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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

547

Participants

Timeline

Start Date

March 7, 2022

Primary Completion Date

June 20, 2025

Study Completion Date

June 20, 2026

Conditions
Gastric CancerGastroesophageal Junction Adenocarcinoma
Interventions
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.

DRUG

Placebo

IV infusion

Trial Locations (300)

8

St James Hospital, Dublin

1002

Pauls Stradins Clinical University Hospital, Riga

1407

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia

1632

Multiprofile Hospital for Active Treatment Serdika EOOD, Sofia

2021

Sandton Oncology Centre, Gauteng

2100

Rigshospitalet, Copenhagen

2170

Liverpool Hospital, Liverpool

2196

Netcare Milpark Hospital, Johannesburg

2650

Universitair Ziekenhuis Antwerpen, Edegem

3000

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

3526

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Miskolc

4000

Exelsus Oncologia Clinica, San Miguel de Tucumán

Centre Hospitalier Universitaire de Liege - Sart Tilman, Liège

4001

The Oncology Centre, Durban

4002

University Multiprofile Hospital for Active Treatment Pulmed OOD, Plovdiv

4109

Multiprofile Hospital for Active Treatment Park Hospital EOOD, Branipole Village

4400

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz, Nyíregyháza

5000

Sociedad de Beneficencia Hospital Italiano, Córdoba

5700

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Gyula

5800

University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD, Pleven

6150

St John of God Murdoch Hospital, Murdoch

6300

Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD, Haskovo

7100

Tolna Varmegyei Balassa Janos Korhaz, Szekszárd

9000

Universitair Ziekenhuis Gent, Ghent

9024

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz, Győr

10128

Azienda Ospedaliera Ordine Mauriziano di Torino, Torino

10330

King Chulalongkorn Memorial Hospital, Bangkok

10400

Rajavithi Hospital, Bangkok

Ramathibodi Hospital, Bangkok

10408

National Cancer Center, Goyang-si Gyeonggi-do

10601

White Plains Hospital Center for Cancer Care, White Plains

10700

Siriraj Hospital, Bangkok

11220

Healthier Hematology and Oncology Excelsior Integrated Medical Group, Brooklyn

11490

Tri-Service General Hospital, Taipei

11522

Agios Savvas Anticancer Hospital, Athens

11525

251 General Airforce Hospital, Athens

11526

General Hospital of Athens Laiko, Athens

11528

Evgenidio Hospital I Agia Trias, Athens

13001

Centro de Investigacion Clinica Trujillo Eirl, Trujillo

13419

North Estonia Medical Centre Foundation, Tallinn

13620

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do

14004

Hospital Universitario Reina Sofia, Córdoba

15036

Instituto Peruano de Oncologia y Radioterapia, San Isidro

Oncosalud, Lima

18547

Metropolitan Hospital, Athens

20010

Investigación Biomédica para el Desarrollo de Fármacos, Aguascalientes

20014

Hospital Donostia, Donostia / San Sebastian

20089

IRCCS Istituto Clinico Humanitas, Rozzano MI

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

21080

Dicle Universitesi Tip Fakultesi, Diyarbakır

21431

The Catholic University of Korea Incheon St Marys Hospital, Incheon

22010

Centro Oncologico Internacional, Tijuana

22031

Inova Schar Cancer Institute, Fairfax

25030

Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz, Besançon

25124

Istituto Ospedaliero Fondazione Poliambulanza, Brescia

26504

University Hospital of Patras, Pátrai

28009

Hospital General Universitario Gregorio Marañon, Madrid

28204

Levine Cancer Institute University, Charlotte

28220

Hospital Universitario Puerta de Hierro Majadahonda, Madrid

28374

FirstHealth Cancer Center, Pinehurst

29010

Hospital Regional Universitario de Malaga, Málaga

29609

Centre Hospitalier Universitaire de Brest - Cavale Blanche, Brest

30008

Hospital General Universitario Jose Maria Morales Meseguer, Murcia

32005

Complexo Hospitalario Universitario de Ourense, Ourense

32224

Mayo Clinic Florida, Jacksonville

33100

Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia, Udine

33305

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation, Taoyuan District

34093

Bezmialem Vakif Universitesi Hastanesi, Istanbul

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul

34722

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul

34865

Kartal Dr Lutfi Kirdar Sehir Hastanesi, Istanbul

35015

Chungnam National University Hospital, Daejeon

35150

Izmir Ataturk Egitim ve Arastirma Hastanesi, Izmir

37126

Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento, Verona

37232

Vanderbilt University Medical Center, Nashville

40447

China Medical University Hospital, Taichung

41110

University Hospital of Larissa, Larissa

41380

Kocaeli Universitesi Tip Fakultesi Hastanesi, Kocaeli

41404

Kyungpook National University Chilgok Hospital, Daegu

42123

Azienda Unita Saniataria Locale IRCCS di Reggio Emilia, Reggio Emilia

42270

Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord, Saint-Priest-en-Jarez

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

Inonu Universitesi Turgut Ozal Tip Merkezi, Malatya

45070

Investigacion Biomedica para el Desarrollo de Farmacos SA de CV, Zapopan

46026

Hospital Universitari i Politecnic La Fe, Valencia

46237

Saint Francis Medical Group, Indianapolis

48109

University of Michigan, Ann Arbor

49201

Dong-A University Hospital, Busan

50009

Hospital Universitario Miguel Servet, Zaragoza

50161

Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos, Kaunas

50586

Hospital Kuala Lumpur, Kuala Lumpur

51092

Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré, Reims

54007

Anticancer Hospital of Thessaloniki Theageneio, Thessaloniki

54290

Sakarya Egitim ve Arastirma Hastanesi, Sakarya

54622

Bioclinic of Thessaloniki, Thessaloniki

54907

Jeonbuk National University Hospital, Jeonju-si, Jeollabuk-do

55200

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun

55905

Mayo Clinic Rochester, Rochester

57108

Avera Cancer Institute, Sioux Falls

59037

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez, Lille

59100

University Malaya Medical Centre, Kuala Lumpur

63003

Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing, Clermont-Ferrand

64570

Christus Muguerza Clinica Vidriera, Monterrey

Filios Alta Medicina sa de cv, Monterrey

65000

Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi, Van

67065

Institut de cancerologie Strasbourg Europe, Strasbourg

69373

Centre Leon Berard, Lyon

70403

National Cheng Kung University Hospital, Tainan City

71500

University Hospital of Heraklion, Heraklion - Crete

73039

Azienda Ospedaliera Cardinale Giovanni Panico, Tricase

73100

Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II, Lecce

75015

Hôpital Européen Georges Pompidou, Paris

75674

Institut Mutualiste Montsouris, Paris

80054

Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud, Amiens

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

84918

Sainte Catherine - Institut du Cancer d Avignon, Avignon

85054

Mayo Clinic Arizona, Phoenix

90095

University of California Los Angeles, Los Angeles

90703

The Oncology Institute Clinical Research, Cerritos

92288

Viesoji istaiga Klaipedos universitetine ligonine, Klaipėda

93586

Sarawak General Hospital, Kuching

94805

Institut Gustave Roussy, Villejuif

95122

Azienda Ospedaliera di Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima, Catania

99208

Medical Oncology Associates, PS, Spokane

99508

Alaska Oncology and Hematology, Anchorage

100021

Cancer Hospital of Chinese Academy of Medical Sciences, Beijing

100032

Peking Union Medical College Hospital, Beijing

Linfen Central Hospital, Linfen

100142

Beijing Cancer Hospital, Beijing

110001

The First Hospital of China Medical University, Shenyang

110042

Liaoning Cancer Hospital, Shenyang

121000

The First Affiliated Hospital of Jinzhou Medical University, Jinzhou

130021

The First Hospital of Jilin University, Changchun

130022

China-Japan Union Hospital of Jilin University, Changchun

150000

Harbin Medical University Cancer Hospital, Harbin

168583

National Cancer Centre Singapore, Singapore

200001

Sociedad de Oncologia y Hematologia del Cesar, Valledupar

200032

Zhongshan Hospital Fudan University, Shanghai

200080

Shanghai General Hospital, Shanghai

200123

Shanghai East Hospital, Shanghai

201321

Fudan University Shanghai Cancer Center, Shanghai

201800

Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai

210006

Nanjing First Hospital, Nanjing

214122

Affiliated Hospital of Jiangnan University, Wuxi

215004

The Second Affiliated Hospital of Soochow University, Suzhou

221002

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

230031

Anhui Provincial Cancer Hospital, Hefei

233099

The First Affiliated Hospital of Bengbu Medical College, Bengbu

250013

Jinan Central Hospital, Jinan

250117

The Affiliated Cancer Hospital of Shandong First Medical University, Jinan

266000

The Affiliated Hospital of Qingdao University, Qingdao

300060

Tianjin Medical University Cancer institute and hospital, Tianjin

310003

The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

310009

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

310016

Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou

315010

The First Affiliate Hospital of Ningbo University, Ningbo

317000

Taizhou Hospital of Zhejiang Province, Linhai

323000

Lishui Municipal central Hospital, Lishui

324000

Peoples Hospital of Quzhou, Quzhou

330006

The First Affiliated Hospital of Nanchang University, Nanchang

350001

Fujian Medical University Union Hospital, Fuzhou

350014

Fujian Cancer Hospital, Fuzhou

361003

The First Affiliated Hospital of Xiamen University, Xiamen

400037

Chongqing University Three Gorges Hospital, Chongqing

400058

SC Medisprof SRL, Cluj-Napoca

410000

Xiangya Hospital of Central South University, Changsha

410013

Hunan Cancer Hospital, Changsha

430000

The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech, Wuhan

430030

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology, Wuhan

430031

Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare, Baia Mare

430079

Hubei Cancer Hospital, Wuhan

442000

Taihe Hospital Affiliated Hospital of Hubei University of Medicine, Shiyan

450000

Henan Cancer Hospital, Zhengzhou

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

455001

Anyang Cancer Hospital, Anyang

471000

The First Affiliated Hospital of Henan University of science and Technology, Luoyang

510030

Sun Yat-sen University Cancer Center, Guangzhou

510180

Guangdong Provincial Peoples Hospital, Guangzhou

510700

Sun Yat-sen University Cancer Center, Guangzhou

515031

Cancer Hospital of Shantou University Medical College, Shantou

520002

Instituto Cancerologico de Narino Ltda, Pasto

570102

The First Affiliated Hospital of Hainan Medical University, Haikou

610041

Sichuan Cancer Hospital, Chengdu

681017

Fundacion Cardiovascular de Colombia, Bucaramanga

700483

Institutul Regional de Oncologie Iasi, Iași

710061

The First Affiliated Hospital of Xi an Jiaotong University, Xi'an

730030

Lanzhou University Second Hospital, Lanzhou

733000

Gansu Wuwei Tumour Hospital, Wuwei

905900

Ovidius Clinical Hospital, Ovidiu

4428164

Meir Medical Center, Kfar Saba

4800827

James Lind Centro de Investigacion del Cancer, Temuco

4810218

Clinica CIDO, Temuco

7500653

Centro de Estudios Clinicos SAGA Spa, Santiago

8320000

Centro de Estudios Clinicos e Investigaciones Medicas CeCim, Santiago

9103102

Assuta Medical Center, Jerusalem

9112001

Hadassah Ein-Kerem Medical Center, Jerusalem

C1426ANZ

Instituto Alexander Fleming, CABA

C1093AAS

Hospital Universitario Fundacion Favaloro, Ciudad Autonoma de Buenos Aires

X5016KEH

Hospital Privado Universitario de Cordoba, Córdoba

S2002KDS

Hospital Provincial del Centenario, Rosario

C1122AAL

Instituto Argentino de Diagnostico y Tratamiento IADT, Buenos Aires

C1280AEB

Hospital Britanico de Buenos Aires, Buenos Aires

40170-110

Núcleo de Oncologia da Bahia, Salvador

80440-220

Centro de Oncologia Mackenzie, Curitiba

98700-000

Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda, Ijuí

90610-000

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre

89010-340

Clinica de Oncologia Reichow, Blumenau

88020-210

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina, Florianópolis

09060-650

Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas, Santo André

20231-050

Instituto Nacional de Cancer, Rio de Janeiro

01409-001

Hospital Nove de Julho - dasa, São Paulo

04014-002

Instituto Brasileiro de Controle do Cancer Ibcc, São Paulo

T6G 1Z2

Cross Cancer Institute, Edmonton

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Research Institute Sunnybrook Health Sciences Centre, Toronto

H3T 1E2

Jewish General Hospital, Montreal

050011

Fourth Hospital of Hebei Medical University, Shijiazhuang

046000

Changzhi Peoples Hospital, Changzhi

030013

Shanxi Province Cancer Hospital, Taiyuan

054040

Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA, Rionegro

656 53

Masarykuv onkologicky ustav, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

779 00

Fakultni nemocnice Olomouc, Olomouc

128 08

Vseobecna fakultni nemocnice v Praze, Prague

140 59

Fakultni Thomayerova nemocnice, Prague

D04T6F4

St Vincents University Hospital, Dublin

09042

Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula, Monserrato CA

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

00184

Azienda Ospedaliera San Giovanni Addolorata, Roma

464-8681

Aichi Cancer Center, Nagoya

466-8560

Nagoya University Hospital, Nagoya

260-8717

Chiba Cancer Center, Chiba

277-8577

National Cancer Center Hospital East, Kashiwa-shi

791-0280

National Hospital Organization Shikoku Cancer Center, Matsuyama

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

501-1194

Gifu University Hospital, Gifu

060-8648

Hokkaido University Hospital, Sapporo

673-8558

Hyogo Cancer Center, Akashi-shi

650-0047

Kobe City Medical Center General Hospital, Kobe

920-8530

Ishikawa Prefectural Central Hospital, Kanazawa

761-0793

Kagawa University Hospital, Kita-gun

232-0024

Yokohama City University Medical Center, Yokohama

241-8515

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama

606-8507

Kyoto University Hospital, Kyoto

951-8566

Niigata Cancer Center Hospital, Niigata

573-1191

Kansai Medical University Hospital, Hirakata-shi

541-8567

Osaka International Cancer Institute, Osaka

589-8511

Kindai University Hospital, Osakasayama-shi

565-0871

Osaka University Hospital, Suita-shi

362-0806

Saitama Cancer Center, Kitaadachi-gun

411-8777

Shizuoka Cancer Center, Sunto-gun

135-8550

The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku

160-8582

Keio University Hospital, Shinjuku-ku

08660

Nacionalinis vezio institutas, Vilnius

08661

Vilnius University Hospital Santaros Clinic Public Institution, Vilnius

06720

Trials In Medicine SC, México

0424

Oslo University Hospital, Oslo

04001

Centro Medico Monte Carmelo, Arequipa

85-796

Centrum Onkologii im prof Franciszka Lukaszczyka, Bydgoszcz

81-519

Szpitale Pomorskie Spzoo, Gdynia

05-410

Biokinetica SA, Józefów

75-581

Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie, Koszalin

10-228

Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji, Olsztyn

45-060

SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu, Opole

61-866

Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie, Poznan

37-700

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu, Przemyśl

26-600

Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal, Radom

3004-561

Unidade Local de Saude de Coimbra, EPE, Coimbra

4835-044

Unidade Local de Saude do Alto Ave, EPE, Guimarães

1649-035

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria, Lisbon

4099-001

Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio, Porto

4200-072

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE, Porto

4200-319

Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao, Porto

4520-211

Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao, Santa Maria da Feira

022328

Institutul Clinic Fundeni, Bucharest

022338

Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti, Bucharest

0002

Steve Biko Academic Hospital, Pretoria

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

09006

Hospital Universitario de Burgos, Burgos

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08208

Corporacio Sanitaria Parc Tauli, Sabadell

413 45

Sahlgrenska Universitetssjukhuset, Gothenburg

141 86

Karolinska Universitetssjukhuset Huddinge, Stockholm

901 85

Norrlands Universitetssjukhus, Umeå

01250

Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi, Adana

06100

Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara

06230

Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara

06520

Memorial Ankara Hastanesi, Ankara

06800

Ankara Bilkent Sehir Hastanesi, Ankara

07100

Antalya Egitim ve Arastirma Hastanesi, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Zai Lab (China only)

UNKNOWN

lead

Amgen

INDUSTRY