| Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona) Cremona, | |
| Bacs- Kiskun Varmegyei Oktatokorhaz Onkoradiologiai Kozpont Kecskemét, | |
| Baptist Cancer Center Southaven, Mississippi | |
| Baptist Health Hardin Elizabethtown, Kentucky | |
| Baptist Health Lexington Lexington, Kentucky | |
| Baptist Medical Center Jacksonville Jacksonville, Florida | |
| Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust Basildon, | |
| Baskent Universitesi Tip Fakultesi Adana Hastanesi Adana, | |
| Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board Glasgow, | |
| Beijing Chest Hospital,Capital Medical University Beijing, | |
| Beijing Friendship Hospital, Capital Medical University Beijing, | |
| Beijing Hospital Beijing, | |
| Bezmialem Foundation University Medical Faculty Istanbul, | |
| Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology Birmingham, Alabama | |
| Bradford Hill Norte Antofagasta, | |
| Bruno Born Hospital Lajeado, | |
| Budapesti Uzsoki Utcai Korhaz Budapest, | |
| CEON Pesquisas São Caetano do Sul, | |
| CHU Caen Normandie Caen, | |
| CHU HELORA, Hopital de Mons - Site Kennedy Mons, | |
| CHU de Rennes, Hopital de Pontchaillou Rennes, | |
| CHUAC Hospital Teresa Herrera A Coruña, | |
| CIC Cochin Pasteur, Hopital Cochin Paris, | |
| CIONC - Centro Integrado de Oncologia de Curitiba Curitiba, | |
| Cairns Hospital Cairns, Queensland | |
| Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals Oxford, | |
| Cancer Care Wollongong Pty Limited Wollongong, New South Wales | |
| Cancer Hospital of Shantou University Medical College Shantou, | |
| Cancer Research Centre Tbilisi, | |
| Cancer Research SA (CRSA) Adelaide, | |
| Cardiomed Cluj-Napoca, | |
| Casa Di Cura Polispecialistica Dott Pederzoli Peschiera del Garda, | |
| Central West Cancer Care Centre Orange, | |
| Centre Francois Baclesse Caen, Calvados | |
| Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre Toulon, | |
| Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.) Créteil, | |
| Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren Limoges, | |
| Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO) Lausanne, | |
| Centre Hospitalier Universitaire d'Angers (CHU Angers) Angers, | |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre Bordeaux, | |
| Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied Clermont-Ferrand, | |
| Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon La Tronche, | |
| Centre Hospitalier de la Cote Basque Bayonne, | |
| Centre Regional Lutte Contre Le Cancer Paul Strauss Strasbourg, | |
| Centro Clinico do Hospital Sao Lucas da PUCRS Porto Alegre, | |
| Centro Gaucho Integrado de Oncologia e Hematologia - Hospital Mae de Deus/AESC Porto Alegre, | |
| Centro Oncologico Riojano Integral (CORI) La Rioja, | |
| Centro Regional Integrado de Oncologia Fortaleza, | |
| Centro de Estudios Clinicos e Investigaciones Medicas (CECIM) Santiago, | |
| Centro de Investigaciones Clinicas. Clinica Viedma S. A Viedma, | |
| Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion) Buenos Aires, | |
| Centro de Investigación Clínica Bradford Hill Recoleta, | |
| Centro di Riferimento Oncologico Aviano, | |
| Centrul de Oncologie Euroclinic SRL Iași, | |
| Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center) Craiova, | |
| Chiangrai Prachanukroh Hospital Chiang Rai, | |
| Chongqing University Three Gorges Hospital Wanzhou, | |
| Chulalongkorn University Bangkok, | |
| Chungbuk National University Hospital Cheongju-si, | |
| Chungnam National University Hospital (CNUH) Daejeon, | |
| Clatterbridge Cancer Centre Liverpool, | |
| Clermont Oncology Center Clermont, Florida | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic - Hillcrest Hospital Mayfield Heights, Ohio | |
| Cleveland Clinic Florida - Martin North Hospital Stuart, Florida | |
| Cleveland Clinic Weston Hospital Weston, Florida | |
| Clinica MD Anderson International Madrid, | |
| Clinica MEDS Lo Barnechea, | |
| Clinica de Neoplasias Litoral LTDA / Catarina Pesquisa Clínica Itajaí, | |
| Clinical Trial Center-Tasman Oncology Research Ltd Southport, | |
| Coltea Clinical Hospital Bucharest, | |
| Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas de Gran Canaria, | |
| Complex Oncological Center Ruse Ltd Rousse, | |
| Complex Oncology Center Plovdiv, | |
| Consorcio Hospitalario Provincial de Castellon Castellon, | |
| Dayton Physicians Network Dayton, Ohio | |
| Dicle University Faculty of Medicine Hospital Diyarbakır, | |
| Dokkyo Medical University Hospital Mibu, | |
| Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii Wroclaw, | |
| Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Ankara, | |
| Dubbo Hospital Dubbo, | |
| Edelenyi Koch Robert Korhaz es Rendelointezet Edelény, | |
| Evangelische Lungenklinik Berlin Berlin, | |
| Exelsus SRL San Miguel de Tucumán, | |
| Faculty of Medicine Vajira Hospital, Navamindradhiraj University Bangkok, | |
| Fletcher Hospital, Inc. dba AdventHealth Hendersonville Hendersonville, North Carolina | |
| Flinders Medical Centre Bedford Park, South Australia | |
| Fondazione IRCCS Istituto Nazionale dei Tumori Milan, | |
| Fondazione Ospedale Isola Tiberina - Gemelli Isola Rome, | |
| Fondazione Policlinico Universitario Campus Bio-Medico Rome, | |
| Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana | |
| Frederick Health Hospital- James M Stockman Cancer Institute Frederick, Maryland | |
| Fudan University - Shanghai Cancer Center (FUSCC) Shanghai, | |
| Funabashi Municipal Medical Center Funabashi, | |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do Rio Preto São José do Vale do Rio Preto, | |
| Fundacion Instituto Valenciano de Oncologia Valencia, | |
| Fundação Pio XII - Hospital de Câncer de Barretos Barretos, | |
| FutureMeds Krakow Krakow, | |
| GHRMSA Hopital Emile Muller Mulhouse, | |
| Gabrail Cancer Center Research Canton, Ohio | |
| Gachon University Gil Medical Center Incheon, Namdong-gu | |
| Gazi University Faculty of Medicine Yenimahalle, | |
| Gaziantep Sanko University Medical Faculty Gaziantep, | |
| Goztepe Prof. Dr. Suleyman Yalcin City Hospital Istanbul, | |
| Groupe Hospitalier Pitie-Salpetriere Paris, | |
| Gulhane Training and Research Hospital Ankara, | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | |
| Gyeongsang National University Hospital (GNUH) Jinju, Gyeongsangnam-do | |
| H. Lee Moffit Cancer center and research institute Tampa, Florida | |
| HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University Nakhon Nayok, | |
| Hacettepe University Medicine Faculty Ankara, | |
| Hamamatsu University Hospital Shizuoka, Hamamatsu, | |
| Helios Klinikum Wuppertal-Universitaet Witten-Herdecke Wuppertal, | |
| High Technology Hospital MedCenter Ltd Batumi, | |
| Hiroshima Prefectural Hospital Hiroshima, | |
| Hiroshima University Hospital Hiroshima, | |
| Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| Hopital Foch Suresnes, | |
| Hopital Lyon Sud Pierre-Bénite, | |
| Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse Lyon, | |
| Hospices Civils de Lyon - Hopital Louis Pradel Bron, | |
| Hospital General Universitario Gregorio Maranon (HGUGM) Madrid, | |
| Hospital General Universitario de Valencia Valencia, | |
| Hospital Nossa Senhora da Conceicao Porto Alegre, Rio Grande do Sul | |
| Hospital Sao Vicente de Paulo (HSVP) Passo Fundo, | |
| Hospital Universitari de Lleida Arnau de Villanova Lleida, | |
| Hospital Universitario 12 de Octubre Madrid, | |
| Hospital Universitario De Leon León, | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario Miguel Servet de Zaragoza Zaragoza, | |
| Hospital Universitario Nuestra Señora de Valme Seville, | |
| Hospital Universitario Puerta de Hierro de Majadahonda Majadahonda, | |
| Hospital Universitario Vall d'Hebron Barcelona, | |
| Hospital Universitario Virgen del Rocio Seville, Andalusia | |
| Hospital Universitario de Badajoz Badajoz, | |
| Hospital Universitario de Canarias S. Cristobal de La Laguna, Tenerife | |
| Hospital Álvaro Cunqueiro Vigo, | |
| Hull University Teaching Hospitals NHS Trust Cottingham, | |
| Humanitas Istituto Clinico Catanese S.p.A Catania, | |
| Hunan Cancer Hospital Changsha, Hunan | |
| Hyogo Cancer Center Akashi, Hyōgo | |
| Hyogo Medical University Hospital Nishinomiya, | |
| ICON Cancer Care - Townsville Townsville, | |
| IEP Sao Lucas Instituto de Ensino e Pesquisa Sao Lucas São Paulo, | |
| IEP São Lucas São Paulo, | |
| IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST) Meldola, | |
| Icon Cancer Centre Kurralta Park Kurralta Park, South Australia | |
| In- Vivo Sp. z o. o. Bydgoszcz, | |
| Indiana University Health University Hospital Indianapolis, Indiana | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux, | |
| Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol Badalona, | |
| Institut Curie - Centre de Recherche Paris, | |
| Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep Villejuif, | |
| Institut Paoli-Calmettes Marseille, Provence-Alpes-Côte d'Azur Region | |
| Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau Saint-Herblain, | |
| Institut de Cancerologie de l'Ouest Paul Papin Angers, | |
| Instituto Argentino de Diagnostico y Tratamiento (IADT) Buenos Aires, | |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals Barcelona, | |
| Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL Londrina, | |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB) Bucharest, | |
| Institutul Regional de Oncologie Iasi Iași, | |
| Instytut MSF Sp. z o.o. Lodz, | |
| Integris Cancer Institute of Oklahoma Oklahoma City, Oklahoma | |
| Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre, | |
| Ishikawa Prefectural Central Hospital Kanazawa, | |
| Istinye University Bahcesehir Liv Hospital Istanbul, | |
| Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) Roma, | |
| Istituto Candiolo IRCCS Candiolo, | |
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) Milan, | |
| Iwate Medical University Hospital Shiwa-gun, Iwate | |
| Japan Community Healthcare Organization Chukyo Hospital Nagoya, | |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet Szolnok, | |
| Jiamusi Cancer Hospital Jiamusi, | |
| Jiangsu Peoples Hospital Nanjing, | |
| Jilin Cancer Hospital Changchun, Jilin | |
| John Muir Clinical Research Center Concord, California | |
| Joondalup Health campus Joondalup, | |
| Kaiserwerther Diakonie - Florence Nightingale Krankenhaus Düsseldorf, | |
| Kantonspital Baden Baden, | |
| Kantonsspital Münsterlingen Münsterlingen, | |
| Karadeniz Technical University Faculty of Medicine Ortahisar, | |
| Katowickie Centrum Onkologii Katowice, | |
| Kettering Medical Center Kettering, Ohio | |
| Klinikum Chemnitz gGmbH Chemnitz, | |
| Klinikum Esslingen GmbH Esslingen am Neckar, | |
| Koc Universitesi Hastanesi (Koc University Hospital) Istanbul, | |
| Kocaeli Universitesi Tip Fakultesi Kocaeli, | |
| Korea University Guro Hospital Seoul, Guro-gu | |
| Krankenhaus Bethanien Moers Moers, | |
| Kurashiki Central Hospital Okayama, | |
| Kurume University Hospital Kurume, | |
| LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic Tbilisi, | |
| Lampang Cancer Hospital Lampang, | |
| Liga Norte Riograndense Contra o Cancer - CECAN Natal, | |
| Liv Hospital Ankara Ankara, | |
| Llc Todua Clinic Tbilisi, | |
| Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen Immenhausen, | |
| MEDSTAR Washington Hospital Center (MedStar Health Research Institute) Washington D.C., District of Columbia | |
| MHAT for Womens Health - Nadezhda OOD Sofia, | |
| MVZ for oncology and hematology Rhein-Kreis Neuss GmbH Neuss, | |
| Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) Hastings, Nebraska | |
| Matsusaka Municipal Hospital Matsusaka, | |
| MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) Washington D.C., District of Columbia | |
| Medical Park Florya Hospital Istanbul, | |
| Medical Park Seyhan Hospital Seyhan, | |
| Medical Point Izmir Hospital Izmir, | |
| Medicalpark Ordu Hospital Ordu, | |
| Memorial Ankara Hospital Ankara, | |
| Mersin City Training and Research Hospital Toroslar, | |
| Mid Florida Cancer Centers Orange City, Florida | |
| Millennium Research and Clinical Development, LLC Houston, Texas | |
| Missouri Cancer Associates Columbia, Missouri | |
| Monash University - Monash Health -Monash Medical Centre Melbourne, | |
| Municipal Hospital Ploiesti Ploieşti, | |
| Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust Taunton, | |
| NHO Kinki Chuo Chest Medical Center Sakai, | |
| NZOZ Medpolonia Sp. Z o.o. Poznan, | |
| Nagasaki University Hospital Nagasaki, Nagasaki, | |
| Nagoya University Hospital Aichi, Nagoya, | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach Gliwice, | |
| Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Warsaw, | |
| National Cancer Center Goyang-si, Gyeonggi-do | |
| National Hospital Organization Himeji Medical Center Himeji, | |
| National Hospital Organization Iwakuni Clinical Center Iwakuni, | |
| National Hospital Organization Nagoya Medical Center Nagoya, | |
| National Hospital Organization Shikoku Cancer Center Matsuyama, | |
| National Hospital Organization Tokyo Medical Center Meguro City, | |
| Necmettin Erbakan University Meram Medical Faculty Konya, | |
| New Cross Hospital Wolverhampton, West Midlands | |
| New Hospitals Tbilisi, | |
| Niigata Cancer Center Hospital Niigata, | |
| Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich, | |
| Northern Jiangsu Peoples Hospital (NJPH) Yangzhou, | |
| Northwest Georgia Oncology Centers, P.C. Marietta, Georgia | |
| Nuvance Health Poughkeepsie, New York | |
| OC Oncoclínicas - Núcleo de Oncologia da Bahia-Ondina (OC Oncoclinicas-NOB Ondina) Salvador, | |
| ONCOSITE Centro de Pesquisa Clínica Em Oncologia Ijuí, Rio Grande do Sul | |
| Onco Clinic Consult SA Craiova, | |
| Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo) Rio de Janeiro, | |
| Oncology Institute Cluj-Napoca Cluj-Napoca, | |
| Oncomed Timișoara, | |
| Ondokuz Mayis University Health Practice and Research Hospital Samsun, | |
| Onkologische Tagesklinik Remscheid Remscheid, | |
| Orlandi Oncologia Santiago, | |
| Orszagos Onkologiai Intezet (National Institute of Oncology) Budapest, | |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute Osaka, | |
| Ospedale San Luca Lucca, | |
| Ovidius Clinical Hospital Ovidiu, | |
| Peking Union Medical College Hospital Beijing, | |
| Peninsula & South Eastern Haematology and Oncology Group Frankston, Victoria | |
| Peter MacCallum Cancer Centre Melbourne, | |
| Physicians Clinic of Iowa Cedar Rapids, Iowa | |
| Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling Bonn, | |
| Radiotherapy Center Cluj Cluj-Napoca, | |
| Rajavithi Hospital Ratchathewi, | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust Chelsea, London | |
| Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust Sutton, London | |
| Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust Preston, | |
| Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust Brighton, | |
| Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust Bath, | |
| S.C. Medisprof S.R.L, Oncologie medicala Cluj-Napoca, | |
| SC Gral Medical SRL Bucharest, | |
| SPZOZ - Swietokrzyskie Centrum Onkologii Kielce, | |
| SRH Wald-Kliniken Gera GmbH Gera, | |
| SSAK Partners, LLC. Coral Springs, Florida | |
| SSM Health Cancer Care - St. Clare Fenton, Missouri | |
| Saitama Prefectural Cancer Center Saitama, | |
| Sakarya University - Faculty of Medicine Sakarya, | |
| Samsung Medical Center Seoul, | |
| Sanatorio Allende Córdoba, | |
| Sapporo Minamisanjo Hospital Sapporo, | |
| Sendai Kousei Hospital Miyagi, | |
| Seoul National University Bundang Hospital (SNUBH) Seongnam-si, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shandong University - Jinan Central Hospital Jinan, | |
| Shanghai Chest Hospital Shanghai, | |
| Shanghai Pulmonary Hospital Shanghai, | |
| Shenandoah Oncology Winchester, Virginia | |
| Shibukawa Medical Center Shibukawa, | |
| Shizuoka Cancer Center Nagaizumi-cho, Shizuoka | |
| Shonan Kamakura General Hospital Okamoto, | |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou, | |
| Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital Kumamoto, | |
| Southampton General Hospital Southampton, | |
| Staedtisches Klinikum Muenchen Bogenhausen München, | |
| Summit Medical Group PA Florham Park, New Jersey | |
| Suny-Stony Brook University Cancer Center Stony Brook, New York | |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Koszalin, | |
| Taizhou Hospital of Zhejiang Province Zhejiang, | |
| Teine Keijinkai Hospital Sapporo, | |
| The Catholic University of Korea, St. Vincent's Hospital Suwon, Gyeonggi-do | |
| The Christ Hospital Cancer Center Cincinnati, Ohio | |
| The Christie NHS Foundation Trust Manchester, Lancashire | |
| The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion Cleveland, Ohio | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The Third Xiangya Hospital of Central South University Changsha, | |
| The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion Paramus, New Jersey | |
| The first affiliated hospital of bengbu medical college Bengbu, | |
| Thoraxklinik-Heidelberg gGmbH Heidelberg, Baden-Wurttemberg | |
| Tokyo Metropolitan Komagome Hospital Bunkyō City, | |
| Toyama University Hospital Toyama, | |
| UOC Oncoematologia AOU Luigi Vanvitelli Naples, | |
| Uniklinik RWTH Aachen Medizinische Klinik IV Aachen, | |
| Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte Siena, | |
| Universitair Ziekenhuis Gent (Uz Gent) Ghent, | |
| Universitair Ziekenhuis Leuven Leuven, | |
| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) Valencia, | |
| Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert, | |
| University College Hospital Ibadan, | |
| University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna) Sofia, | |
| University Medical Center of Johannes Gutenberg-University Mainz Mainz, | |
| University Of California - San Diego Moores Cancer Center La Jolla, California | |
| University of Cincinnati Medical Center Cincinnati, Ohio | |
| University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center) Lexington, Kentucky | |
| University of Tennessee Medical Center Knoxville, Tennessee | |
| Universitätsklinikum Erlangen Erlangen, | |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Lublin, | |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, | |
| Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii Gdansk, | |
| Utah Cancer Specialists Salt Lake City, Utah | |
| VCU Massey Cancer Center Richmond, Virginia | |
| VITAZ Sint-Niklaas, | |
| Vail Health Vail, Colorado | |
| Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center Nashville, Tennessee | |
| Velindre NHS Trust, Velindre Cancer Centre Cardiff, Wales | |
| Virginia Cancer Specialists Fairfax, Virginia | |
| Virginia Cancer Specialists - Arlington Arlington, Virginia | |
| Wakayama Medical University Hospital Wakayama, | |
| Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie Olsztyn, | |
| West Virginia University Hospitals - Mary Babb Randolph Cancer Center Morgantown, West Virginia | |
| Western Health Sunshine Hospital St Albans, Victoria | |
| Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust Sheffield, | |
| White Plains Hospital White Plains, New York | |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii Poznan, | |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Przemyśl, | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz, | |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw, | |
| Yeditepe University Kosuyolu Hospital Istanbul, | |
| Yokohama Municipal Citizen's Hospital Yokohama, | |
| York Teaching Hospital NHS Foundation Trust - The York Hospital York, | |
| Yunnan Provincial Cancer Hospital Kunming, | |
| Zhejiang Medical University, Zhejiang Cancer Hospital Hangzhou, | |
| Zhongnan Hospital of Wuhan University Wuhan, | |
| hospital Italiano de Buenos Aires CABA, |
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT07100080
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Inclusion Criteria:
* Non-squamous NSCLC, not amenable to treatment in curative intent.
* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).
Exclusion criteria:
* Inadequate organ function and/or bone marrow reserve.
* Leptomeningeal metastases or spinal cord compression.
* Poorly controlled systemic medical conditions.
* Other protocol-defined inclusion/exclusion criteria apply. DRUG: Iza-bren, DRUG: Carboplatin, DRUG: Cisplatin, DRUG: Pemetrexed
Non-small Cell Lung Cancer
Epidermal Growth Factor Receptor, Tyrosine Kinase Inhibitors, Osimertinib, Standard of Care, Lung Neoplasms, Antineoplastic Agents, Izalontamab brengitecan, Iza-bren, BL-B01D1, Carboplatin, Cisplatin, Pemetrexed
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Show 187 locations
Study Locations
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| Location | Contacts |
|---|---|
| Arthur J. E. Child Comprehensive Cancer Centre Calgary, Alberta | |
| Bradfordhill Santiago, Santiago Metropolitan | |
| Cantonal Hospital St.Gallen Sankt Gallen, Canton of St. Gallen | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| E-DA Hospital Kaohsiung City, | |
| FALP Santiago, Santiago Metropolitan | |
| Fujian Cancer Hospital Fuzhou, Fujian | |
| Hospital Privado Universitario de Córdoba Córdoba, | |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | |
| Instituto Alexander Fleming Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Jiangmen Center Hospital Jiangmen, Guangdong | |
| John B Amos Cancer Center Columbus, Georgia | |
| Kantonsspital Baden Baden, | |
| Local Institution - 0010 Lille, Hauts-de-France | |
| Local Institution - 0011 Paris, | |
| Local Institution - 0012 Marseille, | |
| Local Institution - 0014 Strasbourg, Alsace | |
| Local Institution - 0015 Paris, | |
| Local Institution - 0017 Toulouse, Haute-Garonne | |
| Local Institution - 0018 La Tronche, Isère | |
| Local Institution - 0019 Villejuif, Val-de-Marne | |
| Local Institution - 0022 Yvoir, Namur | |
| Local Institution - 0023 Ghent, Oost-Vlaanderen | |
| Local Institution - 0024 Sint-Niklaas, Oost-Vlaanderen | |
| Local Institution - 0025 Houston, Texas | |
| Local Institution - 0028 Ravenna, Emilia-Romagna | |
| Local Institution - 0029 Parma, | |
| Local Institution - 0031 Orbassano, Piedmont | |
| Local Institution - 0032 Milan, | |
| Local Institution - 0034 Naples, | |
| Local Institution - 0036 Aviano, Friuli Venezia Giulia | |
| Local Institution - 0042 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0043 Goyang-si, Kyǒnggi-do | |
| Local Institution - 0044 Seongnam, Kyǒnggi-do | |
| Local Institution - 0045 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0046 Suwon, Kyǒnggi-do | |
| Local Institution - 0054 Athens, Attikí | |
| Local Institution - 0056 Thessaloniki, Kentrikí Makedonía | |
| Local Institution - 0060 Chaïdári, Attikí | |
| Local Institution - 0061 London, Kensington and Chelsea | |
| Local Institution - 0062 Thessaloniki, Thessaloníki | |
| Local Institution - 0069 Bengaluru, Karnataka | |
| Local Institution - 0070 New Delhi, National Capital Territory of Delhi | |
| Local Institution - 0071 Mumbai, Maharashtra | |
| Local Institution - 0072 Gurugram, Haryana | |
| Local Institution - 0073 Ahmedabad, Gujarat | |
| Local Institution - 0077 Mumbai, Maharashtra | |
| Local Institution - 0078 Howrah, West Bengal | |
| Local Institution - 0083 Ahmedabad, Gujarat | |
| Local Institution - 0085 Gainesville, Florida | |
| Local Institution - 0089 Cheongju-si, Chungcheongbuk-do [Chungbuk] | |
| Local Institution - 0092 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0095 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0097 Nagpur, Maharashtra | |
| Local Institution - 0103 Drammen, Buskerud | |
| Local Institution - 0105 Oslo, | |
| Local Institution - 0106 Bergen, Hordaland | |
| Local Institution - 0110 Glasgow, Glasgow City | |
| Local Institution - 0115 Bucharest, | |
| Local Institution - 0119 Iași, | |
| Local Institution - 0120 Bucharest, Bucharest | |
| Local Institution - 0123 Bucharest, Bucharest | |
| Local Institution - 0124 Iași, | |
| Local Institution - 0130 Craiova, Dolj | |
| Local Institution - 0132 Florești, Cluj | |
| Local Institution - 0133 Cluj-Napoca, | |
| Local Institution - 0137 Avellino, | |
| Local Institution - 0140 London, London, City of | |
| Local Institution - 0142 Pembroke Pines, Florida | |
| Local Institution - 0161 Auderghem, Bruxelles-Capitale, Région de | |
| Local Institution - 0162 Bron, Rhône | |
| Local Institution - 0163 Harderwijk, Gelderland | |
| Local Institution - 0164 Amsterdam, North Holland | |
| Local Institution - 0170 Saint-Herblain, Loire-Atlantique | |
| Local Institution - 0173 San Antonio, Texas | |
| Local Institution - 0175 Madrid, Madrid, Comunidad de | |
| Local Institution - 0176 Madrid, Madrid, Comunidad de | |
| Local Institution - 0177 Barcelona, Catalunya [Cataluña] | |
| Local Institution - 0178 Málaga, | |
| Local Institution - 0179 Zaragoza, | |
| Local Institution - 0180 Valencia, | |
| Local Institution - 0181 Majadahonda, Madrid, Comunidad de | |
| Local Institution - 0182 Seville, | |
| Local Institution - 0184 Chicoutimi, Quebec | |
| Local Institution - 0185 Montreal, Quebec | |
| Local Institution - 0189 Bellinzona, | |
| Local Institution - 0191 Kashiwa, Chiba | |
| Local Institution - 0192 Sendai, Miyagi | |
| Local Institution - 0193 Yokohama, Kanagawa | |
| Local Institution - 0194 Ina-machi, Saitama | |
| Local Institution - 0195 Nagaizumi-cho,Sunto-gun, Shizuoka | |
| Local Institution - 0196 Nagoya, Aichi-ken | |
| Local Institution - 0197 Hamamatsu, Shizuoka | |
| Local Institution - 0198 Hirakata, Osaka | |
| Local Institution - 0199 Nishinomiya, Hyōgo | |
| Local Institution - 0200 Kurashiki, Okayama-ken | |
| Local Institution - 0201 Kurume, Fukuoka | |
| Local Institution - 0202 Koto-ku, Tokyo | |
| Local Institution - 0203 Tōon, Ehime | |
| Local Institution - 0204 Ōsaka-sayama, Osaka | |
| Local Institution - 0206 Madrid, Madrid, Comunidad de | |
| Local Institution - 0207 Esslingen am Neckar, Baden-Wurttemberg | |
| Local Institution - 0208 Chemnitz, Saxony | |
| Local Institution - 0209 Oldenburg, Lower Saxony | |
| Local Institution - 0210 Heidelberg, | |
| Local Institution - 0211 Berlin, | |
| Local Institution - 0212 Stuttgart, Baden-Wurttemberg | |
| Local Institution - 0213 Cologne, North Rhine-Westphalia | |
| Local Institution - 0215 Gauting, | |
| Local Institution - 0216 Amsterdam, North Holland | |
| Local Institution - 0217 Sapporo, Hokkaido | |
| Local Institution - 0218 Barcelona, Barcelona [Barcelona] | |
| Local Institution - 0219 Bydgoszcz, | |
| Local Institution - 0220 Lublin, Lublin Voivodeship | |
| Local Institution - 0222 Chihuahua City, | |
| Local Institution - 0223 Mexico City, | |
| Local Institution - 0224 Oaxaca City, Oaxaca | |
| Local Institution - 0225 Mexico City, Mexico City | |
| Local Institution - 0226 Cali, Valle del Cauca Department | |
| Local Institution - 0227 Montería, Departamento de Córdoba | |
| Local Institution - 0228 Bogotá, Cundinamarca | |
| Local Institution - 0229 Valledupar, Cesar Department | |
| Local Institution - 0236 Donauwörth, Bavaria | |
| Local Institution - 0238 Esslingen am Neckar, Baden-Wurttemberg | |
| Local Institution - 0239 Kassel, | |
| Local Institution - 0241 Ulm, | |
| Local Institution - 0242 Hamburg, | |
| Local Institution - 0244 Beijing, Beijing Municipality | |
| Local Institution - 0246 Changchun, Jilin | |
| Local Institution - 0247 Nanchang, Jiangxi | |
| Local Institution - 0248 Jinan, Shandong | |
| Local Institution - 0249 Shanghai, Shanghai Municipality | |
| Local Institution - 0250 Shanghai, Shanghai Municipality | |
| Local Institution - 0251 Linhai, Zhejiang | |
| Local Institution - 0252 Hangzhou, Zhejiang | |
| Local Institution - 0255 Changsha, Hunan | |
| Local Institution - 0256 Xuzhou, Jiangsu | |
| Local Institution - 0257 Shenyang, Liaoning | |
| Local Institution - 0259 Chongqing, Chongqing Municipality | |
| Local Institution - 0260 Nanning, | |
| Local Institution - 0261 Luoyang, Henan | |
| Local Institution - 0264 Bangkok, | |
| Local Institution - 0265 Bangkok, Bangkok | |
| Local Institution - 0266 Songkhla, | |
| Local Institution - 0267 Jingzhou, Hubei | |
| Local Institution - 0268 Chattanooga, Tennessee | |
| Local Institution - 0271 Anyang, Henan | |
| Local Institution - 0272 Mueng, Changwat Khon Kaen | |
| Local Institution - 0274 Kiel, Schleswig-Holstein | |
| Local Institution - 0277 Candiolo, Torino | |
| Local Institution - 0278 Nantes, | |
| Local Institution - 0280 Wilrijk, Antwerpen | |
| Local Institution - 0281 Sulton, Surrey, | |
| Local Institution - 0286 Poznan, Greater Poland Voivodeship | |
| Local Institution - 0287 Chuo-ku, Tokyo | |
| NYU Langone Health New York, New York | |
| National Cancer Centre Singapore Singapore, | |
| National Cheng Kung University Hospital Tainan, | |
| National Taiwan University Hospital Taipei, | |
| Oregon Health and Science University Portland, Oregon | |
| Orlandi Oncologia Santiago, | |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola, New York | |
| Piedmont Healthcare Atlanta, Georgia | |
| Princess Margaret Cancer Centre Toronto, Ontario | |
| Providence Cancer Institute Franz Clinic Portland, Oregon | |
| Providence St. Vincent Medical Center Portland, Oregon | |
| Renown Regional Medical Center Reno, Nevada | |
| Rochester General Hospital Infectious Disease Rochester, New York | |
| Rush University Medical Center Chicago, Illinois | |
| Shanxi Cancer Hospital Taiyuan, Shanxi | |
| Shaw Cancer Center Edwards, Colorado | |
| Taichung Veterans General Hospital Xitun Dist., | |
| Taipei Medical University Hospital Taipei, | |
| Taipei Veterans General Hospital Taipei, | |
| Tan Tock Seng Hospital Singapore, | |
| Tennessee Oncology Nashville, Tennessee | |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C Columbus, Ohio | |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan, Hubei | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building Irvine, California | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange, California | |
| University of Virginia Health System Charlottesville, Virginia | |
| Virginia Commonwealth University (VCU) Richmond, Virginia | |
| Washington University School of Medicine St Louis, Missouri | |
| Weill Cornell Medical College New York, New York | |
| West Penn Allegheny Health Pittsburgh, Pennsylvania | |
| hospital Italiano de Buenos Aires CABA, |
Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com
NCT07227298
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Inclusion Criteria:
* Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
* PD-L1 status available
* Part B only: PD-L1 ≥ TPS 1%
* Measurable disease based on RECIST v1.1 per investigator.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate organ function
Exclusion Criteria:
* Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)
* History of another malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
* Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
* Leptomeningeal disease
* Active autoimmune diseases requiring systemic treatment within the past 2 years
* Previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC
* Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy \>30 Gy to the lung within 6 months of first dose of study intervention BIOLOGICAL: PF-08634404, BIOLOGICAL: Sigvotatug Vedotin, BIOLOGICAL: PF-08046054/SGN-PDL1V
Advanced/Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small Cell Lung, Non-small Cell Lung Cancer
non-small cell lung cancer, NSCLC, advanced solid tumors, metastatic non-small cell lung cancer, locally advanced non-small cell lung cancer, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer
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Show 104 locations
Study Locations
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| Location | Contacts |
|---|---|
| Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) Fano, Pesaro AND Urbino | |
| BRCR Global - Tamarac Tamarac, Florida | |
| BRCR Global Puerto Rico - Hato Rey San Juan, | |
| BRCR Medical Center Inc. Coral Springs, Florida | |
| Beijing Cancer Hospital Beijing, Beijing Municipality | |
| Cadpet Malaga Málaga, | |
| Centre Georges Francois Leclerc Dijon, CÔTE D'OR | |
| Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City, | |
| Clínica Radiólogica Mario Gallegos Málaga, Málaga | |
| Dallas Cancer Specialists Garland, Texas | |
| Fudan University Shanghai Cancer Center Shanghai, Shanghai Municipality | |
| Fujian Cancer Hospital Fuzhou, Fujian | |
| Fundacion Instituto Valenciano de Oncologia Valencia, | |
| Groupe hospitalier Paris saint Joseph Paris, Île-de-France Region | |
| HT Médica Jaen LAs Nieves Jaén, Andalusia | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Heart Center Glenpointe Teaneck, New Jersey | |
| Highlands Oncology Group, PA Springdale, Arkansas | |
| Highlands Oncology Group, PA Springdale, Arkansas | |
| Highlands Oncology Group, PA Springdale, Arkansas | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital Jerez de la Frontera Jerez de la Frontera, | |
| Hospital Nuestra Señora del Rosario Madrid, Madrid, Comunidad de | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario 12 de Octubre Madrid, | |
| Hospital Universitario Puerta del Mar Cadiz, | |
| Hospital Universitario San Cecilio Granada, | |
| Hospital Universitario Virgen Macarena Seville, Sevilla | |
| Hospital Universitario Virgen de la Victoria Málaga, | |
| Hospital Universitario de Jaen Jaén, | |
| IRCCS Istituto Nazionale dei Tumori Regina Elena Roma, ROME | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux, | |
| Institut Paoli-Calmettes Marseille, Provence-Alpes-Côte d'Azur Region | |
| Jack & Sheryl Morris Cancer Center New Brunswick, New Jersey | |
| Jiangsu Province Hospital Nanjing, Jiangsu | |
| John Theurer Cancer Center at From Road Paramus, New Jersey | |
| John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey | |
| John Theurer Cancer Center at JSUMC Neptune City, New Jersey | |
| Kansai Medical University Hospital Hirakata, Osaka | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Krankenhaus Nordwest GmbH Frankfurt am Main, Hesse | |
| LACN Century City Los Angeles, California | |
| Lumi Research Houston, Texas | |
| Mackay Memorial Hospital Taipei, | |
| Marien Hospital Dusseldorf Düsseldorf, North Rhine-Westphalia | |
| Massey Cancer Center Clinical & Translational Research Lab Richmond, Virginia | |
| Mission Community Hospital (Satellite Site) Panorama City, California | |
| Moffitt Cancer Center Tampa, Florida | |
| Moffitt Cancer Center - International Plaza Tampa, Florida | |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | |
| Moffitt Cancer Center - SouthShore Ruskin, Florida | |
| Moffitt Cancer Center - Wesley Chapel Wesley Chapel, Florida | |
| Moffitt Cancer Center- Speros Land O' Lakes, Florida | |
| Moffitt McKinley Hospital Tampa, Florida | |
| Montefiore Medical Center- Montefiore Medical Park The Bronx, New York | |
| National Cancer Center Hospital East Kashiwa, Chiba | |
| National Cheng Kung University Hospital Tainan, | |
| National Taiwan University Hospital Taipei, | |
| Newman Street Imaging Hackensack, New Jersey | |
| Nippon Medical School Hospital Tokyo, Bunkyo-ku, | |
| Oncology Associates of Oregon, P.C. Eugene, Oregon | |
| Orlando Health Ambulatory Care Center Orlando, Florida | |
| Orlando Health Cancer Institute Orlando, Florida | |
| Orlando Health Orlando Regional Medical Center Orlando, Florida | |
| Ospedale Isola Tiberina - Gemelli Isola Roma, ROME | |
| Pan American Center for Oncology Trials, LLC San Juan, | |
| Pan American Center for Oncology Trials, LLC - Mayaguez Mayagüez, | |
| Peking Union Medical College Hospital Beijing, | |
| Providence Medical Foundation Santa Rosa, California | |
| Providence St. Jude Medical Center Fullerton, California | |
| Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center Fullerton, California | |
| Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Robert Wood Johnson University Hospital (RWJBH) New Brunswick, New Jersey | |
| Rocky Mountain Cancer Centers,LLP Denver, Colorado | |
| Rocky Mountain Cancer Centers,LLP Denver, Colorado | |
| Rocky Mountain Cancer Centers,LLP Denver, Colorado | |
| Rutgers Cancer Institute New Brunswick, New Jersey | |
| START Los Angeles, LLC Los Angeles, California | |
| Scripps Clinic Torrey Pines (Scripps Cancer Center) La Jolla, California | |
| Scripps Green Hospital La Jolla, California | |
| Scripps Shiley Pavilion La Jolla, California | |
| Sendai Kousei Hospital Miyagi, | |
| Shanghai Chest Hospital Shanghai, | |
| Shizuoka Cancer Center Nagaizumi-cho, Shizuoka | |
| Southwest Oncology Associates Houston, Texas | |
| Taipei Veterans General Hospital Taipei, | |
| Taizhou Hospital of Zhejiang Province Zhejiang, | |
| Tokyo Metropolitan Komagome Hospital Bunkyō City, | |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Wuhan, Hubei | |
| US Oncology Investigational Products Center (IPC) Irving, Texas | |
| Universitaetsklinikum Freiburg Freiburg im Breisgau, Baden-Wurttemberg | |
| VCU Health Community Memorial Hospital South Hill, Virginia | |
| VCU Health Stony Point Richmond, Virginia | |
| VCU Health Tappahannock Hospital Tappahannock, Virginia | |
| VCU Medical Center Gateway Building Richmond, Virginia | |
| VIVO Capuchinos Seville, | |
| Valkyrie Clinical Trials Los Angeles, California | |
| Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite) Los Angeles, California | |
| Valkyrie Clinical Trials (Additional Site Suite) Los Angeles, California | |
| Virginia Commonwealth University Richmond, Virginia | |
| Virginia Commonwealth University Richmond, Virginia | |
| Voyage Clinical Sugar Land, Texas | |
| mid Florida hematology and Oncology Center Orange City, Florida |
Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
NCT07230288
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Inclusion Criteria:
\- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP.
Exclusion Criteria:
* History of stroke within 6 months prior to screening
* In the opinion of the investigator, other clinically significant pulmonary abnormalities
* History of any malignancy up to 5 years prior screening visit, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix. DRUG: ABBV-142, DRUG: Placebo for ABBV-142
Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
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Show 57 locations
Study Locations
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| Location | Contacts |
|---|---|
| Acibadem City Clinic Tokuda University Hospital EAD /ID# 277846 Sofia, | |
| Caritas-Krankenhaus St. Maria gGmbH /ID# 278138 Donaustauf, Bavaria | |
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 278333 Rennes, Ille-et-Vilaine | |
| Centre d'Investigation Clinique Mauricie /ID# 277949 Trois-Rivières, Quebec | |
| China Medical University Hospital /ID# 278039 Taichung, | |
| Christie Clinic on University /ID# 277871 Champaign, Illinois | |
| Clinical Research Specialists - Kissimmee /ID# 279184 Kissimmee, Florida | |
| Diagnostic Consultative Center Convex /ID# 277848 Sofia, | |
| Diagnostic Consultative Center Convex /ID# 277849 Sofia, | |
| Dr Hannes J van Rensburg inc /ID# 278278 Cape Town, Western Cape | |
| Dr JM Engelbrecht Trial Site /ID# 278287 Somerset West, Western Cape | |
| Eastern Health /ID# 278245 Box Hill, Victoria | |
| Edinburgh Royal Infirmary - NHS Lothian /ID# 278631 Edinburgh, Edinburgh, City of | |
| General Hospital of Chest Diseases of Athens SOTIRIA /ID# 277724 Athens, Attica | |
| General Hospital of Thessaloniki George Papanikolaou /ID# 277819 Thessaloniki, | |
| Gulhane Egitim ve Arastirma Hastanesi /ID# 278944 Ankara, Antalya | |
| Hannibal Regional Hospital /ID# 277984 Hannibal, Missouri | |
| Henry Ford Hospital /ID# 277843 Detroit, Michigan | |
| Hopital Arnaud de Villeneuve /ID# 278322 Montpellier, Herault | |
| Hopital Avicenne /ID# 279212 Bobigny, Île-de-France Region | |
| Hospital Clinico Universitario de Valencia /ID# 277921 Valencia, | |
| Hospital Universitari i Politecnic La Fe /ID# 278478 Valencia, | |
| Inje University Haeundae Paik Hospital /ID# 278000 Busan, Busan Gwang Yeogsi | |
| Inova Fairfax Hospital /ID# 278469 Falls Church, Virginia | |
| Institute For Pulmonary Diseases Of Vojvodina /ID# 278499 Kamenitz, Sremski Okrug | |
| Jefferson Health Honickman Center /ID# 279127 Philadelphia, Pennsylvania | |
| Kaohsiung Chang Gung Memorial Hospital /ID# 278043 Kaohsiung City, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029 Kaohsiung City, | |
| Klinikum Konstanz /ID# 278139 Konstanz, Baden-Wurttemberg | |
| Linkou Chang Gung Memorial Hospital /ID# 278042 Taoyuan City, | |
| Lung Research Queensland /ID# 278838 Nundah, Queensland | |
| Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 278943 Istanbul, | |
| NHO Kinki Chuo Chest Medical Center /ID# 280225 Sakai-shi, Osaka | |
| National Taiwan University Hospital /ID# 278041 Taipei, | |
| Norfolk and Norwich University Hospital /ID# 278224 Norwich, Norfolk | |
| Royal Brompton Hospital /ID# 278007 London, Greater London | |
| Royal Papworth Hospital NHS Foundation Trust /ID# 278055 Cambridge, Cambridgeshire | |
| Sec Clinical Research - East - Dothan - Graceland /ID# 278328 Dothan, Alabama | |
| Seoul National University Bundang Hospital /ID# 278059 Seongnam-si, Gyeonggido | |
| Taipei Veterans General Hospital /ID# 278038 Taipei, | |
| The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 278068 Bucheon-si, Gyeonggido | |
| The University of Alabama at Birmingham /ID# 277613 Birmingham, Alabama | |
| UCLH NHS FT - University College Hospital /ID# 279198 London, Greater London | |
| Unidade Local de Saude de Loures-Odivelas-Hospital Beatriz Angelo /ID# 278357 Loures, Lisbon District | |
| Unidade Local de Saude de Matosinhos EPE /ID# 277980 Senhora da Hora, Porto District | |
| Unidade Local de Saude do Algarve, EPE /ID# 278388 Faro, | |
| University Clinical Center Serbia /ID# 278496 Belgrade, Beograd | |
| University General Hospital of Heraklion /ID# 277717 Heraklion, Crete | |
| University General Hospital of Patras /ID# 277726 Pátrai, Achaia | |
| University Hospital Southampton /ID# 278223 Southampton, Hampshire | |
| University Hospital of Ioannina /ID# 277719 Ioannina, | |
| University Multiprofile Hospital For Active Treatment Sveti Georgi - Plovdiv /ID# 279367 Plovdiv, | |
| University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 277845 Pleven, | |
| University of Michigan Health System - Ann Arbor /ID# 279994 Ann Arbor, Michigan | |
| Virginia Commonwealth University Medical Center /ID# 277992 Richmond, Virginia | |
| Vitamed Galaj i Cichomski Sp.j. /ID# 278145 Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Yonsei University Health System Severance Hospital /ID# 278166 Seoul, Seoul Teugbyeolsi |
Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension (MOMENTOUS)
Momentous Study - momentous-study@tempus.com
NCT06911632
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Inclusion Criteria:
* 18 years or older at the time of consent
* A known diagnosis of interstitial lung disease
* Diffusing capacity for carbon monoxide (DLCO) \<30% predicted, collected within 6 months prior to consent
* Willing and able to provide informed consent and undergo all study-specific procedures, including echo and RHC, if required
Exclusion Criteria:
* A known diagnosis of pulmonary hypertension (including patients prescribed a therapy specifically for pulmonary arterial hypertension (PAH))
* A RHC was completed within the previous 1 year or ordered and not yet completed at the time of consent
* LV ejection fraction ≤ 40% on most recent echo or cardiac MRI, if available
* Unclassifiable Tempus PH ECG risk result after up to 2 ECG acquisitions
* A contraindication to RHC exists (for example, pregnancy or mechanical right heart valve)
* Physician decision that if a patient is directed to RHC by the study protocol, the potential risks of RHC outweigh the potential benefits
* There is a severe concomitant illness limiting life expectancy to less than 6 months (at the discretion of the investigator)
* There is a medical or social factor that makes the patient a poor candidate for the study and/or unlikely to be able to comply with the study protocol or complete study procedures (at the discretion of the investigator) DEVICE: ECG-based AI Device - Results Returned to Investigator, PROCEDURE: Echocardiogram and Right Heart Catheterization, DEVICE: ECG-based AI Device - Results Not Returned to Investigator
Pulmonary Hypertension, Interstitial Lung Disease (ILD)
Pulmonary Hypertension, Interstitial lung disease (ILD)
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Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Kimberly Stark - (kimberly.stark@adventhealth.com) |
| Banner University Medical Center Phoenix, Arizona | Clinical Research Coordinator - (slmarch@arizona.edu) |
| Baylor College of Medicine Houston, Texas | |
| Baylor University Medical Center Dallas, Texas | Brianna Kamran - (Brianna.Kamran@bswhealth.org) |
| Brigham and Women's Hospital Boston, Massachusetts | Clinical Research Coordinator - (eharris@bwh.harvard.edu) |
| CHI Health Creighton University Medical Center - Bergan Mercy Omaha, Nebraska | Chloe Andersen - (chloe.andersen900@commonspirit.org) |
| Community Health Network Indianapolis, Indiana | |
| Corewell Health Royal Oak, Michigan | Bobbie Lewis - (bobbie.lewis@corewellhealth.org) |
| Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute Phoenix, Arizona | Dominique Robertson - (dominique.robertson900@commonspirit.org) |
| HCA Research Institute - Methodist Hospital San Antonio, Texas | Clinical Research Coordinator - (samantha.guerra@hcahealthcare.com) |
| HCA Riverside Community Hospital Riverside, California | Alazzeh - (aalazzeh@pacificpulm.com) |
| Hannibal Regional Healthcare System Hannibal, Missouri | - (humam.farah@hannibalclinic.com) |
| Houston Methodist Hospital Houston, Texas | Rosa De Costa - (zsafdar@houstonmethodist.org) |
| Indiana University Health Methodist Hospital Indianapolis, Indiana | Isabell Mwaura - (imwaura@iu.edu) |
| Louisiana State University Health Shreveport Shreveport, Louisiana | Teresa Leeth - (teresa.leeth@lsuhs.edu) |
| Medical University of South Carolina Charleston, South Carolina | Krishna - (georgjam@musc.edu) |
| Mercy Hospital Springfield Springfield, Missouri | Tracey Haertling - (nathan.frans@mercy.net) |
| National Jewish Health Denver, Colorado | Adrea Arthofer - (arthofera@NJHealth.org) |
| Northwestern University Chicago, Illinois | Taryn Holt - (taryn.holt@northwestern.edu) |
| Renown Regional Medical Center Reno, Nevada | Merlino - (amanda.merlino@renown.org) |
| Southeastern Research Center Winston-Salem, North Carolina | Lauren Miller - (lmiller@southeasternresearchcenter.com) |
| Temple University of The Commonwealth System of Higher Education Philadelphia, Pennsylvania | Kimberly Selwood - (Kim.Selwood@tuhs.temple.edu) |
| Thomas Jefferson University Philadelphia, Pennsylvania | Mallem - (djamila.mallem@jefferson.edu) |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | Jennie Pexa - (jennie.pexa@uhhospitals.org) |
| University of Alabama at Birmingham Birmingham, Alabama | Andrea Ford - (afcook@uabmc.edu) |
| University of Arkansas Little Rock, Arkansas | Clinical Research Coordinator - (blee4@uams.edu) |
| University of Buffalo Buffalo, New York | |
| University of Illinois Health Chicago, Illinois | Dustin Fraidenburg, MD - (dfraiden@uic.edu) |
| University of Kentucky Lexington, Kentucky | Srushan Bhaktula - (ssh486@uky.edu) |
| University of Michigan - Michigan Medicine Ann Arbor, Michigan | Catherine Crombez - (cathercr@med.umich.edu) |
| University of Minnesota Minneapolis, Minnesota | Mandi DeGrote - (carl1032@umn.edu) |
| University of Mississippi Medical Center Jackson, Mississippi | Jaime Brown - (jlbrown@umc.edu) |
| University of New Mexico Albuquerque, New Mexico | Goodale - (LGoodale@salud.unm.edu) |
| University of Oklahoma Oklahoma City, Oklahoma | Maria Mason - (Maria-l-mason@ouhsc.edu) |
| University of Tennessee Knoxville, Tennessee | Herbert - (bherbert@utmck.edu) |
| University of Utah Salt Lake City, Utah | Stefanos Lakonios - (stefan.lakonios@hsc.utah.edu) |
| Virginia Commonwealth University Richmond, Virginia | Robin Toft - (robin.toft@vcuhealth.org) |
| Weill Cornell University Medical College New York, New York | Kimberly Kerr - (kke4001@med.cornell.edu) |
| West Virginia University Hospital Morgantown, West Virginia | Chad Glaze - (cglaze@hsc.wvu.edu) |
| Willis Knighton Health Bossier City, Louisiana | Briana Barrow - (bbarrow@wkhs.com) |