Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
FORTITUDE-101
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
2 other identifiers
interventional
547
36 countries
287
Brief Summary
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
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
287 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
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
September 22, 2021
CompletedStudy Start
First participant enrolled
March 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2026
CompletedMay 27, 2026
May 1, 2026
3.3 years
September 13, 2021
May 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Up to approximately 3.5 years
Secondary Outcomes (21)
Progression-free Survival (PFS)
Up to approximately 3.5 years
Objective Response Rate (ORR)
Up to approximately 3.5 years
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Up to approximately 3.5 years
Overall Survival
Up to approximately 3.5 years
Progression-free Survival (PFS)
Up to approximately 3.5 years
- +16 more secondary outcomes
Study Arms (2)
Bemarituzumab with mFOLFOX6
EXPERIMENTALPlacebo with mFOLFOX6
ACTIVE COMPARATORInterventions
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
Eligibility Criteria
You may qualify if:
- Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
- Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
- Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
- Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
- Participant has no contraindications to mFOLFOX6 chemotherapy
- Adequate organ and bone marrow function:
- absolute neutrophil count greater than or equal to 1.5 times 10\^9/L
- platelet count greater than or equal to 100 times 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 aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
- 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)
- international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
You may not qualify if:
- Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
- Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
- Known human epidermal growth factor receptor 2 (HER2) positive
- Untreated or symptomatic central nervous system (CNS) disease or brain metastases
- Peripheral sensory neuropathy greater than or equal to Grade 2
- Clinically significant cardiac disease
- Other malignancy within the last 2 years (exceptions for definitively treated disease)
- Chronic or systemic ophthalmological disorders
- Major surgery or other investigational study within 28 days prior to first dose of study treatment
- Palliative radiotherapy within 14 days prior to the first dose of study treatment
- Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Zai Lab (China only)collaborator
Study Sites (300)
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
The Oncology Institute Clinical Research
Cerritos, California, 90703, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Saint Francis Medical Group
Indianapolis, Indiana, 46237, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Healthier Hematology and Oncology Excelsior Integrated Medical Group
Brooklyn, New York, 11220, United States
White Plains Hospital Center for Cancer Care
White Plains, New York, 10601, United States
Levine Cancer Institute University
Charlotte, North Carolina, 28204, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57108, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Medical Oncology Associates, PS
Spokane, Washington, 99208, United States
Instituto Alexander Fleming
CABA, Buenos Aires, C1426ANZ, Argentina
Hospital Universitario Fundacion Favaloro
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS, Argentina
Sociedad de Beneficencia Hospital Italiano
Córdoba, Córdoba Province, 5000, Argentina
Hospital Privado Universitario de Cordoba
Córdoba, Córdoba Province, X5016KEH, Argentina
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS, Argentina
Exelsus Oncologia Clinica
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADT
Buenos Aires, C1122AAL, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB, Argentina
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000, Belgium
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110, Brazil
Centro de Oncologia Mackenzie
Curitiba, Paraná, 80440-220, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Clinica de Oncologia Reichow
Blumenau, Santa Catarina, 89010-340, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
Florianópolis, Santa Catarina, 88020-210, Brazil
Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
Santo André, São Paulo, 09060-650, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, 20231-050, Brazil
Hospital Nove de Julho - dasa
São Paulo, 01409-001, Brazil
Instituto Brasileiro de Controle do Cancer Ibcc
São Paulo, 04014-002, Brazil
Multiprofile Hospital for Active Treatment Park Hospital EOOD
Branipole Village, 4109, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo, 6300, Bulgaria
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
Pleven, 5800, Bulgaria
University Multiprofile Hospital for Active Treatment Pulmed OOD
Plovdiv, 4002, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, 1632, Bulgaria
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
James Lind Centro de Investigacion del Cancer
Temuco, Cautín, 4800827, Chile
Clinica CIDO
Temuco, Cautín, 4810218, Chile
Centro de Estudios Clinicos SAGA Spa
Santiago, 7500653, Chile
Centro de Estudios Clinicos e Investigaciones Medicas CeCim
Santiago, 8320000, Chile
The First Affiliated Hospital of Bengbu Medical College
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
Beijing, Beijing Municipality, 100032, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 400037, 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 Wuwei Tumour Hospital
Wuwei, Gansu, 733000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510030, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510180, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510700, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology
Wuhan, Hebei, 430030, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Anyang Cancer Hospital
Anyang, Henan, 455001, 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
The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech
Wuhan, Hubei, 430000, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, 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
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130022, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
The First Affiliated Hospital of Xi an Jiaotong University
Xi'an, Shaanxi, 710061, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 201800, China
Changzhi Peoples Hospital
Changzhi, Shanxi, 046000, China
Linfen Central Hospital
Linfen, Shanxi, 100032, China
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, 030013, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, 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
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
Peoples Hospital of Quzhou
Quzhou, Zhejiang, 324000, China
Beijing Cancer Hospital
Beijing, 100142, China
Tianjin Medical University Cancer institute and hospital
Tianjin, 300060, China
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
Instituto Cancerologico de Narino Ltda
Pasto, 520002, Colombia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Fakultni Thomayerova nemocnice
Prague, 140 59, Czechia
Rigshospitalet
Copenhagen, 2100, Denmark
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
Amiens, 80054, France
Sainte Catherine - Institut du Cancer d Avignon
Avignon, 84918, France
Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
Besançon, 25030, France
Centre Hospitalier Universitaire de Brest - Cavale Blanche
Brest, 29609, France
Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
Clermont-Ferrand, 63003, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille, 59037, France
Centre Leon Berard
Lyon, 69373, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Institut Mutualiste Montsouris
Paris, 75674, France
Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré
Reims, 51092, France
Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
Institut de cancerologie Strasbourg Europe
Strasbourg, 67065, France
Institut Gustave Roussy
Villejuif, 94805, France
Agios Savvas Anticancer Hospital
Athens, 11522, Greece
251 General Airforce Hospital
Athens, 11525, Greece
General Hospital of Athens Laiko
Athens, 11526, Greece
Evgenidio Hospital I Agia Trias
Athens, 11528, Greece
Metropolitan Hospital
Athens, 18547, Greece
University Hospital of Heraklion
Heraklion - Crete, 71500, Greece
University Hospital of Larissa
Larissa, 41110, Greece
University Hospital of Patras
Pátrai, 26504, Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, 54007, Greece
Bioclinic of Thessaloniki
Thessaloniki, 54622, Greece
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, 9024, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza, 4400, Hungary
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
St James Hospital
Dublin, 8, Ireland
St Vincents University Hospital
Dublin, D04T6F4, Ireland
Assuta Medical Center
Jerusalem, 9103102, Israel
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Istituto Ospedaliero Fondazione Poliambulanza
Brescia, 25124, Italy
Azienda Ospedaliera di Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
Catania, 95122, Italy
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce, 73100, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
Monserrato CA, 09042, Italy
Azienda Unita Saniataria Locale IRCCS di Reggio Emilia
Reggio Emilia, 42123, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Azienda Ospedaliera San Giovanni Addolorata
Roma, 00184, Italy
IRCCS Istituto Clinico Humanitas
Rozzano MI, 20089, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128, Italy
Azienda Ospedaliera Cardinale Giovanni Panico
Tricase, 73039, Italy
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
Udine, 33100, Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
Verona, 37126, Italy
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, Japan
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
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, 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
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Pauls Stradins Clinical University Hospital
Riga, 1002, Latvia
Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos
Kaunas, 50161, Lithuania
Viesoji istaiga Klaipedos universitetine ligonine
Klaipėda, 92288, Lithuania
Nacionalinis vezio institutas
Vilnius, 08660, Lithuania
Vilnius University Hospital Santaros Clinic Public Institution
Vilnius, 08661, Lithuania
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
Centro Oncologico Internacional
Tijuana, Baja California Norte, 22010, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
Zapopan, Jalisco, 45070, Mexico
Christus Muguerza Clinica Vidriera
Monterrey, Nuevo León, 64570, Mexico
Filios Alta Medicina sa de cv
Monterrey, Nuevo León, 64570, Mexico
Investigación Biomédica para el Desarrollo de Fármacos
Aguascalientes, 20010, Mexico
Trials In Medicine SC
México, 06720, Mexico
Oslo University Hospital
Oslo, 0424, Norway
Centro de Investigacion Clinica Trujillo Eirl
Trujillo, La Libertad, 13001, Peru
Instituto Peruano de Oncologia y Radioterapia
San Isidro, Lima region, 15036, Peru
Centro Medico Monte Carmelo
Arequipa, 04001, Peru
Oncosalud
Lima, 15036, Peru
Centrum Onkologii im prof Franciszka Lukaszczyka
Bydgoszcz, 85-796, Poland
Szpitale Pomorskie Spzoo
Gdynia, 81-519, Poland
Biokinetica SA
Józefów, 05-410, Poland
Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
Koszalin, 75-581, Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
Olsztyn, 10-228, Poland
SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
Opole, 45-060, Poland
Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
Poznan, 61-866, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37-700, Poland
Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal
Radom, 26-600, Poland
Unidade Local de Saude de Coimbra, EPE
Coimbra, 3004-561, Portugal
Unidade Local de Saude do Alto Ave, EPE
Guimarães, 4835-044, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
Porto, 4099-001, 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
Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
Santa Maria da Feira, 4520-211, Portugal
Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare
Baia Mare, 430031, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Bucharest, 022338, Romania
SC Medisprof SRL
Cluj-Napoca, 400058, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Ovidius Clinical Hospital
Ovidiu, 905900, Romania
National Cancer Centre Singapore
Singapore, 168583, Singapore
The Oncology Centre
Durban, 4001, South Africa
Sandton Oncology Centre
Gauteng, 2021, South Africa
Netcare Milpark Hospital
Johannesburg, 2196, South Africa
Steve Biko Academic Hospital
Pretoria, 0002, South Africa
Dong-A University Hospital
Busan, 49201, South Korea
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
The Catholic University of Korea Incheon St Marys Hospital
Incheon, 21431, 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 Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29010, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009, Spain
Hospital Donostia
Donostia / San Sebastian, Basque Country, 20014, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, 09006, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Catalonia, 08208, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, 32005, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28009, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28220, Spain
Hospital General Universitario Jose Maria Morales Meseguer
Murcia, 30008, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, 141 86, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, 01250, Turkey (Türkiye)
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 06100, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Antalya Egitim ve Arastirma Hastanesi
Antalya, 07100, Turkey (Türkiye)
Dicle Universitesi Tip Fakultesi
Diyarbakır, 21080, Turkey (Türkiye)
Bezmialem Vakif Universitesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul, 34865, Turkey (Türkiye)
Izmir Ataturk Egitim ve Arastirma Hastanesi
Izmir, 35150, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41380, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya, 44280, Turkey (Türkiye)
Sakarya Egitim ve Arastirma Hastanesi
Sakarya, 54290, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200, Turkey (Türkiye)
Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi
Van, 65000, Turkey (Türkiye)
Related Publications (4)
Rha SY, Zhang Y, Elme A, Pazo Cid R, Alacacioglu A, Ziogas DC, Shitara K, Ranceva A, Nemecek R, Santoro A, Calderon CA, Korphaisarn K, Davis T, Zahlten-Kuemeli A, Conn C, Tan M, Honeycutt H, Wainberg ZA. Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial. JCO Precis Oncol. 2025 Jan;9:e2400710. doi: 10.1200/PO-24-00710. Epub 2025 Jan 24.
PMID: 39854659BACKGROUNDFarooq AV, Kaur S, Hundal P, Burke M, Sulaiman R, Zahlten-Kumeli A, Raoof S, Li Z, Murias Dos Santos T, Huang XJ, Colby K. Advancing Ocular Safety Profile Assessment: A Novel Grading Scale for Ocular Adverse Reactions Associated with Bemarituzumab. Ophthalmol Ther. 2025 Jul;14(7):1349-1356. doi: 10.1007/s40123-025-01139-6. Epub 2025 May 12.
PMID: 40355729BACKGROUNDYu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.
PMID: 40341124DERIVEDWainberg 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)
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2021
First Posted
September 22, 2021
Study Start
March 7, 2022
Primary Completion
June 20, 2025
Study Completion
April 26, 2026
Last Updated
May 27, 2026
Record last verified: 2026-05
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.