Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101)

May 22, 2026 updated by: Amgen

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
547

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, C1122AAL
        • Instituto Argentino de Diagnostico y Tratamiento IADT
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1426ANZ
        • Instituto Alexander Fleming
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1093AAS
        • Hospital Universitario Fundacion Favaloro
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
        • Sociedad de Beneficencia Hospital Italiano
      • Córdoba, Córdoba Province, Argentina, X5016KEH
        • Hospital Privado Universitario De Cordoba
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2002KDS
        • Hospital Provincial del Centenario
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Exelsus Oncologia Clinica
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • St John of God Murdoch Hospital
  • Belgium
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional de Câncer
      • São Paulo, Brazil, 01409-001
        • Hospital Nove de Julho - dasa
      • São Paulo, Brazil, 04014-002
        • Instituto Brasileiro de Controle do Cancer Ibcc
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40170-110
        • Nucleo de Oncologia da Bahia
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-220
        • Centro de Oncologia Mackenzie
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-340
        • Clinica de Oncologia Reichow
      • Florianópolis, Santa Catarina, Brazil, 88020-210
        • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-650
        • Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
  • Bulgaria
      • Branipole Village, Bulgaria, 4109
        • Multiprofile Hospital for Active Treatment Park Hospital EOOD
      • Haskovo, Bulgaria, 6300
        • Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
      • Pleven, Bulgaria, 5800
        • University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment Pulmed OOD
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
      • Sofia, Bulgaria, 1632
        • Multiprofile Hospital for Active Treatment Serdika EOOD
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Chile
      • Santiago, Chile, 7500653
        • Centro de Estudios Clinicos SAGA Spa
      • Santiago, Chile, 8320000
        • Centro de Estudios Clinicos e Investigaciones Medicas CeCim
    • Cautín
      • Temuco, Cautín, Chile, 4800827
        • James Lind Centro de Investigacion del Cancer
      • Temuco, Cautín, Chile, 4810218
        • Clinica CIDO
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
    • Anhui
      • Bengbu, Anhui, China, 233099
        • The First Affiliated Hospital of Bengbu Medical College
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230031
        • Anhui Provincial Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital of Chinese Academy of Medical Sciences
      • Beijing, Beijing Municipality, China, 100032
        • Peking Union Medical College Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Chongqing University Three Gorges Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
      • Xiamen, Fujian, China, 361003
        • The first affiliated hospital of xiamen university
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Lanzhou University Second Hospital
      • Wuwei, Gansu, China, 733000
        • Gansu Wuwei Tumour Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510030
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510700
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510180
        • Guangdong Provincial Peoples Hospital
      • Shantou, Guangdong, China, 515031
        • Cancer Hospital of Shantou University Medical College
    • Hainan
      • Haikou, Hainan, China, 570102
        • The First Affiliated Hospital of Hainan Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Fourth Hospital of Hebei Medical University
      • Wuhan, Hebei, China, 430030
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin medical university cancer hospital
    • Henan
      • Anyang, Henan, China, 455001
        • Anyang Cancer Hospital
      • Luoyang, Henan, China, 471000
        • The first affiliated hospital of Henan University of science and technology
      • Zhengzhou, Henan, China, 450052
        • The first affiliated hospital of Zhengzhou university
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Taihe Hospital Affiliated Hospital of Hubei University of Medicine
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430000
        • The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410000
        • Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China, 214122
        • Affiliated Hospital of Jiangnan University
      • Xuzhou, Jiangsu, China, 221002
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of NanChang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130022
        • China-Japan Union Hospital of Jilin University
    • Liaoning
      • Jinzhou, Liaoning, China, 121000
        • The First Affiliated Hospital of Jinzhou Medical University
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi An JiaoTong University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
      • Jinan, Shandong, China, 250117
        • The Affiliated Cancer Hospital of Shandong First Medical University
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, Shanghai Municipality, China, 200080
        • Shanghai General Hospital
      • Shanghai, Shanghai Municipality, China, 200123
        • Shanghai East Hospital
      • Shanghai, Shanghai Municipality, China, 201321
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 201800
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Changzhi Peoples Hospital
      • Linfen, Shanxi, China, 100032
        • Linfen Central Hospital
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Province Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Linhai, Zhejiang, China, 317000
        • Taizhou Hospital of Zhejiang Province
      • Lishui, Zhejiang, China, 323000
        • Lishui Municipal Central Hospital
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliate Hospital of Ningbo University
      • Quzhou, Zhejiang, China, 324000
        • Peoples Hospital of Quzhou
  • Colombia
      • Pasto, Colombia, 520002
        • Instituto Cancerologico de Narino Ltda
    • Antioquia
      • Rionegro, Antioquia, Colombia, 054040
        • Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Sociedad de Oncologia y Hematologia del Cesar
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 681017
        • Fundacion Cardiovascular de Colombia
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv onkologicky ustav
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc
      • Prague, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia, 140 59
        • Fakultni Thomayerova nemocnice
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation
  • France
      • Amiens, France, 80054
        • Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
      • Avignon, France, 84918
        • Sainte Catherine - Institut du Cancer d Avignon
      • Besançon, France, 25030
        • Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
      • Brest, France, 29609
        • Centre Hospitalier Universitaire de Brest - Cavale Blanche
      • Clermont-Ferrand, France, 63003
        • Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
      • Lille, France, 59037
        • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75674
        • Institut Mutualiste Montsouris
      • Reims, France, 51092
        • Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré
      • Saint-Priest-en-Jarez, France, 42270
        • Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
      • Strasbourg, France, 67065
        • Institut de cancérologie Strasbourg Europe
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Greece
      • Athens, Greece, 18547
        • Metropolitan Hospital
      • Athens, Greece, 11525
        • 251 General Airforce Hospital
      • Athens, Greece, 11522
        • Agios Savvas Anticancer Hospital
      • Athens, Greece, 11528
        • Evgenidio Hospital I Agia Trias
      • Athens, Greece, 11526
        • General Hospital of Athens Laiko
      • Heraklion - Crete, Greece, 71500
        • University Hospital of Heraklion
      • Larissa, Greece, 41110
        • University Hospital Of Larissa
      • Pátrai, Greece, 26504
        • University Hospital of Patras
      • Thessaloniki, Greece, 54622
        • Bioclinic of Thessaloniki
      • Thessaloniki, Greece, 54007
        • Anticancer Hospital of Thessaloniki Theageneio
  • Hungary
      • Gyula, Hungary, 5700
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Győr, Hungary, 9024
        • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
      • Miskolc, Hungary, 3526
        • Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
      • Nyíregyháza, Hungary, 4400
        • Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház
      • Szekszárd, Hungary, 7100
        • Tolna Varmegyei Balassa Janos Korhaz
  • Ireland
      • Dublin, Ireland, 8
        • St James Hospital
      • Dublin, Ireland, D04T6F4
        • St Vincents University Hospital
  • Israel
      • Jerusalem, Israel, 9103102
        • Assuta Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Ein-Kerem Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
  • Italy
      • Brescia, Italy, 25124
        • Istituto Ospedaliero Fondazione Poliambulanza
      • Catania, Italy, 95122
        • Azienda Ospedaliera di Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
      • Lecce, Italy, 73100
        • Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
      • Milan, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Monserrato CA, Italy, 09042
        • Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
      • Reggio Emilia, Italy, 42123
        • Azienda Unita Saniataria Locale IRCCS di Reggio Emilia
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italy, 00184
        • Azienda Ospedaliera San Giovanni Addolorata
      • Rozzano MI, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
      • Torino, Italy, 10128
        • Azienda Ospedaliera Ordine Mauriziano di Torino
      • Tricase, Italy, 73039
        • Azienda Ospedaliera Cardinale Giovanni Panico
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Nagoya University Hospital
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Chiba Cancer Center
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
    • Gifu
      • Gifu, Gifu, Japan, 501-1194
        • Gifu University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan, 673-8558
        • Hyogo Cancer Center
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8530
        • Ishikawa Prefectural Central Hospital
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Kagawa University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
    • Niigata
      • Niigata, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Osaka, Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Saitama Cancer Center
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos
      • Klaipėda, Lithuania, 92288
        • Viesoji istaiga Klaipedos universitetine ligonine
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Clinic Public Institution
      • Vilnius, Lithuania, 08660
        • Nacionalinis vezio institutas
  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital
  • Mexico
      • Aguascalientes, Mexico, 20010
        • Investigación Biomédica para el Desarrollo de Fármacos
      • México, Mexico, 06720
        • Trials In Medicine SC
    • Baja California Norte
      • Tijuana, Baja California Norte, Mexico, 22010
        • Centro Oncologico Internacional
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Zapopan, Jalisco, Mexico, 45070
        • Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64570
        • Christus Muguerza Clinica Vidriera
      • Monterrey, Nuevo León, Mexico, 64570
        • Filios Alta Medicina sa de cv
  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital
  • Peru
      • Arequipa, Peru, 04001
        • Centro Medico Monte Carmelo
      • Lima, Peru, 15036
        • Oncosalud
    • La Libertad
      • Trujillo, La Libertad, Peru, 13001
        • Centro de Investigacion Clinica Trujillo Eirl
    • Lima region
      • San Isidro, Lima region, Peru, 15036
        • Instituto Peruano de Oncología y Radioterapia
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Centrum Onkologii im prof Franciszka Lukaszczyka
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Spzoo
      • Józefów, Poland, 05-410
        • Biokinetica SA
      • Koszalin, Poland, 75-581
        • Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
      • Olsztyn, Poland, 10-228
        • Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
      • Opole, Poland, 45-060
        • SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
      • Poznan, Poland, 61-866
        • Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
      • Przemyśl, Poland, 37-700
        • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
      • Radom, Poland, 26-600
        • Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Unidade Local de Saude de Coimbra, EPE
      • Guimarães, Portugal, 4835-044
        • Unidade Local de Saude do Alto Ave, EPE
      • Lisbon, Portugal, 1649-035
        • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
      • Porto, Portugal, 4099-001
        • Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
      • Porto, Portugal, 4200-319
        • Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
      • Santa Maria da Feira, Portugal, 4520-211
        • Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
  • Romania
      • Baia Mare, Romania, 430031
        • Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare
      • Bucharest, Romania, 022328
        • Institutul Clinic Fundeni
      • Bucharest, Romania, 022338
        • Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
      • Cluj-Napoca, Romania, 400058
        • SC Medisprof SRL
      • Iași, Romania, 700483
        • Institutul Regional de Oncologie Iasi
      • Ovidiu, Romania, 905900
        • Ovidius Clinical Hospital
  • Singapore
      • Singapore, Singapore, 168583
        • National Cancer Centre Singapore
  • South Africa
      • Durban, South Africa, 4001
        • The Oncology Centre
      • Gauteng, South Africa, 2021
        • Sandton Oncology Centre
      • Johannesburg, South Africa, 2196
        • Netcare Milpark Hospital
      • Pretoria, South Africa, 0002
        • Steve Biko Academic Hospital
  • South Korea
      • Busan, South Korea, 49201
        • Dong-A University Hospital
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Daejeon, South Korea, 35015
        • Chungnam national university hospital
      • Goyang-si Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Incheon, South Korea, 21431
        • The Catholic University of Korea Incheon St Marys Hospital
      • Jeonju-si, Jeollabuk-do, South Korea, 54907
        • Jeonbuk National University Hospital
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
  • Spain
      • Madrid, Spain, 28220
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañon
      • Murcia, Spain, 30008
        • Hospital General Universitario Jose Maria Morales Meseguer
    • Andalusia
      • Córdoba, Andalusia, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Málaga, Andalusia, Spain, 29010
        • Hospital Regional Universitario de Malaga
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Basque Country
      • Donostia / San Sebastian, Basque Country, Spain, 20014
        • Hospital Donostia
    • Castille and León
      • Burgos, Castille and León, Spain, 09006
        • Hospital Universitario de Burgos
    • Catalonia
      • Barcelona, Catalonia, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Catalonia, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Sabadell, Catalonia, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
    • Galicia
      • Ourense, Galicia, Spain, 32005
        • Complexo Hospitalario Universitario de Ourense
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
      • Stockholm, Sweden, 141 86
        • Karolinska Universitetssjukhuset Huddinge
      • Umeå, Sweden, 901 85
        • Norrlands Universitetssjukhus
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
      • Ankara, Turkey (Türkiye), 06520
        • Memorial Ankara Hastanesi
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent Sehir Hastanesi
      • Ankara, Turkey (Türkiye), 06100
        • Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Antalya, Turkey (Türkiye), 07100
        • Antalya Egitim ve Arastirma Hastanesi
      • Diyarbakır, Turkey (Türkiye), 21080
        • Dicle Universitesi Tip Fakultesi
      • Istanbul, Turkey (Türkiye), 34722
        • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
      • Istanbul, Turkey (Türkiye), 34865
        • Kartal Dr Lutfi Kirdar sehir Hastanesi
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Istanbul, Turkey (Türkiye), 34093
        • Bezmialem Vakif Universitesi Hastanesi
      • Izmir, Turkey (Türkiye), 35150
        • Izmir Ataturk Egitim ve Arastirma Hastanesi
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi Hastanesi
      • Malatya, Turkey (Türkiye), 44280
        • Inonu Universitesi Turgut Ozal Tip Merkezi
      • Sakarya, Turkey (Türkiye), 54290
        • Sakarya Egitim ve Arastirma Hastanesi
      • Samsun, Turkey (Türkiye), 55200
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
      • Van, Turkey (Türkiye), 65000
        • Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Cerritos, California, United States, 90703
        • The Oncology Institute Clinical Research
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Saint Francis Medical Group
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New York
      • Brooklyn, New York, United States, 11220
        • Healthier Hematology and Oncology Excelsior Integrated Medical Group
      • White Plains, New York, United States, 10601
        • White Plains Hospital Center for Cancer Care
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute University
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Avera Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
    • Washington
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates, PS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bemarituzumab with mFOLFOX6
Drug: Bemarituzumab
Intravenous (IV) infusion
Drug: mFOLFOX6
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
Active Comparator: Placebo with mFOLFOX6
Drug: Placebo
IV infusion
Drug: mFOLFOX6
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to approximately 3.5 years
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Up to approximately 3.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to approximately 3.5 years
Overall survival in all randomized participants
Up to approximately 3.5 years
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Time Frame: Day 1 up to approximately 3.5 years
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
Time Frame: Day 1 up to approximately 3.5 years
Day 1 up to approximately 3.5 years
Number of Participants with an Anti-bemarituzumab Antibody Formation
Time Frame: Day 1 up to approximately 3.5 years
Day 1 up to approximately 3.5 years
Progression-free Survival (PFS)
Time Frame: Up to approximately 3.5 years
PFS in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Up to approximately 3.5 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 3.5 years
ORR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Up to approximately 3.5 years
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Time Frame: Up to approximately 3.5 years
Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests after first dose will be recorded as TEAEs.
Up to approximately 3.5 years
Progression-free Survival (PFS)
Time Frame: Up to approximately 3.5 years
PFS in all randomized participants
Up to approximately 3.5 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 3.5 years
ORR in all randomized participants
Up to approximately 3.5 years
Duration of Response (DOR)
Time Frame: Up to approximately 3.5 years
DOR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Up to approximately 3.5 years
Disease Control Rate
Time Frame: Up to approximately 3.5 years
Disease Control Rate in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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)
Time Frame: Up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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)
Time Frame: Baseline up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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)
Time Frame: Up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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)
Time Frame: Baseline up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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)
Time Frame: Up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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)
Time Frame: Baseline up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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)
Time Frame: Up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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
Time Frame: Up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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
Time Frame: Up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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)
Time Frame: Day 1 up to approximately 3.5 years
Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
Day 1 up to approximately 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zai Lab (China only)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20210096
  • 2023-505457-40 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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