Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
FORTITUDE-102
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression
2 other identifiers
interventional
515
28 countries
342
Brief Summary
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 gastric-cancer
Started Mar 2022
342 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2021
CompletedFirst Posted
Study publicly available on registry
November 8, 2021
CompletedStudy Start
First participant enrolled
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2027
ExpectedDecember 15, 2025
December 1, 2025
3.6 years
October 29, 2021
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Part 1: Number of Participants Who Experienced DLTs
28 days
Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Up to 4.5 years
Part 1: Number of Participants Who Experienced One or More Related TEAEs
Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
Up to 4.5 years
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Up to 4.5 years
Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Up to 4.5 years
Secondary Outcomes (32)
Part 1: Objective Response (OR)
Up to 4.5 years
Part 1: Duration of Response (DoR)
Up to 4.5 years
Part 1: Disease Control Rate (DCR)
Up to 4.5 years
Part 1: Progression Free Survival (PFS)
Up to 4.5 years
Part 1: Overall Survival
Up to 4.5 years
- +27 more secondary outcomes
Study Arms (3)
Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab
EXPERIMENTALParticipants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).
Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
EXPERIMENTALParticipants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.
Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
PLACEBO COMPARATORParticipants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.
Interventions
Bemarituzumab will be administered as intravenous (IV) infusion.
Nivolumab will be administered as IV infusion.
mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion. OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.
Placebo will be administered as IV infusion.
Eligibility Criteria
You may qualify if:
- Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
- Participant has no contraindications to nivolumab and either mFOLFOX6 or CAPOX chemotherapy as per local prescribing information. Participants in Part 1 must have no contraindications to mFOLFOX6. Participants in Part 2 with contraindications to mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no contraindications for this regimen exist. Participants in Part 2 with contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen, if no contraindications for this regimen exist
- Adequate organ function as follows:
- Absolute neutrophil count ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
- Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) \<3 x upper limit of normal (ULN) (or \< 5 x ULN if liver involvement)
- Total bilirubin \<1.5 x ULN (or \< 2 x ULN if liver involvement or Gilbert's disease)
- Part 1 only: Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\] × Mass \[kg\]/\[72 × Creatinine mg/dL\]) (x 0.85 if female).
- Part 2 only: Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\] × Mass \[kg\]/\[72 × Creatinine mg/dL\]) (x 0.85 if female).
- INR or prothrombin time (PT) \< 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
- No prior treatment for metastatic or unresectable disease except for a maximum of
- dose of chemotherapy with or without nivolumab; prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
- +1 more criteria
You may not qualify if:
- Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
- Known positive human epidermal growth factor receptor 2 (HER2) status
- Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
- Peripheral sensory neuropathy grade 2 or higher
- Clinically significant cardiac disease
- Other malignancy within the last 2 years (exceptions for definitively treated disease)
- Chronic or systemic ophthalmologic disorders
- Major surgery or other investigational study within 28 days prior to randomization
- Palliative radiotherapy within 14 days prior to randomization
- Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (348)
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
The Oncology Institute Clinical Research
Cerritos, California, 90703, United States
Cancer and Blood Specialty Clinic
Downey, California, 90241, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California Irvine
Orange, California, 92868, United States
Torrance Memorial Physician Network
Redondo Beach, California, 90277, United States
Translational Research in Oncology - US Inc
Santa Monica, California, 90404, United States
Translational Research in Oncology US Inc, Trio Central Pharmacy
Santa Monica, California, 90404, United States
Olive View-University of California in Los Angeles Medical Center
Sylmar, California, 91342, United States
Presbyterian Intercommunity Hospital Health Whitter Hospital
Whittier, California, 90602, United States
Yale New Haven Hospital Yale Cancer Center
New Haven, Connecticut, 06520, United States
Florida Cancer Specialists - Fort Myers
Fort Myers, Florida, 33901, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Orlando, Florida, 32804, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
University of Illinois Chicago
Chicago, Illinois, 60612, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794-7263, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374, United States
Gabrail Cancer Center, LLC
Canton, Ohio, 44718, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Saint Lukes University Health Network
Allentown, Pennsylvania, 18104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
West Cancer Center
Germantown, Tennessee, 38138, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology Central-South
Austin, Texas, 78705, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
United States Oncology Regulatory Affairs Corporate Office
The Woodlands, Texas, 77380, United States
US Oncology Research Investigational Products Center
The Woodlands, Texas, 77380, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684, United States
Aurora Health Care Metro Inc
Milwaukee, Wisconsin, 53215, United States
Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, 1900, Argentina
Centro Medico Austral
Buenos Aires, Distrito Federal, C1019ABS, Argentina
Fundacion Ars Medica
San Salvador de Jujuy, Jujuy Province, 4600, Argentina
Clinica Viedma
Viedma, Río Negro Province, 8500, Argentina
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS, Argentina
Exelsus Oncologia Clinica
San Miguel de Tucumán, Tucumán Province, T4000, Argentina
Fundacion Respirar
Buenos Aires, C1426ABP, Argentina
Hospital Italiano
Capital Federal, C1199ABB, Argentina
Sanatorio Allende
Córdoba, X5000JHQ, Argentina
Hospital Privado Universitario de Cordoba
Córdoba, X5016KEH, Argentina
Centro Oncologico Riojano Integral
La Rioja, F5300COE, Argentina
GenesisCare -North Shore Oncology
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Grampians Health
Ballarat, Victoria, 3350, Australia
Austin Health, Austin Hospital
Heidelberg, Victoria, 3084, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Landeskrankenhaus Feldkirch
Rankweil, 6830, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Krankenhaus Wiener Neustadt
Wiener Neustadt, 2700, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Institut Jules Bordet
Brussels, B-1070, Belgium
Grand Hopital de Charleroi
Charleroi, 5530, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Hopital De Libramont
Libramont, 6800, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000, Belgium
Algemeen Ziekenhuis Turnhout Campus Sint-Jozef
Turnhout, 2300, Belgium
Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
Fortaleza, Ceará, 60430-230, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil
Hospital Sirio Libanes
Brasília, Federal District, 70200-730, Brazil
Personal Oncologia de Precisao e Personalizada
Belo Horizonte, Minas Gerais, 30130-090, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59075-740, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Fundacao Pio 12 Hospital de Amor de Barretos
Barretos, São Paulo, 14784-400, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, São Paulo, 01221-020, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050, Brazil
Fundacao Antonio Prudente AC Camargo Cancer Center
São Paulo, São Paulo, 01508-010, Brazil
Instituto Coi
Rio de Janeiro, 22793-080, Brazil
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
São Paulo, 04501-000, Brazil
Complex Oncology Center - Burgas
Burgas, 8000, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo, 6300, Bulgaria
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
Panagyurishte, 4500, Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, 4000, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, 1606, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, 1632, Bulgaria
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M4G 2C1, Canada
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Centre Hospitalier de L Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, G1J 1Z4, Canada
Oncocentro Apys
Viña del Mar, Región de Valparaíso, 2520598, Chile
Centro De Estudios Clínicos Suecia SpA
Santiago, Santiago Metropolitan, 7510062, Chile
IC La Serena Research
La Serena, 1720430, Chile
Centro de Estudios Clinicos SAGA Spa
Santiago, 7500653, Chile
Oncovida
Santiago, 7510032, Chile
Icegclinic
Santiago, 8241479, Chile
Centro de Estudios Clinicos e Investigaciones Medicas CeCim
Santiago, 8330336, Chile
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233099, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100032, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733000, China
The first people's Hospital of Foshan
Foshan, Guangdong, 528000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510030, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510180, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, 471000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, 442000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Tongji Hospital Tongji Medical College Of Hust
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Inner Mongolia Autonomous Region Peoples Hospital
Hohhot, Inner Mongolia, 010017, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, 225001, China
Northern Jiangsu Peoples Hospital
Yangzhou, Jiangsu, 225001, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130022, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
Shaanxi Provincial People Hospital
Xi'an, Shaanxi, 710068, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250011, China
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272007, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
Changzhi Peoples Hospital
Changzhi, Shanxi, 046000, China
Linfen Central Hospital
Linfen, Shanxi, 100032, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Tianjin Medical University Cancer institute and hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650106, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000, China
Lishui Municipal central Hospital
Lishui, Zhejiang, 323000, China
The First Affiliate Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 050034, Colombia
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
Rionegro, Antioquia, 054040, Colombia
Sociedad de Oncologia y Hematologia del Cesar
Valledupar, Cesar Department, 200001, Colombia
Fundacion Cardiovascular de Colombia
Bucaramanga, Santander Department, 681017, Colombia
Fundacion Oftalmologica de Santander - Foscal
Floridablanca, Santander Department, 681004, Colombia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Fakultni Thomayerova nemocnice
Prague, 140 59, Czechia
Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
Amiens, 80054, France
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33000, France
Centre Hospitalier Universitaire de Brest - Cavale Blanche
Brest, 29609, France
Centre Hospitalier Universitaire de Clermont Ferrand, Hopital Estaing
Clermont-Ferrand, 63003, France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, 59037, France
Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
Limoges, 87042, France
Centre Leon Berard
Lyon, 69373, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Hopital Saint Louis
Paris, 75475, France
Institut Mutualiste Montsouris
Paris, 75674, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Centre Hospitalier Universitaire de Rouen
Rouen, 76031, France
Centre Rene Gauducheau - Institut de Cancerologie de l Ouest
Saint-Herblain, 44800, France
Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Institut de cancerologie Strasbourg Europe
Strasbourg, 67065, France
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, 60488, Germany
Haematologisch Onkologische Praxis Eppendorf
Hamburg, 20249, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
Regional Kliniken Holding Klinikum Ludwigsburg
Ludwigsburg, 71640, Germany
Johannes Gutenberg Universitaet Mainz
Mainz, 55131, Germany
Universitaetsmedizin Mannheim
Mannheim, 68167, Germany
Klinikum der LMU Muenchen
München, 81377, Germany
Klinikum rechts der Isar der TUM
München, 81675, Germany
Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen
Tübingen, 72076, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, 38440, Germany
Prince of Wales Hospital / CUHK
Shatin, New Territories, Hong Kong
Semmelweis Egyetem
Budapest, 1082, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza, 4400, Hungary
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5000, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Rambam Health Care Campus
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001, Israel
Sheba Medical Center
Ramat Gan, 5262000, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, 60126, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
Bergamo, 24127, Italy
Istituto Ospedaliero Fondazione Poliambulanza
Brescia, 25124, Italy
Ente Ospedaliero IRCCS Saverio De Bellis
Castellana Grotte, 70013, Italy
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Ospedale Policlinico San Martino IRCCS
Genova, 16132, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Naples, 80131, Italy
Istituto Nazionale dei Tumori IRCCS Fondazione Giovanni Pascale
Naples, 80131, Italy
Istituto Oncologico Veneto IRCCS
Padua, 35128, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Gifu University Hospital
Gifu, Gifu, 501-1194, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Beskidzkie Centrum Onkologii Szpital Miejski imienia Jana Pawla Drugiego
Bielsko-Biala, 43-300, Poland
Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
Gliwice, 44-102, Poland
Przychodnia Lekarska Komed Roman Karaszewski
Konin, 62-500, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, 20-080, Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
Olsztyn, 10-228, Poland
Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
Siedlce, 08-110, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, 60-185, Poland
Uniwersytecki Szpital Kliniczny nr 1 im prof Tadeusza Sokolowskiego Pum w Szczecinie
Szczecin, 71-252, Poland
Lux med onkologia sp zoo szpital szamocka
Warsaw, 01-748, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, 02-034, Poland
Mtz Clinical Research powered by Pratia
Warsaw, 02-172, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556, Poland
Unidade Local de Saude de Braga, EPE
Braga, 4710-243, Portugal
Unidade Local de Saude do Alto Ave, EPE
Guimarães, 4835-044, Portugal
Hospital da Luz, SA
Lisbon, 1500-650, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513, Portugal
Hospital Cuf porto
Porto, 4100-180, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, 4200-319, Portugal
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
Cluj-Napoca, 400000, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200542, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Spitalul Municipal Ploiesti
Ploieşti, 100337, Romania
SC Oncomed SRL
Timișoara, 300239, Romania
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
National Cancer Center
Goyang-si Gyeonggi-do, 10408, South Korea
Jeonbuk National University Hospital
Jeonju-si, Jeollabuk-do, 54907, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña, Galicia, 15006, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitario de Elche
Elche, Valencia, 03203, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28009, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Universitaetsspital Basel
Basel, 4031, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Kantonsspital Graubuenden
Chur, 7000, Switzerland
Hopitaux Universitaires de Geneve
Geneva, 1205, Switzerland
Onkozentrum Zuerich
Zurich, 8038, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan District, 33305, Taiwan
Chulabhorn Hospital
Bangkok, 10210, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, 57000, Thailand
Prince of Songkla Hospital
Songkhla, 90110, Thailand
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Ninewells Hospital and Medical School
Dundee, DD1 9SY, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guys Hospital
London, SE1 9RT, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Southampton General Hospital
Southampton, SP16 6YD, United Kingdom
Torbay Hospital
Torquay, TQ2 7AA, United Kingdom
Related Publications (1)
Wainberg ZA, Kang YK, Lee KW, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Zahlten-Kumeli A, Taylor K, Enzinger PC. Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial. Gastric Cancer. 2024 May;27(3):558-570. doi: 10.1007/s10120-024-01466-w. Epub 2024 Feb 3.
PMID: 38308771DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2021
First Posted
November 8, 2021
Study Start
March 14, 2022
Primary Completion
October 14, 2025
Study Completion (Estimated)
January 29, 2027
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.