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Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

BioNTech clinical trials patient information - patients@biontech.de

NCT06712316
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Key
Inclusion Criteria:
* Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion). * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Adequate organ function. Key
Exclusion Criteria:
* Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component. * Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: * Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant/adjuvant or locally advanced/metastatic setting. * Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. * Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment. * Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation. * Participants with significant risk of hemorrhage (per investigator clinical judgment). * Have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: Pumitamig, DRUG: Pembrolizumab, DRUG: Carboplatin, DRUG: Pemetrexed, DRUG: Paclitaxel
Non-small Cell Lung Cancer
First-line treatment, Combination with chemotherapy, Combination with other investigational agents, Bispecific antibody, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor (VEGF) A, Immunotherapy, Programmed Death-1 monoclonal antibodies
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Study Locations

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Acibadem Adana Hospital Seyhan, Adana
Adana City Training and Research Hospital Adana,
Affiliated Hospital of Hebei University Baoding,
Ageo Central General Hospital Ageo,
Ajou University Hospital Suwon, Kyǒnggi-do
Akdeniz University Hospital Antalya,
Alaska Oncology and Hematology, Llc Anchorage, Alaska
Ankara Bilkent City Hospital Ankara,
Asan Medical Center (AMC) Seoul,
Asklepios Fachkliniken Muenchen Gauting Gauting,
Astera Cancer Care East Brunswick, New Jersey
Azienda Ospedaliera San Giuseppe Moscati Avellino,
Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi Bologna,
Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona) Cremona,
Baptist Cancer Center Memphis, Tennessee
Baptist Health Hardin Elizabethtown, Kentucky
Baskent Universitesi Tip Fakultesi Adana Hastanesi Adana,
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board Glasgow,
Beijing Friendship Hospital, Capital Medical University Beijing,
Bezmialem Foundation University Medical Faculty Istanbul,
CHU Caen Normandie Caen,
CHU HELORA, Hopital de Mons - Site Kennedy Mons,
CHU de Rennes, Hopital de Pontchaillou Rennes,
Cairns Hospital Cairns,
Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals Oxford,
Cancer Care Wollongong Pty Limited Wollongong,
Cancer Hospital of Shantou University Medical College Shantou,
Cancer Research SA (CRSA) Adelaide,
Cardiomed Cluj-Napoca,
Casa Di Cura Polispecialistica Dott Pederzoli Peschiera del Garda,
Central West Cancer Care Centre Orange,
Centre Francois Baclesse Caen,
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre Toulon,
Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.) Créteil,
Centre Hospitalier Universitaire d'Angers (CHU Angers) Angers,
Centro di Riferimento Oncologico Aviano,
Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center) Craiova,
Chiangrai Prachanukroh Hospital Chiang Rai,
Chongqing University Three Gorges Hospital Wanzhou,
Chulalongkorn University Bangkok,
Chungbuk National University Hospital Cheongju-si, Chungcheongbuk-do [Chungbuk]
Chungnam National University Hospital (CNUH) Daejeon,
Clatterbridge Cancer Centre Metropolitan Borough of Wirral,
Clermont Oncology Center Clermont, Florida
Cleveland Clinic Cleveland, Ohio
Cleveland Clinic - Hillcrest Hospital Mayfield Heights, Ohio
Cleveland Clinic Florida - Martin North Hospital Stuart, Florida
Cleveland Clinic Weston Hospital Weston, Florida
Clinica MD Anderson International Madrid,
Coltea Clinical Hospital Bucharest,
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas de Gran Canaria,
Consorcio Hospitalario Provincial de Castellon Castellon,
Dicle University Faculty of Medicine Hospital Diyarbakır,
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Ankara,
Dubbo Hospital Dubbo,
Evangelische Lungenklinik Berlin Berlin,
Faculty of Medicine Vajira Hospital, Navamindradhiraj University Bangkok,
Fletcher Hospital, Inc. dba AdventHealth Hendersonville Hendersonville, North Carolina
Flinders Medical Centre Bedford PK, South Australia
Fondazione Ospedale Isola Tiberina - Gemelli Isola Rome,
Fondazione Policlinico Universitario Campus Bio-Medico Roma,
Frederick Health Hospital- James M Stockman Cancer Institute Frederick, Maryland
Fundacion Instituto Valenciano de Oncologia Valencia,
Gabrail Cancer Center Research Canton, Ohio
Gachon University Gil Medical Center Namdong-gu, Incheon-gwangyeoksi [incheon]
Gazi University Faculty of Medicine Yenimahalle,
Gaziantep Sanko University Medical Faculty Gaziantep,
Goztepe Prof. Dr. Suleyman Yalcin City Hospital Kadıköy,
Gulhane Training and Research Hospital Ankara,
Gyeongsang National University Hospital (GNUH) Jinju,
H. Lee Moffit Cancer center and research institute Tampa, Florida
HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University Nakhon Nayok,
Hacettepe University Medicine Faculty Ankara,
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke Wuppertal,
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics Iowa City, Iowa
Hospital General Universitario Gregorio Maranon (HGUGM) Madrid,
Hospital General Universitario de Valencia Valencia,
Hospital Universitari de Lleida Arnau de Villanova Lleida,
Hospital Universitario De Leon León,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario Miguel Servet de Zaragoza Zaragoza,
Hospital Universitario Nuestra Señora de Valme Seville,
Hospital Universitario Puerta de Hierro de Majadahonda Majadahonda,
Hospital Universitario Vall d'Hebron Barcelona,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de Badajoz Badajoz,
Hospital Universitario de Canarias San Cristóbal de La Laguna, Santa Cruz De Tenerife
Hospital Álvaro Cunqueiro Vigo,
Hull University Teaching Hospitals NHS Trust Cottingham,
ICON Cancer Care - Townsville Townsville,
IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST) Meldola,
Icon Cancer Centre Kurralta Park Kurralta Park,
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux,
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol Badalona,
Institut Curie - Centre de Recherche Paris,
Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep Villejuif,
Institut Paoli-Calmettes Marseille,
Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau Saint-Herblain,
Instytut MSF Sp. z o.o. Lodz,
Integris Cancer Institute of Oklahoma Oklahoma City, Oklahoma
Istinye University Bahcesehir Liv Hospital Istanbul,
Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) Roma,
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) Milan,
Iwate Medical University Hospital Morioka,
Jiangsu Peoples Hospital Nanjing,
Jilin Cancer Hospital Changchun,
John Muir Clinical Research Center Concord, California
Karadeniz Technical University Faculty of Medicine Ortahisar,
Kettering Medical Center Kettering, Ohio
Klinikum Chemnitz gGmbH Chemnitz,
Klinikum Esslingen GmbH Esslingen am Neckar,
Koc Universitesi Hastanesi (Koc University Hospital) Zeytinburnu,
Kocaeli Universitesi Tip Fakultesi Kocaeli,
Korea University Guro Hospital Seoul, Seoul-teukbyeolsi [Seoul]
Lampang Cancer Hospital Lampang,
Liv Hospital Ankara Ankara,
Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen Immenhausen,
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH Neuss,
Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) Hastings, Nebraska
Matsusaka Municipal Hospital Matsusaka,
Medical Park Florya Hospital Küçükçekmece,
Medical Park Seyhan Hospital Seyhan,
Medical Point Izmir Hospital Izmir,
Memorial Ankara Hospital Ankara,
Mersin City Training and Research Hospital Toroslar,
Millennium Research and Clinical Development, LLC Houston, Texas
Monash University - Monash Health -Monash Medical Centre Melbourne,
Municipal Hospital Ploiesti Ploieşti,
NHO Kinki Chuo Chest Medical Center Sakai,
NZOZ Medpolonia Sp. Z o.o. Poznan,
Nagoya University Hospital Nagoya, Aichi-ken
National Cancer Center Goyang-si, Kyǒnggi-do
National Hospital Organization Himeji Medical Center Himeji, Hyōgo
National Hospital Organization Iwakuni Clinical Center Iwakuni,
National Hospital Organization Nagoya Medical Center Nagoya, Aichi-ken
National Hospital Organization Shikoku Cancer Center Matsuyama, Ehime
National Hospital Organization Tokyo Medical Center Meguro City,
New Cross Hospital Wolverhampton,
Niigata Cancer Center Hospital Niigata, Niigata
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich,
Northern Jiangsu Peoples Hospital (NJPH) Yangzhou,
Onco Clinic Consult SA Craiova,
Oncomed Timișoara,
Ondokuz Mayis University Health Practice and Research Hospital Samsun,
Onkologische Tagesklinik Remscheid Remscheid,
Osaka Prefectural Hospital Organization Osaka International Cancer Institute Osaka,
Ospedale San Luca Lucca,
Ovidius Clinical Hospital Ovidiu,
Peninsula & South Eastern Haematology and Oncology Group Frankston,
Peter MacCallum Cancer Centre Melbourne, Victoria
Physicians Clinic of Iowa Cedar Rapids, Iowa
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling Wesseling,
Radiotherapy Center Cluj Cluj-Napoca,
Rajavithi Hospital Ratchathewi,
Royal Adelaide Hospital Adelaide,
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust Chelsea,
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust London,
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust Preston,
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust Brighton,
S.C. Medisprof S.R.L, Oncologie medicala Cluj-Napoca,
SC Gral Medical SRL Bucharest,
SRH Wald-Kliniken Gera GmbH Gera,
SSM Health Cancer Care - St. Clare Fenton, Missouri
Sakarya University - Faculty of Medicine Sakarya,
Samsung Medical Center Seoul,
Sendai Kousei Hospital Miyagi, Sendai,
Severance Hospital, Yonsei University Health System Seoul,
Shandong University - Jinan Central Hospital Jinan,
Shanghai Chest Hospital Shanghai,
Shizuoka Cancer Center Nakatogari, Shizuoka
Southampton General Hospital Southampton,
Summit Medical Group PA Florham Park, New Jersey
Suny-Stony Brook University Cancer Center Stony Brook, New York
Taizhou Hospital of Zhejiang Province Linhai,
The Catholic University of Korea, St. Vincent's Hospital Suwon,
The Christ Hospital Cancer Center Cincinnati, Ohio
The Christie NHS Foundation Trust Manchester,
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion Cleveland, Ohio
The First Affiliated Hospital of Soochow University Suzhou, Jiangsu
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion Paramus, New Jersey
Thoraxklinik-Heidelberg gGmbH Heidelberg,
Tokyo Metropolitan Komagome Hospital Bunkyō City,
UOC Oncoematologia AOU Luigi Vanvitelli Naples,
Uniklinik RWTH Aachen Medizinische Klinik IV Aachen,
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte Siena,
Universitair Ziekenhuis Leuven Leuven,
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) Valencia,
University College Hospital London,
University Medical Center of Johannes Gutenberg-University Mainz Mainz,
University Of California - San Diego Moores Cancer Center La Jolla, California
University of Cincinnati Medical Center Cincinnati, Ohio
University of Tennessee Medical Center Knoxville, Tennessee
Universitätsklinikum Erlangen Erlangen,
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii Gdansk,
VCU Massey Cancer Center Richmond, Virginia
VITAZ Sint-Niklaas,
Velindre NHS Trust, Velindre Cancer Centre Cardiff,
Virginia Cancer Specialists Fairfax, Virginia
Wakayama Medical University Hospital Wakayama,
Western Health Sunshine Hospital St Albans,
White Plains Hospital White Plains, New York
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Przemyśl,
Yeditepe University Kosuyolu Hospital Istanbul,
Yunnan Provincial Cancer Hospital Kunming,
Zhejiang Medical University, Zhejiang Cancer Hospital Hangzhou,
Zhongnan Hospital of Wuhan University Wuhan,

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

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

NCT07100080
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Inclusion Criteria:
* Non-squamous NSCLC, not amenable to treatment in curative intent. * Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation). * Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting. * Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed). Exclusion criteria: * Inadequate organ function and/or bone marrow reserve. * Leptomeningeal metastases or spinal cord compression. * Poorly controlled systemic medical conditions. * Other protocol-defined inclusion/exclusion criteria apply.
DRUG: Iza-bren, DRUG: Carboplatin, DRUG: Cisplatin, DRUG: Pemetrexed
Non-small Cell Lung Cancer
Epidermal Growth Factor Receptor, Tyrosine Kinase Inhibitors, Osimertinib, Standard of Care, Lung Neoplasms, Antineoplastic Agents, Izalontamab brengitecan, Iza-bren, BL-B01D1, Carboplatin, Cisplatin, Pemetrexed
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Study Locations

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Cantonal Hospital St.Gallen Sankt Gallen, Canton of St. Gallen
Dana-Farber Cancer Institute Boston, Massachusetts
E-DA Hospital Kaohsiung City,
Fujian Cancer Hospital Fuzhou,
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania
Jiangmen Center Hospital Jiangmen, Guangdong
John B Amos Cancer Center Columbus, Georgia
Kantonsspital Baden Baden,
Local Institution - 0004 ABB, Buenos Aires F.D.
Local Institution - 0005 Santiago, Santiago Metropolitan
Local Institution - 0006 Santiago, Santiago Metropolitan
Local Institution - 0007 Santiago, Santiago Metropolitan
Local Institution - 0008 Ciudad Autónoma de Buenos Aires, Buenos Aires
Local Institution - 0010 Lille, Hauts-de-France
Local Institution - 0011 Paris,
Local Institution - 0012 Marseille,
Local Institution - 0014 Strasbourg, Alsace
Local Institution - 0015 Paris,
Local Institution - 0017 Toulouse, Haute-Garonne
Local Institution - 0018 La Tronche, Isère
Local Institution - 0019 Villejuif, Val-de-Marne
Local Institution - 0022 Yvoir, Namur
Local Institution - 0023 Ghent, Oost-Vlaanderen
Local Institution - 0024 Sint-Niklaas, Oost-Vlaanderen
Local Institution - 0025 Houston, Texas
Local Institution - 0028 Ravenna, Emilia-Romagna
Local Institution - 0029 Parma,
Local Institution - 0031 Orbassano, Piedmont
Local Institution - 0032 Milan,
Local Institution - 0034 Naples,
Local Institution - 0036 Aviano, Friuli Venezia Giulia
Local Institution - 0042 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0043 Goyang-si, Kyǒnggi-do
Local Institution - 0044 Seongnam, Kyǒnggi-do
Local Institution - 0045 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0046 Suwon, Kyǒnggi-do
Local Institution - 0054 Athens, Attikí
Local Institution - 0056 Thessaloniki, Kentrikí Makedonía
Local Institution - 0060 Chaïdári, Attikí
Local Institution - 0061 London, Kensington and Chelsea
Local Institution - 0062 Thessaloniki, Thessaloníki
Local Institution - 0069 Bengaluru, Karnataka
Local Institution - 0070 New Delhi, National Capital Territory of Delhi
Local Institution - 0071 Mumbai, Maharashtra
Local Institution - 0072 Gurugram, Haryana
Local Institution - 0073 Ahmedabad, Gujarat
Local Institution - 0077 Mumbai, Maharashtra
Local Institution - 0078 Howrah, West Bengal
Local Institution - 0083 Ahmedabad, Gujarat
Local Institution - 0085 Gainesville, Florida
Local Institution - 0088 Pittsburgh, Pennsylvania
Local Institution - 0089 Cheongju-si, Chungcheongbuk-do [Chungbuk]
Local Institution - 0092 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0094 Córdoba, Córdoba Province
Local Institution - 0095 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0097 Nagpur, Maharashtra
Local Institution - 0103 Drammen, Buskerud
Local Institution - 0105 Oslo,
Local Institution - 0106 Bergen, Hordaland
Local Institution - 0110 Glasgow, Glasgow City
Local Institution - 0115 Bucharest,
Local Institution - 0119 Iași,
Local Institution - 0120 Bucharest, Bucharest
Local Institution - 0123 Bucharest, Bucharest
Local Institution - 0124 Iași,
Local Institution - 0130 Craiova, Dolj
Local Institution - 0132 Florești, Cluj
Local Institution - 0133 Cluj-Napoca,
Local Institution - 0137 Avellino,
Local Institution - 0140 London, London, City of
Local Institution - 0142 Pembroke Pines, Florida
Local Institution - 0153 Chicago, Illinois
Local Institution - 0154 Orange, California
Local Institution - 0158 New York, New York
Local Institution - 0161 Auderghem, Bruxelles-Capitale, Région de
Local Institution - 0162 Bron, Rhône
Local Institution - 0163 Harderwijk, Gelderland
Local Institution - 0164 Amsterdam, North Holland
Local Institution - 0170 Saint-Herblain, Loire-Atlantique
Local Institution - 0171 Portland, Oregon
Local Institution - 0173 San Antonio, Texas
Local Institution - 0175 Madrid, Madrid, Comunidad de
Local Institution - 0176 Madrid, Madrid, Comunidad de
Local Institution - 0177 Barcelona, Catalunya [Cataluña]
Local Institution - 0178 Málaga,
Local Institution - 0179 Zaragoza,
Local Institution - 0180 Valencia,
Local Institution - 0181 Majadahonda, Madrid, Comunidad de
Local Institution - 0182 Seville,
Local Institution - 0184 Chicoutimi, Quebec
Local Institution - 0185 Montreal, Quebec
Local Institution - 0189 Bellinzona,
Local Institution - 0190 Calgary, Alberta
Local Institution - 0191 Kashiwa, Chiba
Local Institution - 0192 Sendai, Miyagi
Local Institution - 0193 Yokohama, Kanagawa
Local Institution - 0194 Ina-machi, Saitama
Local Institution - 0195 Nagaizumi-cho,Sunto-gun, Shizuoka
Local Institution - 0196 Nagoya, Aichi-ken
Local Institution - 0197 Hamamatsu, Shizuoka
Local Institution - 0198 Hirakata, Osaka
Local Institution - 0199 Nishinomiya, Hyōgo
Local Institution - 0200 Kurashiki, Okayama-ken
Local Institution - 0201 Kurume, Fukuoka
Local Institution - 0202 Koto-ku, Tokyo
Local Institution - 0203 Tōon, Ehime
Local Institution - 0204 Ōsaka-sayama, Osaka
Local Institution - 0206 Madrid, Madrid, Comunidad de
Local Institution - 0207 Esslingen am Neckar, Baden-Wurttemberg
Local Institution - 0208 Chemnitz, Saxony
Local Institution - 0209 Oldenburg, Lower Saxony
Local Institution - 0210 Heidelberg,
Local Institution - 0211 Berlin,
Local Institution - 0212 Stuttgart, Baden-Wurttemberg
Local Institution - 0213 Cologne, North Rhine-Westphalia
Local Institution - 0215 Gauting,
Local Institution - 0216 Amsterdam, North Holland
Local Institution - 0217 Sapporo, Hokkaido
Local Institution - 0218 Barcelona, Barcelona [Barcelona]
Local Institution - 0219 Bydgoszcz,
Local Institution - 0220 Lublin, Lublin Voivodeship
Local Institution - 0222 Chihuahua City,
Local Institution - 0223 Mexico City,
Local Institution - 0224 Oaxaca City, Oaxaca
Local Institution - 0225 Mexico City, Mexico City
Local Institution - 0226 Cali, Valle del Cauca Department
Local Institution - 0227 Montería, Departamento de Córdoba
Local Institution - 0228 Bogotá, Cundinamarca
Local Institution - 0229 Valledupar, Cesar Department
Local Institution - 0231 Gdynia, Pomeranian Voivodeship
Local Institution - 0236 Donauwörth, Bavaria
Local Institution - 0238 Esslingen am Neckar, Baden-Wurttemberg
Local Institution - 0239 Kassel,
Local Institution - 0241 Ulm,
Local Institution - 0242 Hamburg,
Local Institution - 0244 Beijing, Beijing Municipality
Local Institution - 0246 Changchun, Jilin
Local Institution - 0247 Nanchang, Jiangxi
Local Institution - 0248 Jinan, Shandong
Local Institution - 0249 Shanghai,
Local Institution - 0250 Shanghai, Shanghai Municipality
Local Institution - 0251 Linhai, Zhejiang
Local Institution - 0252 Hangzhou, Zhejiang
Local Institution - 0255 Changsha, Hunan
Local Institution - 0256 Xuzhou, Jiangsu
Local Institution - 0257 Shenyang, Liaoning
Local Institution - 0259 Chongqing, Chongqing Municipality
Local Institution - 0260 Nanning,
Local Institution - 0261 Luoyang, Henan
Local Institution - 0262 Singapore,
Local Institution - 0263 Singapore,
Local Institution - 0264 Bangkok,
Local Institution - 0265 Bangkok, Bangkok
Local Institution - 0266 Songkhla,
Local Institution - 0267 Jingzhou, Hubei
Local Institution - 0268 Chattanooga, Tennessee
Local Institution - 0271 Anyang, Henan
Local Institution - 0272 Mueng, Changwat Khon Kaen
Local Institution - 0274 Kiel, Schleswig-Holstein
Local Institution - 0277 Candiolo, Torino
Local Institution - 0278 Nantes,
Local Institution - 0279 Irvine, California
Local Institution - 0280 Wilrijk, Antwerpen
Local Institution - 0281 Sulton, Surrey,
Local Institution - 0284 Columbus, Ohio
NYU Langone Health New York, New York
National Cheng Kung University Hospital Tainan,
National Taiwan University Hospital Taipei,
Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola, New York
Piedmont Healthcare Atlanta, Georgia
Princess Margaret Cancer Centre Toronto, Ontario
Providence Cancer Institute Franz Clinic Portland, Oregon
Providence St. Vincent Medical Center Portland, Oregon
Renown Regional Medical Center Reno, Nevada
Rochester General Hospital Infectious Disease Rochester, New York
Shanxi Cancer Hospital Taiyuan, Shanxi
Shaw Cancer Center Edwards, Colorado
Taichung Veterans General Hospital Taichung,
Taipei Medical University Hospital New Taipei City,
Taipei Veterans General Hospital Taipei,
Tennessee Oncology Nashville, Tennessee
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan, Hubei
University Hospitals Cleveland Medical Center Cleveland, Ohio
University of Virginia Health System Charlottesville, Virginia
Virginia Commonwealth University (VCU) Richmond, Virginia
Washington University School of Medicine St Louis, Missouri

Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com

NCT07227298
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Inclusion Criteria:
* Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy * PD-L1 status available * Part B only: PD-L1 ≥ TPS 1% * Measurable disease based on RECIST v1.1 per investigator. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Adequate organ function
Exclusion Criteria:
* Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET * History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy * Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression * Leptomeningeal disease * Active autoimmune diseases requiring systemic treatment within the past 2 years * Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC * Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention
BIOLOGICAL: PF-08634404, BIOLOGICAL: Sigvotatug Vedotin, BIOLOGICAL: Combination Agent 1
Advanced/Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small Cell Lung, Non-small Cell Lung Cancer
non-small cell lung cancer, NSCLC, advanced solid tumors, metastatic non-small cell lung cancer, locally advanced non-small cell lung cancer, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer
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Study Locations

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Location Contacts
BRCR Global - Tamarac Tamarac, Florida
BRCR Global Puerto Rico - Hato Rey San Juan,
BRCR Medical Center Inc. Coral Springs, Florida
Dallas Cancer Specialists Garland, Texas
Highlands Oncology Group, PA Springdale, Arkansas
Highlands Oncology Group, PA Springdale, Arkansas
Highlands Oncology Group, PA Springdale, Arkansas
Kansai Medical University Hospital Hirakata, Osaka
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Lumi Research Houston, Texas
Mackay Memorial Hospital Taipei,
Massey Cancer Center Clinical & Translational Research Lab Richmond, Virginia
National Cheng Kung University Hospital Tainan,
National Taiwan University Hospital Taipei,
Oncology Associates of Oregon, P.C. Eugene, Oregon
Pan American Center for Oncology Trials, LLC Rio Piedras,
Providence Medical Foundation Fullerton, California
Providence St. Jude Medical Center Fullerton, California
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center Fullerton, California
Rocky Mountain Cancer Centers, LLP Denver, Colorado
Shizuoka Cancer Center Nakatogari, Shizuoka
Southwest Oncology Associates Houston, Texas
Taipei Veterans General Hospital Taipei,
US Oncology Investigational Products Center (IPC) Irving, Texas
VCU Health Community Memorial Hospital South Hill, Virginia
VCU Health Stony Point Richmond, Virginia
VCU Health Tappahannock Hospital Tappahannock, Virginia
VCU Medical Center Gateway Building Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia
Voyage Clinical Sugar Land, Texas
mid Florida hematology and Oncology Center Orange City, Florida