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15 Study Matches

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

OHB Contact - CMO@Oakhillbio.com

Rozycki, Henry
NCT03253263
HM20016299
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Inclusion Criteria:

• Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
• Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
• Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
Exclusion Criteria:

• Detectable major (or severe) congenital malformation identified before randomization.
• Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
• Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
• Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
• Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
• Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
• The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
• Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
• Birth mother with known HIV or hepatitis (B, C, or E) infection.
DRUG: OHB-607
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
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Study Locations

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Location Contacts
Academisch Medisch Centrum Amsterdam Amsterdam-Zuidoost, North Holland
Arkansas Children's Hospital Little Rock, Arkansas
Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital Chertsey, Surrey
Azienda Ospedaliera Di Padova Padua, Veneto
Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale Florence,
Boston Children's Hospital Boston, Massachusetts
Centro Hospitalar Lisboa Lisbon,
Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E. Porto,
Chelsea and Westminster NHS Trust London,
Children's Hospital of Orange County Orange, California
Children's Minnesota - Children's Hospital and Clinics Saint Paul, Minnesota
Children's Minnesota - Children's Hospital and Clinics - St. Paul Saint Paul, Minnesota
Cork University Maternity Hospital Cork, Wilton
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, Lombardy
Fondazione Policlinico Universitario A Gemelli Rome, Lazio
Groupe Hospitalier Necker Enfants Malades Paris,
Hopital Antoine Beclere Clamart, Hauts-de-Seine
Hospital Garcia de Orta Almada,
Hospital General Universitario Dr. Balmis Alicante,
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Genova,
Jackson Memorial Hospital Miami, Florida
Kagoshima City Hospital Kagoshima, Kagoshima-ken
Karolinska Solna Stockholm,
Klinikum Nürnberg Nuremberg,
Kurashiki Central Hospital Okayama,
LAC USC Medical Center Los Angeles, California
Liverpool Women's Hospital - PPDS Liverpool,
Maastricht University Medical Center Maastricht, Limburg
Maria Fareri Children's Hospital Valhalla, New York
Mater Misericordiae Limited South Brisbane, Queensland
Maternidade Alfredo da Costa Lisbon,
Medical University of South Carolina Children Hospital Charleston, South Carolina
Memorial Hospital of South Bend South Bend, Indiana
Mount Sinai Hospital New York, New York
Nagano Children's Hospital Azumino, Nagano
Nationwide Children's Hospital Columbus, Ohio
Norfolk and Norwich University Hospital Norwich, Norfolk
Norton Children's Hospital Louisville, Kentucky
Ochsner Baptist Medical Center New Orleans, Louisiana
Osaka Women's and Children's Hospital Izumi, Ôsaka
Oulun Yliopistollinen Sairaala Oulu,
Presidio Ospedaliero Di Treviso Ca' Foncello Treviso,
Riley Hospital for Children Indianapolis, Indiana
Royal Hospital for Women Randwick, New South Wales
Royal Women's Hospital Parkville,
Sainte Justine Hospital Montreal, Quebec
Saitama Medical Center Kawagoe-shi, Saitama
Showa Medical University Hospital Tokyo,
Skanes universitetssjukhus Lund,
St. Mary's Hospital Manchester,
Tampa General Hospital Tampa, Florida
Tokyo Metropolitan Children's Medical Center Tokyo,
Tufts Medical Center Boston, Massachusetts
UVA Children's Hospital Charlottesville, Virginia
Universitatsklinikum Freiburg Freiburg im Breisgau,
Universitatsklinikum Leipzig Leipzig,
University College London London,
University Hospital Coventry Coventry,
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of Cambridge Cambridge,
University of Illinois at Chicago Chicago, Illinois
University of Mississippi Medical Center Jackson, Mississippi
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma
University of Rochester Rochester, New York
Virginia Commonwealth University - Children's Hospital of Richmond at VCU Richmond, Virginia
Wilhelmina Children Hospital-University Medical Center Utrecht Utrecht,

A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH) (ROAR)

Bayer Clinical Trials Contact - clinical-trials-contact@bayer.com

Grinnan, Daniel, C
NCT04813926
HM20022707
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Inclusion Criteria:

• Patients aged ≥18 years at the time of riociguat treatment initiation
• Diagnosis of PAH per National Institute for Health and Care Excellence (NICE) 2018 classification
• Decision to initiate treatment with riociguat as per investigator's routine treatment practice made prior to enrollment in the study
• Initiation of riociguat, as per the FDA-approved US label:
• At enrollment OR
• ≤90 days prior to enrollment, with a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)
• Signed informed consent
Exclusion Criteria:

• Previously treated with and discontinued use of riociguat for any reason prior to study enrollment (discontinuation defined as an interruption of therapy ≥30 days)
• Participating in any of the following:
• Blinded clinical trial
• Clinical trial involving an unapproved drug
• Investigational program with interventions outside of routine clinical practice
• Life expectancy <12 months
• Contraindicated to receive riociguat per the FDA approved US label
• Use of nitrates or NO donors in any form
• Use of PDE5 inhibitors
• PH associated with idiopathic interstitial pneumonias
• Unable or unwilling to provide informed consent
Drug: Riociguat (Adempas, BAY63-2521)
Pulmonary Arterial Hypertension
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Study Locations

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Advent Health Orlando, Florida
Advocate Aurora Milwaukee, Wisconsin
Advocate Christ Oak Lawn, Illinois
Allegheny General Hospital Pittsburgh, Pennsylvania
Alliance Pulmonary Guaynabo,
AnMed Health Medical Center Anderson, South Carolina
Banner University Medical Center- Phoenix Phoenix, Arizona
Barnes / Wash U Saint Louis, Missouri
Baylor Scott and White Dallas, Texas
Beaumont Hospital Dublin,
Boston University Boston, Massachusetts
CCF (Cleveland Clinic Florida) Weston, Florida
Cedar Sinai Los Angeles, California
Columbia New York, New York
Froedtert/Medical College of Wisconsin Milwaukee, Wisconsin
Honor Health Scottsdale, Arizona
Houston Methodist Houston, Texas
INTEGRIS Oklahoma City, Oklahoma
KUMC Kansas City, Kansas
Legacy Health Portland, Oregon
Loyola Maywood, Illinois
Mass General Boston, Massachusetts
Mount Sinai New York, New York
NYU Langone New York, New York
Northwell Health New Hyde Park, New York
Northwestern Chicago, Illinois
Norton Pulmonary Specialists Louisville, Kentucky
Premier Pulmonary Denison, Texas
Providence Spokane, Washington
Richmond Pulmonary Associates Richmond, Virginia
Santa Barbara Cottage Hospital Santa Barbara, California
Seton Heart Austin, Texas
St Francis Medical Ctr Columbus, Georgia
St. Louis University St Louis, Missouri
Tampa General Hospital USF Tampa, Florida
Temple University Philadelphia, Pennsylvania
UC Davis Sacramento, California
UC Irvine Orange, California
UCSD San Diego, California
UCSF San Francisco, California
UNMC Omaha, Nebraska
UNMH Albuquerque, New Mexico
USC Los Angeles, California
UT Southwestern Dallas, Texas
Univ of Arizona College of Medicine, Tucson Tucson, Arizona
University of Cincinnati Cincinnati, Ohio
University of Missouri Columbia, Missouri
University of Rochester Rochester, New York
VCU/MCV Richmond, Virginia
Winthrop Mineola, New York

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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Study Locations

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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 Site Public Contact - (research@sncrf.org)
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 Site Public Contact - (connie.szczepanek@crcwm.org)
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
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 - (HemonCCTrials@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 Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pebble Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pecos Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada Site Public Contact - (research@smcrf.org)
Las Vegas Urology - Sunset Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
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
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
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)
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)
OptumCare Cancer Care at Seven Hills Henderson, 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 Site Public Contact - (research@sncrf.org)
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 - (research@sncrf.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 Jude Midwest Affiliate Peoria, Illinois
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 Site Public Contact - (cancer-center@ufl.edu)
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 Comprehensive Cancer Center Ann Arbor, Michigan Site Public Contact - (slusserb@med.umich.edu)
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
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 - 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 Site Public Contact - (ctsucontact@westat.com)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon

ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com

Chaudary, Nauman
NCT05069597
HM20025086
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Inclusion Criteria:

• Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
• Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
• Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.
Exclusion Criteria:

• Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.
Drug: CREON
Cystic Fibrosis, Chronic Pancreatitis
Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase
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Study Locations

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Location Contacts
Albany Medical College-Pulmonary /ID# 250041 Albany, New York
Asr, Llc /Id# 239566 Nampa, Idaho
Atlantic Medical Research Group /ID# 239568 Margate, Florida
Baylor College of Medicine Medical Center /ID# 233441 Houston, Texas
Central FL Pulmonary Orlando /ID# 245863 Orlando, Florida
Children's Hospital of Richmond at VCU /ID# 245988 Richmond, Virginia
Cleveland Clinic Main Campus /ID# 245864 Cleveland, Ohio
Dartmouth-Hitchcock Medical Center /ID# 231633 Lebanon, New Hampshire
GI Pros /ID# 239486 Naples, Florida
NYU Langone Health /ID# 233417 New York, New York
Options Health Research, LLC /ID# 239535 Tulsa, Oklahoma
The Curators of the University of Missouri /ID# 233331 Columbia, Missouri
UH Cleveland Medical Center /ID# 246065 Cleveland, Ohio
UMass Chan Medical School /ID# 230476 Worcester, Massachusetts
Univ Texas HSC San Antonio /ID# 239060 San Antonio, Texas
University of Cincinnati /ID# 229511 Cincinnati, Ohio Site Coordinator
University of Florida - Archer /ID# 233411 Gainesville, Florida
University of Miami, Miller School of Medicine /ID# 239415 Miami, Florida
Valley Children's Hospital /ID# 231452 Madera, California
Velocity Clinical Research /ID# 231076 Mobile, Alabama Site Coordinator
Wake Forest Baptist Health /ID# 229537 Winston-Salem, North Carolina
West Virginia University Hospitals /ID# 239593 Morgantown, West Virginia

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com

NCT06003426
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Inclusion Criteria * Subjects with IPF aged ≥ 40 years at the time of signing the informed consent. * Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia. * If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening. * If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening. * Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test. * Men who are sexually active with women of childbearing potential agree to use male barrier contraception. Exclusion Criteria * History of stroke or transient ischemic attack within 3 months prior to screening. * Participants who exhibit symptoms of heart failure at rest. * Participants who have a current malignancy or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations. * Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: BMS-986278, DRUG: BMS-986278 Placebo
Idiopathic Pulmonary Fibrosis
BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis
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Location Contacts
"Corfu General Hospital ""St. IRINI""" Corfu,
"General Hospital of Thessaloniki ""G. Papanikolaou""" Pylaia-Chortiatis, B
"Ospedale ""Gian Battista Morgagni - Luigi Pierantoni"" di Forli" Forlì,
ACE Hospital & Research Center Pune, Maharashtra
AORN - Ospedali dei Colli Ospedale V. Monaldi Napoli,
Aarhus University Hospital Aarhus,
Accellacare US Inc. of Wilmington Wilmington, North Carolina
Ajou University Hospital Suwon,
All India Institute of Medical Sciences (AIIMS) - New Delhi New Delhi, National Capital Territory of Delhi
Alliance Pulmonary Group Guaynabo, PR
Amsterdam UMC - Locatie VUMC - Pulmonale Hypertensie (PH) Kenniscentrum Amsterdam,
AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine Anderson, South Carolina
Anhui Medical University - Anhui Chest Hospital Hefei, AH
Anhui Medical University - The Second Hospital - Hematological Research Center Hefei, Anhui
Anhui Provincial Hospital Hefei, Anhui
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi Ankara,
Asan Medical Center (AMC) Songpa-gu, Seoul
Aso Iizuka Hospital Iizuka-shi,
Assistance Publique Hopitaux de Marseille - Hopital Nord Marseille,
Asst Papa Giovanni XXIII Bergamo, Lombardy
Asthma Bhawan Jaipur, Rajasthan
Athens Medical Center Marousi, Attica
Avanza Medical Research Center Pensacola, Florida
Azienda Ospedaliera San Paolo Milan,
Azienda Ospedaliera Universitaria - Universita di Sassari Sassari,
Azienda Ospedaliero - Universitaria di Modena Policlinico Modena, Emilia-Romagna
Azienda Ospedaliero Universitaria Pisana Pisa,
Azienda Ospedaliero Universitaria delle Marche Ancona,
Azienda Ospedaliero-Universitaria Careggi Florence,
Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine Houston, Texas
Baylor University Medical Center at Dallas Dallas, Texas
Beijing Chaoyang Hospital, Capital Medical University Beijing, Beijing Municipality
Beijing Friendship Hospital, Capital Medical University Beijing,
Bioreuma Concepción, Bio Bio
Brightshores Health System Owen Sound, Ontario
Burlington Lung Clinic Burlington, Ontario
C.I.C. Joliette Saint-Charles-Borromée, Quebec
C.I.C. Mauricie Inc. Trois-Rivières, Quebec
CEC Centros Estudios Clinicos Santiago, RM
CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo, São Paulo
CENRESIN - Centro Respiratorio Integral Quillota, Región de Valparaíso
CHRU de Tours - Hôpital Bretonneau Tours,
CHU Dijon - Hôpital François Mitterrand Dijon,
CHU Hopitaux de Bordeaux - Hopital Haut-Leveque Pessac,
CHU UCL Namur - Mont-Godinne Yvoir, Namur
CHU de Brest - Hôpital Cavale Blanche Brest,
CHU de Nantes - Hôpital Nord Laennec Nantes, Pays de la Loire Region
Carmel Medical Center Haifa,
Center Hospital of the National Center for Global Health and Medicine Shinjyu-Ku,
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) Grenoble, Auvergne-Rhône-Alpes
Centre Hospitalier Universitaire d'Angers Angers, Maine-et-Loire
Centre Hospitalier Universitaire de Liege - Sart Tilman Liège,
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec
Centro Medico Santa Maria Barra Mansa, Rio de Janeiro
Centro Medico de Enfermedades Respiratorias Florida, B
Centro Respiratorio Quilmes Quilmes, Provincia de Buenos Aires, B
Centro de Estudos de Pneumologia da Faculdade de Medicina do ABC (CEPFMABC) Santo André, São Paulo
Centro de Investigacion Clinica de Oaxaca (CICLO) Oaxaca City, Oaxaca
Centro de Investigacion Curico Curicó, Maule Region
Centro de Investigaciones Metabólicas (CINME) Buenos Aires,
Centro de Investigación Clínica Chapultepec S.A. de C.V. Morelia, Michoacán
Centro de Investigación del Maule Talca,
Centrum Medycyny Oddechowej Bialystok, Podlaskie Voivodeship
Chang Gung Medical Foundation - Kaohsiung Branch Kaohsiung City, Kao-Hsiung
Changhua Christian Hospital Changhua County,
Chiba University Hospital Chiba, Chiba
China Medical University Hospital Taichung,
Christiana Care Pulmonary Associates - Newark Newark, Delaware
Clinica 25 de Mayo Mar del Plata, B
Clinica Providencia San Miguel, LIM
Clinica Universidad de Navarra Madrid,
Clinica Universidad de los Andes Santiago, RM
Clinical Research Specialists, LLC - Kissimmee Kissimmee, Florida
Cliniques Universitaires Saint-Luc Brussels,
Clínica Universidad de Navarra -Madrid Madrid,
Clínica de día Jockey Salud Lima, LIM
Coastal Pulmonary & Critical Care, P.L.C. St. Petersburg, Florida
Connolly Hospital Blanchardstown Dublin,
Consultorios Médicos del Buen Ayre Capital Federal,
David Geffen School of Medicine at UCLA Los Angeles, California
Diex Recherche - Trois-Rivieres Trois-Rivières, Quebec
Dokuz Eylul Universitesi Tip Fakultesi Pasaport,
Duke University Medical Center Durham, North Carolina
Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital) Izmir,
Erasmus MC - Centrum voor Interstitiele Longziekten Rotterdam, South Holland
Erciyes University School of Medicine Kayseri,
Escola Paulista de Medicina São Paulo,
Fachkrankenhaus Coswig GmbH Coswig,
Far Eastern Memorial Hospital New Taipei City,
Fiona Stanley Hospital Murdoch,
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, Lombardy
Fondazione IRCCS Policlinico San Matteo Pavia,
Fondazione IRCCS San Gerardo dei Tintori Monza, Monza and Brianza
Fondazione Policlinico Universitario Agostino Gemelli Roma,
Fortis Hospital Mohali Mohali, Punjab
Fundacion Enfisema - Instituto Ave Pulmo Mar del Plata, Buenos Aires
Fundacion Respirar Buenos Aires,
Fundacion Santa Fe de Bogota Bogotá,
Fundacion Scherbovsky Mendoza, M
Gachon University - Gil Medical Center Incheon,
Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) Greenslopes, Queensland
Gentofte Hospital Hellerup,
Getwell Hospital and Research Institute - Lungs Care Nagpur, Maharashtra
Giromed Institute, SLP Barcelona,
Grant Medical Foundation - Ruby Hall Clinic Pune,
Green City Hospital Bhopal, Madhya Pradesh
Guy's and St Thomas' NHS Foundation Trust - Royal Brompton Hospital London, Greater London
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr,
HELIOS Klinikum Emil von Behring Berlin, State of Berlin
Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem Jerusalem,
Hamamatsu University Hospital Shizuoka, Hamamatsu,
Hangzhou First People's Hospital Hangzhou,
Harmony Medical Research Institute, Inc Hialeah, Florida
Health SURA Calle 100 Bogotá, DC
Health SURA Chipichape Santiago de Cali, VAC
Helsinki University Hospital Heart and Lung Center Helsinki, Etelae-Suomen Laeaeni
Henan provincial people's hospital Zhengzhou, HA
Hiroshima Prefectural Hospital Hiroshima, Hirohima-ken
Hopital Avicenne Bobigny,
Hopitaux Universitaires de Geneve (HUG) Geneva, Canton of Geneva
Hospices Civils de Lyon Bron, Auvergne-Rhône-Alpes
Hospital Alemao Oswaldo Cruz (HAOC) - Centro de Oncologia (Oncology Center) São Paulo,
Hospital CUF Tejo Lisbon,
Hospital Clinic de Barcelona Barcelona,
Hospital Clinico San Carlos Madrid,
Hospital Clinico Universitario Madrid,
Hospital Dia do Pulmão Blumenau, Santa Catarina
Hospital Ernesto Dornelles (HED) Porto Alegre, Rio Grande do Sul
Hospital Madre Teresa Belo Horizonte, Minas Gerais
Hospital Nacional Cayetano Heredia Lima,
Hospital Universitari de Bellvitge (IDIBELL) Barcelona,
Hospital Universitario Central de Asturias Oviedo,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario La Paz Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Puerta De Hierro - Majadahonda Majadahonda, M
Hospital Universitario de La Princesa Madrid,
Hospital das Clínicas da Universidade Federal de Minas Gerais (UFMG) Belo Horizonte, Minas Gerais
Hospital de Santa Marta Lisbon,
Huadong Hospital Affiliated to Fudan University Shanghai,
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital Cottingham, Yorkshire and the Humber
Hôpital Bichat - Claude-Bernard Paris,
Hôpital Larrey Toulouse,
Ibamedica Santa Fe,
Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'yeogsi
Inje University Haeundae Paik Hospital Busan,
Inje University Ilsan Paik Hospital Goyang-si,
Inselspital - Universitaetsklinik Bern für Pneumologie Bern, Canton of Bern
Inspiration Research Toronto, Ontario
Institute for Respiratory Health Nedlands, Western Australia
Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku,
Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM) San Juan Bautista, Buenos Aires
Instituto Medico DAMIC Córdoba, Córdoba Province
Instituto Medico INSARES SA Mendoza, M
Instituto Medico de la Fundacion de Estudios Clínicos Rosario, S
Instituto Neumologico del Oriente Floridablanca, Santander Department
Instituto de Seguridad Social del Estado de Mexico y Municipios (ISSEMYM) - Centro Medico Toluca Metepec, Edo De Mexico
Investigaciones en Patologias Respiratorias San Miguel de Tucuman, Tucumán, T
Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi Topkapı,
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Palermo,
Jehangir Clinical Development Center Pune, Maharashtra
Jichi Medical University Hospital Shimotsuke,
Jizankai Medical Foundation Tsuboi Cancer Center Hospital Koriyama-shi, Fukushima
Juntendo University Hospital Bunkyō City,
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, Karnataka
Kameda Medical Center - Kameda Clinic Kamogawa-shi, Chiba
Kanagawa Cardiovascular and Respiratory Center Yokohama,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Kaplan Medical Center Rehovot,
Kepler Universitatsklinikum Linz, Upper Austria
Kindai University Hospital Ōsaka-sayama,
King George's Medical University Lucknow, Uttar Pradesh
Klinikum der Universitat Munchen Munich, Bavaria
Kobe City Medical Center General Hospital Hyōgo,
Krankenhaus Hietzing Vienna,
Krankenhaus der Augustinerinnen- Klinik fuer Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin Cologne, Northwest
Kurume University Hospital Kurume-shi, Fukuoka
Kyorin University Hospital Mitaka-shi, Tokyo
Kyushu University Hospital Fukuoka,
Lankenau Medical Center Wynnewood, Pennsylvania
Layrek Clinical Research Tulsa, Oklahoma
Leeds Teaching Hospitals NHS Trust Leeds,
Local Institution - 0001 Lenexa, Kansas
Local Institution - 0006 São Paulo,
Local Institution - 0008 Munster, Northwest
Local Institution - 0014 Salt Lake City, Utah
Local Institution - 0016 Lima, LIM
Local Institution - 0020 Badalona, Barcelona
Local Institution - 0032 Pittsburgh, Pennsylvania
Local Institution - 0043 Changchun, Jilin
Local Institution - 0055 Lima,
Local Institution - 0060 Gainesville, Florida
Local Institution - 0063 Brno, JM
Local Institution - 0070 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0071 L'Hospitalet Del Llobregat, Barcelona [Barcelona]
Local Institution - 0076 Villejuif, Val-de-Marne
Local Institution - 0078 Monterrey, Nuevo León
Local Institution - 0080 Iowa City, Iowa
Local Institution - 0081 Lille, Nord
Local Institution - 0082 Vienna,
Local Institution - 0087 Marseille, Bouches-du-Rhône
Local Institution - 0091 Victoria, British Columbia
Local Institution - 0094 Evanston, Illinois
Local Institution - 0100 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0104 Atlanta, Georgia
Local Institution - 0112 Buenos Aires,
Local Institution - 0115 Busan, Pusan-Kwangyǒkshi
Local Institution - 0116 Deagu, Taegu-Kwangyǒkshi
Local Institution - 0133 Milano, MI
Local Institution - 0136 Buenos Aires,
Local Institution - 0141 Aguascalientes, AGU
Local Institution - 0148 Katowice,
Local Institution - 0156 Piura, PIU
Local Institution - 0157 Valencia, Comunidad Valencia
Local Institution - 0162 Monterrey, Nuevo Leon
Local Institution - 0163 Córdoba, VER
Local Institution - 0179 Jasper, Alabama
Local Institution - 0182 Chicago, Illinois
Local Institution - 0190 Buffalo, New York
Local Institution - 0192 Milwaukee, Wisconsin
Local Institution - 0195 Springfield, Massachusetts
Local Institution - 0203 Exeter, South West
Local Institution - 0208 Edmonton, Alberta
Local Institution - 0212 Talcahuano, BI
Local Institution - 0217 Sherbrooke, Quebec
Local Institution - 0219 Exeter, South West
Local Institution - 0223 La Tronche, Isère
Local Institution - 0234 Mérida, YUC
Local Institution - 0245 Nagpur, Maharashtra
Local Institution - 0248 Guadalajara, JAL
Local Institution - 0253 Melbourne, Victoria
Local Institution - 0277 Uppsala, Uppsala Län [se-03]
Local Institution - 0280 Helsinki,
Local Institution - 0281 Oulu, North Ostrobothnia
Local Institution - 0293 Darlinghurst, New South Wales
Local Institution - 0296 Zhengzhou Shi, Henan
Local Institution - 0303 Murdoch, Western Australia
Local Institution - 0308 Paris,
Local Institution - 0310 Milano, MI
Local Institution - 0311 Lille CEDEX,
Local Institution - 0312 Incheon,
Local Institution - 0315 Caen,
Local Institution - 0316 Deogyang-Gu, Goyang-Si,
Local Institution - 0317 Kitakyushu-shi, Fukuoka-Ken
Local Institution - 0327 Sapporo, Hokkaido
Local Institution - 0329 Okayama,
Local Institution - 0340 Olomouc,
Local Institution - 0357 Gosford, New South Wales
Local Institution - 0376 Yinchuan,
Local Institution - 0381 London, LND
Local Institution - 0384 Koblenz, Rhineland-Palatinate
Local Institution - 0387 Linz,
Local Institution - 0390 Zagreb, City of Zagreb
Local Institution - 0392 Sofia,
Local Institution - 0397 Chaïdári, Attikí
Local Institution - 0399 Athens, Attikí
Local Institution - 0401 Miami, Florida
Local Institution - 0412 A Coruña, A Coruña [La Coruña]
Local Institution - 0413 Guadalajara,
Local Institution - 0422 Ankara,
Local Institution - 0423 Kitakyushu-shi, Fukuoka
Local Institution - 0427 Singapore, Central Singapore
Local Institution - 0432 George Town, Pulau Pinang
Local Institution - 0435 Louisville, Kentucky
Local Institution - 0439 Dammam, Eastern Province
Local Institution - 0443 Box Hill, Victoria
Local Institution - 0444 Hermosillo, Sonora
Local Institution - 0445 Riyadh, Riyadh Region
Local Institution - 0446 Buenos Aires,
Local Institution - 0447 Santiago,
Local Institution - 0448 Guadalajara, Jalisco
Local Institution - 0449 Ampang, Selangor
Local Institution - 0450 Tulsa, Oklahoma
Local Institution - 0451 Keçiören/Ankara,
Local Institution - 0452 Atlanta, Georgia
Local Institution - 0453 Lembah Pantai, Kuala Lumpur
Local Institution - 0454 Pilea Chortiatis, Thessaloniki
Local Institution - 0455 Seongnam,
Local Institution - 0460 Graz, Styria
Local Institution - 0462 Auckland,
Local Institution - 0463 Hermosillo, Sonora
Local Institution - 0464 Pilea Chortiatis, Thessaloniki
Local Institution - 0465 Tacoma, Washington
Local Institution - 0466 Pittsburgh, Pennsylvania
Local Institution - 0467 Darlinghurst, New South Wales
Local Institution - 0468 Santiago,
Local Institution - 0469 Rock Hill, South Carolina
Local Institution - 0471 Coimbatore, Tamil Nadu
Local Institution - 0474 Chermside, Queensland
Local Institution - 0475 Eiheiji-cho,Yoshida-gun, Fukui
Local Institution - 0476 Engenho Velho da Federação, Salvador
Local Institution - 0487 Solna, Stockholms Län [se-01]
Local Institution - 0489 Seville,
Local Institution - 0493 Rome, Lazio
Local Institution - 0494 Guadalajara, Jalisco
Local Institution - 0499 Groningen,
Local Institution - 0500 Leiden, South Holland
Local Institution - 0501 Newport Beach, California
Local Institution - 0504 Halle, Saxony-Anhalt
Loyola University Health System Maywood, Illinois
Lungenfachklinik Immenhausen Immenhausen,
MICS Centrum Medyczne Bydgoszcz Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Marengo CIMS Hospital Ahmedabad, Gujarat
Massachusetts General Hospital Boston, Massachusetts
Mater Misericordiae Limited South Brisbane, Queensland
Matsusaka Municipal Hospital Matsusaka-shi, Mie-ken
Max Super Specialty Hospital, Saket - West Block - A Unit of Max Healthcare Institute Limited New Delhi, National Capital Territory of Delhi
McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location Houston, Texas
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical University of South Carolina- College of Medicine Charleston, South Carolina
Medicos Internistas de Caldas Manizales, CL
Mercy St. Vincent Medical Center Toledo, Ohio
Meris Clinical Research Brandon, Florida
Metroplex Pulmonary and Sleep Center McKinney, Texas
Midland Healthcare & Research Center Lucknow,
Monteregie Centre de Recherche Greenfield Park, Quebec
Myongji Hospital Goyang-si, Gyeonggi-do
NHS Lothian - Royal Infirmary of Edinburgh Edinburgh, EDH
NHS Tayside Dundee, DND
NZOZ Przychodnia Vitamed Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Nagasaki University Hospital Nagasaki,
Nagoya University Hospital Nagoya,
Nanfang Hospital of Southern Medical University Guangzhou, Guangdong
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing, JS
National Hospital Organization - Okinawa National Hospital Ginowan-Shi, Okinawa
National Hospital Organization Himeji Medical Center Himeji, Hyōgo
National Hospital Organization Ibarakihigashi National Hospital Naka-gun, Gunma
National Hospital Organization Kinki-Chuo Chest Medical Center Sakai,
National Hospital Organization Kyushu Medical Center Fukuoka,
National Jewish Health Denver, Colorado
National Taiwan University Hospital - The National Center of Excellence for Clinical Trial Taipei,
National Taiwan University Hospital Yun-Lin Branch Yunlin County,
Nilratan Sircar (NRS) Medical College & Hospital Kolkata, West Bengal
Nippon Medical School Hospital Bunkyo-ku, Tokyo
North Bristol NHS Trust - Southmead Hospital Bristol Bristol, BST
Northern Westchester Hospital Mount Kisco, New York
Northwestern Memorial Hospital Chicago, Illinois
Norton Pulmonary Specialists Louisville, Kentucky
OSF Saint Francis Medical Center Peoria, Illinois
OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic Oklahoma City, Oklahoma
Ocala Lung & Critical Care Ocala, Florida
Odense Universitetshospital - Svendborg Sygehus Odense C, Region Syddanmark
Omega Research Consultants LLC DeBary, Florida
Oregon Health & Science University - Pulmonary Clinic Portland, Oregon
Ospedale Colonnello D'Avanzo Foggia Foggia,
Ospedale Policlinico di Siena Siena,
Our Lady of Lourdes Hospital - Drogheda Drogheda, LH
Oxford University Hospitals NHS Trust - Churchill Hospital Oxford, Oxfordshire
Papworth Hospital NHS Foundation Trust Cambridge, Cambridgeshire
Peking Union Medical College Hospital Beijing,
Peking University Shenzhen Hospital Shenzhen,
Peninsula Health - Frankston Hospital Frankston, Victoria
Penn Medicine - Perelman Center for Advanced Medicine Philadelphia, Pennsylvania
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania
Peterborough City Hospital Peterborough,
Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro Rio de Janeiro, Rio de Janeiro
Praxis fur Pneumologie Marburg, HE
Pulmonary Group of Central Florida, LLC - Leesburg Leesburg, Florida
Pulmonary Specialists of the Palm Beaches Loxahatchee Groves, Florida
Pulmonology, Sleep, Asthma & Allergy Center of Dublin Dublin, Georgia
Qilu Hospital of Shandong University Jinan, Shandong
Quebec Heart and Lung Institute Quebec,
Rabin Medical Center - Hasharon Hospital Petah Tikva,
Rambam Health Care Campus - Pulmonology Haifa,
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - South Branch Shanghai, SH
Renmin Hospital of Wuhan University Wuhan,
Respira Salud Clinica Integral Godoy Cruz, M
Royal Adelaide Hospital Adelaide, South Australia
Royal Prince Alfred Hospital Sydney, New South Wales
Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building Chicago, Illinois
SALK - Universitatsklinik Fur Pneumologie/ Lungenheilkunde Landeskrankenhaus Salzburg, Salzburger Land
Saiseikai Kumamoto Hospital Kumamoto,
Santa Casa de Misericórdia de Porto Alegre - Hospital Sao Jose Porto Alegre, Rio Grande do Sul
Santiago Clinic Hospital (Hospital Clínico Universitario de Santiago -CHUS) Santiago de Compostela, Galicia
Sapporo Medical University Hospital Sapporo, Hokkaid
Scripps Clinic Torrey Pines La Jolla, California
Semmelweis Egyetem Pulmonologiai Klinika Budapest,
Seoul National University Bundang Hospital Seongnam,
Seoul National University Hospital Seoul,
Servicios de Salud IPS Suramericana S.A.S - IPS Sura Industriales Medellín Medellín, ANT
Shanghai Jiao Tong University - Shanghai Chest Hospital Shanghai, SH
Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,
Shanghai Pulmonary Hospital Shanghai,
Shengjing Hospital of China Medical University Shenyang, Liaoning
Shenyang Chest Hospital Shenyang, Liaoning
Shenzhen People's Hospital Shenzhen,
Shimane University Hospital Izumo-Shi,
Shree Hospital and Critical Care Centre Nagpur, MH
Shri Guru Ram Rai (SGRR) Institute of Medical and Health Sciences - Shri Mahant Indiresh Hospital Dehradun, Uttarakhand
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital Chengdu,
SoonChunHyang University Bucheon Hospital Bucheon-si,
SoonChunHyang University Seoul Hospital Yongsan-gu, Seoul
South Texas Veterans Health Care System - Audie L. Murphy VA Hospital San Antonio, Texas
Southeastern Research Center Winston-Salem, North Carolina
St Francis Sleep Allergy & Lung Institute Clearwater, Florida
St. Antonius Ziekenhuis Nieuwegein,
St. John's Medical College Bangalore,
St. Joseph's Healthcare Hamilton Hamilton, Ontario
St. Joseph's Hospital and Medical Center Phoenix, Arizona
St. Paul's Hospital Vancouver, British Columbia
St. Vincent's University Hospital Dublin,
Stanford University School of Medicine Stanford, California
Steward St. Elizabeth Medical Center Boston, Massachusetts
Synergy Respiratory & Cardiac Care Sherwood Park, Alberta
T.C.S.B. Süreyyapasa Gögüs Hastaliklari Egitim Ve Arastirma Hastanesi Maltepe,
TC Saglik Bakanlig -Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Arastirma Hastanesi Izmir,
Taichung Veterans General Hospital Taichung,
Taipei Veterans General Hospital Taipei,
Tel Aviv Sourasky Medical Center Tel Aviv,
Temple University Hospital (TUH) - Temple Lung Center (TLC) Philadelphia, Pennsylvania
Tenri Hospital Tenri,
The Affiliated Hospital of Inner Mongolia Medical University Hohhot, Inner Mongolia
The Affiliated Hospital of Xuzhou Medical University Xuzhou,
The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheon-si, Gyeonggi-do
The First Affiliated Hospital of Guangzhou Medical University Guangzhou,
The First Affiliated Hospital of Nanchang University - Xianghu District Nanchang, JX
The First Affiliated Hospital of Ningbo University Ningbo,
The First Affiliated Hospital of Soochow University Suzhou,
The First Affiliated Hospital of Zhengzhou University Zhengzhou,
The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong
The First Hospital of China Medical University Shenyang, Liaoning
The Jikei University Hospital Tokyo,
The Lung Centre Vancouver, British Columbia
The Lung Research Center Chesterfield, Missouri
The Ohio State University Wexner Medical Center Columbus, Ohio
The Prince Charles Hospital Chermside, Queensland
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou,
The Second Hospital of Hebei Medical University Shijiazhuang, Hebei
The Second Xiangya Hospital of Central South University Changsha,
The Third Hospital of Hebei Medical University Shijiazhuang,
The University of Alabama at Birmingham Birmingham, Alabama
The University of Chicago Medicine Chicago, Illinois
Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center Philadelphia, Pennsylvania
Thoraxklinik-Heidelberg gGmbH Heidelberg,
Thoraxzentrum Bezirk Unterfranken Münnerstadt, Bavaria
Tianjin Chest Hospital Tianjin, Tianjin Municipality
Tianjin Medical University General Hospital Tianjin,
Toho University - Omori Medical Center Tokyo,
Tokyo Medical University Hospital Shinjuku-Ku, Tokyo
Toranomon Hospital Tokyo, Minato-ku,
Tosei General Hospital Aichi, Seto,
Turun Yliopistollinen Keskussairaala (TYKS) Turku, Laensi-Suomen Laeaeni
UC Irvine Medical Center Orange, California
UPMC - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD) Pittsburgh, Pennsylvania
UZ Leuven Leuven,
Ulsan University Hospital (UUH) Dong-gu, Ulsan
Uludag Universitesi Tip Fakultesi (Uludag University Faculty of Medicine) Bursa,
Unidade Local de Saude de Gaia/Espinho, EPE Vila Nova de Gaia,
Unidade Local de Saude de Loures - Odivelas, E. P. E. Loures,
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente Lisbon,
Unidade Local de Saude de Santo Antonio, E.P.E. Porto,
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao Porto,
Unidade Local de Saúde do Algarve, EPE Faro,
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei
Unity Hospital Fridley, Minnesota
Universitaetsklinikum Essen - Ruhrlandklinik Essen, North Rhine-Westphalia
Universitaetsklinikum Freiburg - Klinik fuer Pneumologie Freiburg I. Breisgau, Baden-Wurttemberg
Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie Leipzig,
University General Hospital Attikon Athens,
University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital Birmingham, BIR
University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital Birmingham Birmingham,
University of California UC Davis Medical Center Sacramento, California
University of California, San Francisco Medical Center- Pulmonary Practice San Francisco, California
University of Cincinnati College of Medicine Cincinnati, Ohio
University of Colorado Anschutz Medical Campus - Department of Family Medicine Aurora, Colorado
University of Florida (UF) Health Shands Hospital Gainesville, Florida
University of Fukui Hospital Yoshida,
University of Iowa Hospitals and Clinics Iowa City, Iowa
University of Kansas Medical Center (KUMC) Kansas City, Kansas
University of Maryland - Marlene and Stewart Greenebaum Cancer Center Baltimore, Maryland
University of Michigan Ann Arbor, Michigan
University of Patras - Rio Regional University Hospital Rio,
University of South Florida Tampa, Florida
University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic Los Angeles, California
University of Texas Southwestern Medical Center - Pulmonary Specialty Clinic Dallas, Texas
University of Thessaly- General University Hospital of Larissa Larissa,
University of Ulsan College of Medicine - Ulsan University Hospital (UUH) Dong-Gu,
University of Utah, University Hospital Salt Lake City, Utah
University of Washington Medical Center Seattle, Washington
Universitätsklinikum Hamburg-Eppendorf (UKE) Hamburg,
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz,
Universitätsspital Basel Basel,
Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego Lodz,
Uniwersyteckie Centrum Kliniczne Gdansk,
VCU Medical Center Richmond, Virginia
Vanderbilt Lung Institute - One Hundred Oaks Nashville, Tennessee
Velocity Clinical Research Germany GmbH Ahrensburg,
Vivantes Klinikum Neukolln Berlin,
Vzw Az Groeninge Kortrijk,
WM Clinica Pneumologica Sociedade Simples LTDA Porto Alegre, Rio Grande do Sul
Warminsko-Mazurskie Centrum Chorób Pluc w Olsztynie Olsztyn, Warmian-Masurian Voivodeship
Washington University School of Medicine in St. Louis St Louis, Missouri
West China Hospital, Sichuan University Chengdu,
Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location Everett, Washington
Westmead Hospital Westmead, New South Wales
Wiener Gesundheitsverbund - Klinik Floridsdorf Vienna,
Wonkwang University Hospital Iksansi,
Wuxi People's Hospital Wuxi,
Xi'an International Medical Center Hospital Xi'an,
Yale New Haven Hospital New Haven, Connecticut
Yichang Central People's Hospital - Xiling Campus Yichang Shi, HE
Yonsei University Health System, Severance Hospital Seoul,
Zuyderland Medisch Centrum, Sittard-Geleen Heerlen,
hospital Italiano de Buenos Aires CABA,

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

Toll Free Number - Trialsites@msd.com

NCT06074588
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations. * Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1. * Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI. * Measurable disease per RECIST 1.1 as assessed by the local site investigator. * Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided * Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. * Have an ECOG performance status of 0 or 1 within 3 days before randomization.
Exclusion Criteria:
* Has predominantly squamous cell histology NSCLC. * Has mixed tumor(s) with small cell elements. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease. * Has Grade ≥2 peripheral neuropathy. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing. * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib). * Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. * Received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study intervention. * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC). * Received prior treatment with a topoisomerase I-containing ADC. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Active infection requiring systemic therapy. * History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD. * Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
BIOLOGICAL: Sacituzumab tirumotecan, DRUG: Docetaxel, DRUG: Pemetrexed
Non-small Cell Lung Cancer (NSCLC)
Anaplastic lymphoma kinase (ALK), Antibody-drug conjugate (ADC), Epidermal growth factor receptor (EGFR), Trophoblast cell-surface antigen 2 (TROP2)
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Show 192 locations

Study Locations

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Location Contacts
"Theagenio" Cancer Hospital of Thessaloniki ( Site 2703) Thessaloniki, Central Macedonia
A. C. Camargo Cancer Center-CAPEC ( Site 0442) São Paulo,
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704) Chaidari, Athens, Attica
Adana Medical Park Seyhan Hastanesi ( Site 2506) Adana,
Aichi Cancer Center ( Site 3400) Nagoya, Aichi-ken
Anhui Provincial Cancer Hospital ( Site 2830) Hefei, Anhui
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501) Ankara,
Aretaieio Hospital ( Site 2702) Athens, Attica
Asan Medical Center ( Site 3801) Seoul,
Asian Hospital and Medical Center ( Site 3605) Muntinlupa, National Capital Region
Asklepios Klinik Harburg ( Site 1403) Hamburg,
Atlantic Health System Morristown Medical Center ( Site 0031) Morristown, New Jersey
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810) Beijing, Beijing Municipality
Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815) Beijing, Beijing Municipality
Bradfordhill-Clinical Area ( Site 0507) Santiago, Region M. de Santiago
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602) San Juan City, Metro Manila, National Capital Region
CENTRE LEON BERARD ( Site 1305) Lyon Cedex08, Auvergne-Rhône-Alpes
CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300) Rouen, Haute-Normandie
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706) Guadalajara, Jalisco
Cancer Institute Hospital of JFCR ( Site 3402) Koto, Tokyo
Capital Health Medical Center - Hopewell ( Site 0006) Pennington, New Jersey
Centro Investigacion Cancer James Lind ( Site 0513) Temuco, Región de la Araucanía
Centro de Estudios Clínicos SAGA ( Site 0517) Santiago, Region M. de Santiago
Centro de Investigacion Clinica de Oaxaca ( Site 0701) Oaxaca City, Oaxaca
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003) Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Chang Gung Memorial Hospital at Kaohsiung ( Site 3906) Kaohsiung City,
Changhua Christian Hospital ( Site 3908) Changhua,
Chi Mei Medical Center ( Site 3910) Tainan, Tainan
Chiba University Hospital ( Site 3411) Chiba,
Chongqing University Cancer Hospital-Medical Oncology ( Site 2814) Chongqing, Chongqing Municipality
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807) Hwasun, Jeonranamdo
Chungbuk National University Hospital-Internal medicine ( Site 3809) Cheongju-si, North Chungcheong
Chungnam national university hospital ( Site 3808) Junggu, Taejon-Kwangyokshi
Clinica Integral Internacional de Oncología ( Site 0705) Puebla City,
Clinica Universidad Catolica del Maule-Oncology ( Site 0501) Talca, Maule Region
Clinica Universidad de Navarra-Medical Oncology ( Site 2306) Madrid,
Clínica RedSalud Vitacura ( Site 0511) Santiago, Region M. de Santiago
E-Da hospital ( Site 3911) Kaohsiung City,
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504) Bornova, İzmir
Englewood Hospital and Medical Center ( Site 0033) Englewood, New Jersey
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705) Athens, Attica
FALP-UIDO ( Site 0509) Santiago, Region M. de Santiago
Faculty of Medicine - Khon Kaen University ( Site 4004) Khon Kaen,
Faculty of Medicine Siriraj Hospital ( Site 4000) Bangkok, Bangkok
Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102) Olomouc,
Fakultni nemocnice Plzen ( Site 1104) Pilsen, Plzeň Region
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800) Milan, Lombardy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802) Rome, Lazio
Fudan University Shanghai Cancer Center-Oncology ( Site 2811) Shanghai, Shanghai Municipality
Fujian Cancer Hospital ( Site 2819) Fuzhou, Fujian
Fujita Health University Hospital ( Site 3419) Toyoake, Aichi-ken
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444) Barretos, São Paulo
Groupe hospitalier Paris saint Joseph. ( Site 1307) Paris,
Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816) Nanning, Guangxi
Gunma Prefectural Cancer Center ( Site 3418) Otashi, Gunma
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603) London, London, City of
H.R.U Málaga - Hospital General-Oncology ( Site 2302) Málaga, Malaga
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304) Barcelona, Catalonia
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303) Madrid, Madrid, Comunidad de
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301) Pozuelo de Alarcón, Madrid
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500) Ankara,
Hanoi Oncology Hospital ( Site 4102) Hanoi, Hanoi
Harbin Medical University Cancer Hospital-oncology of department ( Site 2807) Harbin, Heilongjiang
Hattiesburg Clinic Hematology/Oncology ( Site 0010) Hattiesburg, Mississippi
Henan Cancer Hospital-henan cancer hospital ( Site 2813) Zhengzhou, Henan
Hong Kong Integrated Oncology Centre ( Site 3200) Central,
Hospital Insular de Gran Canaria-Oncology ( Site 2305) Las Palmas de Gran Canaria, Las Palmas
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440) Porto Alegre, Rio Grande do Sul
Hospital Paulistano-Americas Oncologia ( Site 0441) São Paulo,
Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502) Kota Bharu, Kelantan
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300) Barcelona,
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0704) Monterrey, Nuevo León
Hubei Cancer Hospital ( Site 2809) Wuhan, Hubei
Hunan Cancer Hospital-thoracic oncology II ( Site 2808) Changsha, Hunan
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1806) Meldola, Emilia-Romagna
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303) Bordeaux, Aquitaine
Institut Curie-Thorax Institute ( Site 1304) Paris,
Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 2011) Warsaw, Masovian Voivodeship
Istituto Clinico Humanitas ( Site 1803) Rozzano, Lombardy
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805) Rome, Roma
Jilin Province Tumor Hospital-clinical research ( Site 2803) Changchun, Jilin
Jinan Central Hospital-oncology department ( Site 2802) Jinan, Shandong
K Hospital - National Cancer Hospital ( Site 4105) Hanoi, Hanoi
K2 Oncology ( Site 0514) Santiago, Region M. de Santiago
Kanagawa Cancer Center ( Site 3404) Yokohama, Kanagawa
Kanazawa University Hospital ( Site 3414) Kanazawa, Ishikawa-ken
Kangbuk Samsung Hospital ( Site 3813) Seoul,
Kansai Medical University Hospital ( Site 3410) Hirakata, Osaka
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912) Kaohsiung City,
Karmanos Cancer Institute ( Site 0018) Detroit, Michigan
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400) Essen, North Rhine-Westphalia
Klinikum Chemnitz - Flemmingstraße ( Site 1401) Chemnitz, Saxony
Konkuk University Medical Center ( Site 3812) Seoul,
Korea University Guro Hospital-Internal Medicine ( Site 3800) Seoul,
Kyushu University Hospital ( Site 3407) Fukuoka,
Lampang Cancer Hospital ( Site 4005) Muang, Changwat Lampang
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447) Natal, Rio Grande do Norte
LinYi Cancer Hospital ( Site 2804) Linyi, Shandong
Mackay Memorial Hospital-Chest Medicine ( Site 3902) Taipei,
Maharaj Nakorn Chiang Mai Hospital ( Site 4003) Muang, Chiang Mai
Manila Doctors Hospital-Clinical Trial Office ( Site 3604) Manila, National Capital Region
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1100) Brno, Brno-mesto
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001) Jacksonville, Florida
Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027) Rochester, Minnesota
Medipol Mega Universite Hastanesi-oncology ( Site 2505) Stanbul, Istanbul
Mid Florida Hematology and Oncology Center ( Site 0005) Orange City, Florida
Miyagi Cancer Center ( Site 3416) Natori-shi, Miyagi
Monash Health-Oncology Research ( Site 3001) Clayton, Victoria
Nanjing Drum Tower Hospital ( Site 2812) Nangjing, Jiangsu
Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002) Gliwice, Silesian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000) Warsaw, Masovian Voivodeship
National Cancer Center Hospital East ( Site 3406) Kashiwa, Chiba
National Cancer Center-Lung Cancer Center ( Site 3810) Goyang-si, Kyonggi-do
National Cancer Institute-Radiotherapy and Oncology ( Site 3504) Putrajaya, Kuala Lumpur
National Cheng Kung University Hospital ( Site 3909) Tainan,
National Hospital Organization Kyushu Medical Center ( Site 3412) Fukuoka,
National Hospital Organization Shikoku Cancer Center ( Site 3415) Matsuyama, Ehime
National Lung Hospital-Oncology Department ( Site 4104) Hanoi, Hanoi
National Taiwan University Cancer Center (NTUCC) ( Site 3903) Taipei City, Taipei
National Taiwan University Hospital - Hsinchu branch ( Site 3907) Hsinchu,
National Taiwan University Hospital-Oncology ( Site 3904) Taipei,
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 1103) Ostrava, Ostrava Mesto
Niigata Cancer Center Hospital ( Site 3405) Niigata, Niigata
Nippon Medical School Hospital ( Site 3408) Tokyo,
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003) Marietta, Georgia
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446) São Paulo,
ONCOCENTRO APYS-ACEREY ( Site 0500) Viña del Mar, Región de Valparaíso
Okayama University Hospital ( Site 3417) Okayama,
Orlandi Oncologia-Oncology ( Site 0504) Santiago, Region M. de Santiago
Osaka International Cancer Institute ( Site 3413) Osaka,
Papageorgiou General Hospital of Thessaloniki ( Site 2701) Thessaloniki,
Pontificia Universidad Catolica de Chile ( Site 0502) Santiago, Region M. de Santiago
Princess Margaret Cancer Centre ( Site 0204) Toronto, Ontario
Princess Margaret Hospital-Department of Oncology ( Site 3201) Lai Chi Kok,
Pusan National University Hospital ( Site 3805) Busan, Pusan-Kwangyokshi
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811) Yangsan, Kyongsangnam-do
Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204) Kowloon,
Queen Mary Hospital ( Site 3203) Hksar,
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606) London, Kensington and Chelsea
Rabin Medical Center ( Site 1703) Petah Tikva,
Rambam Health Care Campus-Oncology Division ( Site 1702) Haifa,
Royal Marsden Hospital (Sutton) ( Site 2605) Sutton, Surrey
ST. LUKE'S MEDICAL CENTER ( Site 3601) Quezon City, National Capital Region
Samsung Medical Center-Division of Hematology/Oncology ( Site 3802) Seoul,
Sarawak General Hospital-Radiotherapy Unit ( Site 3500) Kuching, Sarawak
Sendai Kousei Hospital ( Site 3401) Sendai, Miyagi
Seoul National University Bundang Hospital ( Site 3806) Seongnam, Kyonggi-do
Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804) Seoul,
Shaare Zedek Medical Center ( Site 1700) Jerusalem,
Shanghai Chest Hospital-Oncology department ( Site 2800) Shanghai, Shanghai Municipality
Shizuoka Cancer Center ( Site 3403) Nagaizumi-cho,Sunto-gun, Shizuoka
Sichuan Cancer hospital. ( Site 2822) Chengdu, Sichuan
Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828) Hangzhou, Zhejiang
Songklanagarind hospital ( Site 4001) Hat Yai, Changwat Songkhla
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818) Guangzhou, Guangdong
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600) London, London, City of
St. George Private Hospital ( Site 3004) Kogarah, New South Wales
Sunpasitthiprasong Hospital-Oncology ( Site 4002) Ubon Ratchathani,
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005) Kielce, Świętokrzyskie Voivodeship
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502) Istanbul,
THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600) Iloilo City, Iloilo
THE MEDICAL CITY-Cancer Research Center ( Site 3603) Pasig, National Capital Region
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700) Athens, Attica
Taipei Medical University Hospital ( Site 3900) Taipei,
Takarazuka City Hospital ( Site 3409) Takarazuka, Hyōgo
Tennessee Oncology (0036) Nashville, Tennessee Tamjeed Ahmed - (tahmed@tnonc.com)
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803) Suwon, Kyonggi-do
The Christie NHS Foundation Trust ( Site 2604) Manchester,
The Clatterbridge Cancer Centre ( Site 2602) Metropolitan Borough of Wirral,
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817) Xi'an, Shaanxi
The First Affiliated hospital of Xiamen University ( Site 2820) Xiamen, Fujian
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821) Nanchang, Jiangxi
The Second Xiangya Hospital of Central South University ( Site 2827) Changsha, Hunan
Tongji Hospital Tongji Medical,Science & Technology ( Site 2805) Wuhan, Hubei
UCLA Hematology/Oncology - Santa Monica ( Site 0023) Los Angeles, California
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402) Dresden, Saxony
Universitaetsklinikum Freiburg ( Site 1405) Freiburg, Brandenburg
University Of Nebraska Medical Center ( Site 0011) Omaha, Nebraska
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015) Cincinnati, Ohio
University of Texas MD Anderson (0037) Houston, Texas Yasir Elamin - (yyelamin@mdanderson.org)
Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407) Göttingen, Lower Saxony
VCU Health Adult Outpatient Pavillion ( Site 0026) Richmond, Virginia
Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1105) Prague,
West China Hospital, Sichuan University-Lung cancer center ( Site 2826) Chengdu, Sichuan
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003) Melbourne, Victoria
Westmead Hospital ( Site 3000) Westmead, New South Wales
William Osler Health System ( Site 0205) Brampton, Ontario
Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009) Torun, Kuyavian-Pomeranian Voivodeship
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001) Przemyśl, Podkarpackie Voivodeship
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806) Wuhan, Hubei
Yunnan Province Cancer Hospital ( Site 2824) Kunming, Yunnan
Zhejiang Cancer Hospital ( Site 2829) Hangzhou, Zhejiang

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 ETI or ivacaftor 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
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Study Locations

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Location Contacts
Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University Chicago, Illinois Mariah Flowers - (maflowers@luriechildrens.org)
Boston Children's Hospital & Harvard University Boston, Massachusetts Ethan Ito - (ethan.ito@childrens.harvard.edu)
British Columbia Children's Hospital Vancouver, British Columbia Madison Weir - (Madison.Weir@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 Audra Wiser - (wisera@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 Mey Lee - (mey.lee@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 Pavel Tuekam - (OrnellaPavel.TuekamMeko@bcm.edu)
The Children's Hospital Alabama & University of Alabama at Birmingham Birmingham, Alabama Ashlyn Hastings - (aehastings@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) Karen McCarthy - (karen_mccarthy@urmc.rochester.edu)
University of Texas Southwestern & Children's Health Dallas, Texas Lindsay Allen, CRC - (Lindsay.Allen@utsouthwestern.edu)
University of Wisconsin Madison, Wisconsin Melanie Nelson, BS, RRT, CCRC - (mmnelson@medicine.wisc.edu)
Vermont Children's Hospital & University of Vermont Medical Center Burlington, Vermont Vanessa Marascio - (Vanessa.Marascio@uvmhealth.org)
Virginia Commonwealth University Richmond, Virginia Akilah Pierre-Louis, CRC - (Akilah.PierreLouis1@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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Study Locations

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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 Charlotte, 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 Boston, 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 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 * 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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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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Medical University of South Carolina Charleston, South Carolina Ellen Gomez, MA - (gomezel@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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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 Portland, 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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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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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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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 an actionable driver mutation, 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 second-line systemic therapy options if randomized to Arm 2. * 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. * 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. * Patients who are not on actively on ICI or ICI + chemotherapy. * 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: Second-line standard of care therapy
Non-small Cell Lung Cancer
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Alton Memorial Hospital Alton, Illinois
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
City of Hope at Irvine Lennar Irvine, California
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)
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Mercy Hospital Coon Rapids, Minnesota
Miller-Dwan Hospital Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.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
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
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)
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
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
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)
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)