Gastric CancerPhase 3FORTITUDE-101NCT05052801
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
A Phase 3 study testing Bemarituzumab and mFOLFOX6 in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Amgen at 300 sites in 37 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Bemarituzumab and mFOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 547 participants
- Where
- 300 sitesin 37 countries
- Study dates
- 7 Mar 2022to 26 Apr 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
300 sites in 37 countries.
300 sites in 37 countries
China60 sites
Anyang Cancer Hospital
Anyang, Henan, 455001
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Beijing Cancer Hospital
Beijing, 100142
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233099
The First Hospital of Jilin University
Changchun, Jilin, 130021
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130022
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Hunan Cancer Hospital
Changsha, Hunan, 410013
Changzhi Peoples Hospital
Changzhi, Shanxi, 046000
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 400037
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510030
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510180
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510700
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
Jinan Central Hospital
Jinan, Shandong, 250013
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Linfen Central Hospital
Linfen, Shanxi, 100032
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000
Lishui Municipal central Hospital
Lishui, Zhejiang, 323000
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, 471000
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Nanjing First Hospital
Nanjing, Jiangsu, 210006
The First Affiliate Hospital of Ningbo University
Ningbo, Zhejiang, 315010
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Peoples Hospital of Quzhou
Quzhou, Zhejiang, 324000
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 201800
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, 442000
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, 030013
Tianjin Medical University Cancer institute and hospital
Tianjin, 300060
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology
Wuhan, Hebei, 430030
The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech
Wuhan, Hubei, 430000
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733000
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122
The First Affiliated Hospital of Xi an Jiaotong University
Xi'an, Shaanxi, 710061
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Henan Cancer Hospital
Zhengzhou, Henan, 450000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Japan24 sites
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558
Chiba Cancer Center
Chiba, Chiba, 260-8717
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
Gifu University Hospital
Gifu, Gifu, 501-1194
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Osaka University Hospital
Suita-shi, Osaka, 565-0871
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Turkey (Türkiye)17 sites
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, 01250
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 06100
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230
Memorial Ankara Hastanesi
Ankara, 06520
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
Antalya Egitim ve Arastirma Hastanesi
Antalya, 07100
Dicle Universitesi Tip Fakultesi
Diyarbakır, 21080
Bezmialem Vakif Universitesi Hastanesi
Istanbul, 34093
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul, 34865
Izmir Ataturk Egitim ve Arastirma Hastanesi
Izmir, 35150
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41380
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya, 44280
Sakarya Egitim ve Arastirma Hastanesi
Sakarya, 54290
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200
Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi
Van, 65000
United States16 sites
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
University of Michigan
Ann Arbor, Michigan, 48109
Healthier Hematology and Oncology Excelsior Integrated Medical Group
Brooklyn, New York, 11220
The Oncology Institute Clinical Research
Cerritos, California, 90703
Levine Cancer Institute University
Charlotte, North Carolina, 28204
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Saint Francis Medical Group
Indianapolis, Indiana, 46237
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of California Los Angeles
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mayo Clinic Arizona
Phoenix, Arizona, 85054
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Avera Cancer Institute
Sioux Falls, South Dakota, 57108
Medical Oncology Associates, PS
Spokane, Washington, 99208
White Plains Hospital Center for Cancer Care
White Plains, New York, 10601
South Korea15 sites
Dong-A University Hospital
Busan, 49201
Kyungpook National University Chilgok Hospital
Daegu, 41404
Chungnam National University Hospital
Daejeon, 35015
National Cancer Center
Goyang-si Gyeonggi-do, 10408
The Catholic University of Korea Incheon St Marys Hospital
Incheon, 21431
Jeonbuk National University Hospital
Jeonju-si, Jeollabuk-do, 54907
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Severance Hospital Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Korea University Guro Hospital
Seoul, 08308
France13 sites
Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
Amiens, 80054
Sainte Catherine - Institut du Cancer d Avignon
Avignon, 84918
Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
Besançon, 25030
Centre Hospitalier Universitaire de Brest - Cavale Blanche
Brest, 29609
Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
Clermont-Ferrand, 63003
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille, 59037
Centre Leon Berard
Lyon, 69373
Hôpital Européen Georges Pompidou
Paris, 75015
Institut Mutualiste Montsouris
Paris, 75674
Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré
Reims, 51092
Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270
Institut de cancerologie Strasbourg Europe
Strasbourg, 67065
Institut Gustave Roussy
Villejuif, 94805
Italy13 sites
Istituto Ospedaliero Fondazione Poliambulanza
Brescia, 25124
Azienda Ospedaliera di Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
Catania, 95122
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce, 73100
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
Monserrato CA, 09042
Azienda Unita Saniataria Locale IRCCS di Reggio Emilia
Reggio Emilia, 42123
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Azienda Ospedaliera San Giovanni Addolorata
Roma, 00184
IRCCS Istituto Clinico Humanitas
Rozzano MI, 20089
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128
Azienda Ospedaliera Cardinale Giovanni Panico
Tricase, 73039
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
Udine, 33100
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
Verona, 37126
Spain13 sites
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Hospital Universitario de Burgos
Burgos, Castille and León, 09006
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004
Hospital Donostia
Donostia / San Sebastian, Basque Country, 20014
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28220
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29010
Hospital General Universitario Jose Maria Morales Meseguer
Murcia, 30008
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, 32005
Corporacio Sanitaria Parc Tauli
Sabadell, Catalonia, 08208
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009
Brazil10 sites
Clinica de Oncologia Reichow
Blumenau, Santa Catarina, 89010-340
Centro de Oncologia Mackenzie
Curitiba, Paraná, 80440-220
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
Florianópolis, Santa Catarina, 88020-210
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
Instituto Nacional de Cancer
Rio de Janeiro, 20231-050
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110
Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
Santo André, São Paulo, 09060-650
Hospital Nove de Julho - dasa
São Paulo, 01409-001
Instituto Brasileiro de Controle do Cancer Ibcc
São Paulo, 04014-002
Greece10 sites
Agios Savvas Anticancer Hospital
Athens, 11522
251 General Airforce Hospital
Athens, 11525
General Hospital of Athens Laiko
Athens, 11526
Evgenidio Hospital I Agia Trias
Athens, 11528
Metropolitan Hospital
Athens, 18547
University Hospital of Heraklion
Heraklion - Crete, 71500
University Hospital of Larissa
Larissa, 41110
University Hospital of Patras
Pátrai, 26504
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, 54007
Bioclinic of Thessaloniki
Thessaloniki, 54622
Poland9 sites
Centrum Onkologii im prof Franciszka Lukaszczyka
Bydgoszcz, 85-796
Szpitale Pomorskie Spzoo
Gdynia, 81-519
Biokinetica SA
Józefów, 05-410
Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
Koszalin, 75-581
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
Olsztyn, 10-228
SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
Opole, 45-060
Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
Poznan, 61-866
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37-700
Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal
Radom, 26-600
Argentina8 sites
Instituto Argentino de Diagnostico y Tratamiento IADT
Buenos Aires, C1122AAL
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB
Instituto Alexander Fleming
CABA, Buenos Aires, C1426ANZ
Hospital Universitario Fundacion Favaloro
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS
Sociedad de Beneficencia Hospital Italiano
Córdoba, Córdoba Province, 5000
Hospital Privado Universitario de Cordoba
Córdoba, Córdoba Province, X5016KEH
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS
Exelsus Oncologia Clinica
San Miguel de Tucumán, Tucumán Province, 4000
Mexico7 sites
Investigación Biomédica para el Desarrollo de Fármacos
Aguascalientes, 20010
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Trials In Medicine SC
México, 06720
Christus Muguerza Clinica Vidriera
Monterrey, Nuevo León, 64570
Filios Alta Medicina sa de cv
Monterrey, Nuevo León, 64570
Centro Oncologico Internacional
Tijuana, Baja California Norte, 22010
Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
Zapopan, Jalisco, 45070
Portugal7 sites
Unidade Local de Saude de Coimbra, EPE
Coimbra, 3004-561
Unidade Local de Saude do Alto Ave, EPE
Guimarães, 4835-044
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
Porto, 4099-001
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, 4200-319
Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
Santa Maria da Feira, 4520-211
Bulgaria6 sites
Multiprofile Hospital for Active Treatment Park Hospital EOOD
Branipole Village, 4109
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo, 6300
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
Pleven, 5800
University Multiprofile Hospital for Active Treatment Pulmed OOD
Plovdiv, 4002
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, 1632
Romania6 sites
Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare
Baia Mare, 430031
Institutul Clinic Fundeni
Bucharest, 022328
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Bucharest, 022338
SC Medisprof SRL
Cluj-Napoca, 400058
Institutul Regional de Oncologie Iasi
Iași, 700483
Ovidius Clinical Hospital
Ovidiu, 905900
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 70403
Tri-Service General Hospital
Taipei, 11490
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305
Czechia5 sites
Masarykuv onkologicky ustav
Brno, 656 53
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni nemocnice Olomouc
Olomouc, 779 00
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Fakultni Thomayerova nemocnice
Prague, 140 59
Hungary5 sites
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, 9024
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza, 4400
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100
Belgium4 sites
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000
Canada4 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Jewish General Hospital
Montreal, Quebec, H3T 1E2
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Chile4 sites
Centro de Estudios Clinicos SAGA Spa
Santiago, 7500653
Centro de Estudios Clinicos e Investigaciones Medicas CeCim
Santiago, 8320000
James Lind Centro de Investigacion del Cancer
Temuco, Cautín, 4800827
Clinica CIDO
Temuco, Cautín, 4810218
Colombia4 sites
Fundacion Cardiovascular de Colombia
Bucaramanga, Santander Department, 681017
Instituto Cancerologico de Narino Ltda
Pasto, 520002
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
Rionegro, Antioquia, 054040
Sociedad de Oncologia y Hematologia del Cesar
Valledupar, Cesar Department, 200001
Lithuania4 sites
Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos
Kaunas, 50161
Viesoji istaiga Klaipedos universitetine ligonine
Klaipėda, 92288
Nacionalinis vezio institutas
Vilnius, 08660
Vilnius University Hospital Santaros Clinic Public Institution
Vilnius, 08661
Peru4 sites
Centro Medico Monte Carmelo
Arequipa, 04001
Oncosalud
Lima, 15036
Instituto Peruano de Oncologia y Radioterapia
San Isidro, Lima region, 15036
Centro de Investigacion Clinica Trujillo Eirl
Trujillo, La Libertad, 13001
South Africa4 sites
The Oncology Centre
Durban, 4001
Sandton Oncology Centre
Gauteng, 2021
Netcare Milpark Hospital
Johannesburg, 2196
Steve Biko Academic Hospital
Pretoria, 0002
Thailand4 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Rajavithi Hospital
Bangkok, 10400
Ramathibodi Hospital
Bangkok, 10400
Siriraj Hospital
Bangkok, 10700
Israel3 sites
Assuta Medical Center
Jerusalem, 9103102
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
Malaysia3 sites
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Sarawak General Hospital
Kuching, Sarawak, 93586
Sweden3 sites
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Karolinska Universitetssjukhuset Huddinge
Stockholm, 141 86
Norrlands Universitetssjukhus
Umeå, 901 85
Australia2 sites
Liverpool Hospital
Liverpool, New South Wales, 2170
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150
Ireland2 sites
St James Hospital
Dublin, 8
St Vincents University Hospital
Dublin, D04T6F4
About this study
Official title: 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
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)
- Being tested
- Bemarituzumab, mFOLFOX6, Placebo
- Keywords
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Bemarituzumab, FGFR2b Overexpression
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemarituzumabDrug
Intravenous (IV) infusion
mFOLFOX6Drug
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
PlaceboDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Bemarituzumab with mFOLFOX6 | Experimental | Not described Receives: Drug: Bemarituzumab; Drug: mFOLFOX6 |
| Placebo with mFOLFOX6 | Active comparator | Not described Receives: Drug: mFOLFOX6; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Secondary outcomes (21)
Progression-free Survival (PFS)
PFS in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Objective Response Rate (ORR)
ORR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests after first dose will be recorded as TEAEs.
Measured: Up to approximately 3.5 years
Overall Survival
Overall survival in all randomized participants
Measured: Up to approximately 3.5 years
Progression-free Survival (PFS)
PFS in all randomized participants
Measured: Up to approximately 3.5 years
Objective Response Rate (ORR)
ORR in all randomized participants
Measured: Up to approximately 3.5 years
Duration of Response (DOR)
DOR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Disease Control Rate
Disease Control Rate in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Baseline up to approximately 3.5 years
Stomach Cancer Related Symptom Mean Subjective Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Baseline up to approximately 3.5 years
Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Baseline up to approximately 3.5 years
Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Up to approximately 3.5 years
Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Measured: Day 1 up to approximately 3.5 years
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Measured: Day 1 up to approximately 3.5 years
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Measured: Day 1 up to approximately 3.5 years
Number of Participants with an Anti-bemarituzumab Antibody Formation
Measured: Day 1 up to approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start7 Mar 2022
- Primary completion20 Jun 2025
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (China only)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052801
- Sponsor's protocol ID
- 20210096
- Other IDs
- 2023-505457-40, 2023
- Acronym
- FORTITUDE-101
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
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.
PubMed 39854659Farooq 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.
PubMed 40355729Yu 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.
PubMed 40341124Wainberg 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.
PubMed 38308771