Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

726

Participants

Timeline

Start Date

February 27, 2025

Primary Completion Date

June 1, 2028

Study Completion Date

February 1, 2030

Conditions
Gastric CancerGastroesophageal Junction Cancer
Interventions
DRUG

Trastuzumab Deruxtecan

T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)

DRUG

pembrolizumab

Pembrolizumab will be administered at a dose of 200 mg IV Q3W

DRUG

Trastuzumab

Trastuzumab will be administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg IV Q3W

DRUG

Chemotherapy

"For Arms M1 and E1: 5-FU or capecitabine will be administered.~For Arms M2 and E2: Cisplatin plus 5-FU or oxaliplatin plus capecitabine will administered."

Trial Locations (245)

333

RECRUITING

Chang Gung Memorial Hospital,Linkou, Taoyuan

2841

RECRUITING

Korea University Anam Hospital, Seoul

3080

RECRUITING

Seoul National University Hospital, Seoul

3722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

5505

RECRUITING

Asan Medical Center, Seoul

6351

RECRUITING

Samsung Medical Center, Seoul

10065

NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center - MAIN, New York

10467

NOT_YET_RECRUITING

Montefiore Medical Center, The Bronx

13620

RECRUITING

Seoul National University Bundang Hospital, Seongnam

17033

NOT_YET_RECRUITING

Penn State University Milton S. Hershey Medical Center, Hershey

20904

NOT_YET_RECRUITING

Maryland Oncology Hematology, P.A., Silver Spring

21565

RECRUITING

Gachon University Gil Medical Center, Incheon

24014

NOT_YET_RECRUITING

Blue Ridge Cancer Care, Roanoke

29605

NOT_YET_RECRUITING

Prisma Health Cancer Institute, ITOR, CRU, Greenville

37203

NOT_YET_RECRUITING

Tennessee Oncology Nashville Midtown, Nashville

48109

NOT_YET_RECRUITING

University of Michigan Comprehensive Cancer Center Michigan Medicine, Ann Arbor

54907

RECRUITING

Jeonbuk national university hospital, Jeonju

55407

WITHDRAWN

Minnesota Oncology Hematology, P.A., Minneapolis

58128

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun-gun

60077

RECRUITING

Orchard Healthcare Research Inc., Skokie

66160

NOT_YET_RECRUITING

University of Kansas Medical Center Research Institute, Inc., Kansas City

75235

NOT_YET_RECRUITING

UT Southwestern Medical Center, Dallas

75702

NOT_YET_RECRUITING

Texas Oncology, P.A. - Tyler, Tyler

97213

NOT_YET_RECRUITING

Providence Portland Medical Center, Portland

98801

WITHDRAWN

Wenatchee Valley Hospital & Clinics, Wenatchee

100142

RECRUITING

Beijing Cancer Hospital, Beijing

100191

RECRUITING

Peking University Third Hospital, Beijing

112201

RECRUITING

Taipei Veterans General Hospital, Taipei

430079

RECRUITING

Hubei Cancer Hospital, Wuhan

06520-8028

NOT_YET_RECRUITING

Yale Cancer Center, New Haven

02111

NOT_YET_RECRUITING

Tufts Medical Center, Boston

23502-1871

NOT_YET_RECRUITING

Virginia Oncology Associates, Norfolk

Unknown

NOT_YET_RECRUITING

CEMIC Ciudad Autonoma, Buenos Aires

NOT_YET_RECRUITING

Instituto Medico Especializado Alexander Fleming, Buenos Aires

NOT_YET_RECRUITING

Clinica Universitaria Privada Reina Fabiola, Córdoba

NOT_YET_RECRUITING

Centro de Investigaciones Medicas Mar del Plata, Mar del Plata

NOT_YET_RECRUITING

Instituto Medico de la Fundacion Estudios Clinicos, Rosario

NOT_YET_RECRUITING

Flinders Medical Centre, Bedford Park

RECRUITING

Monash Medical Centre Clayton, Clayton

NOT_YET_RECRUITING

Townsville University Hospital, Douglas

RECRUITING

Peter MacCallum Cancer Centre, North Melbourne

RECRUITING

GenesisCare North Shore (Oncology), St Leonards

RECRUITING

St John of God Subiaco Hospital, Subiaco

NOT_YET_RECRUITING

Wollongong Hospital, Wollongong

NOT_YET_RECRUITING

LKH - Universitaetsklinikum Graz, Graz

NOT_YET_RECRUITING

Medizinische Universität Innsbruck, Innsbruck

NOT_YET_RECRUITING

Medizinische Universität Wien, Vienna

NOT_YET_RECRUITING

St. Josef Krankenhaus Wien, Vienna

NOT_YET_RECRUITING

Landesklinikum Wiener Neustadt, Wiener Neustadt

RECRUITING

Institut Jules Bordet, Anderlecht

RECRUITING

AZ Sint-Lucas, Bruges

RECRUITING

Cliniques Universitaires Saint-Luc, Brussels

NOT_YET_RECRUITING

UZ Leuven, Leuven

NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Liege, Liège

RECRUITING

CHU UCL Namur, Namur

NOT_YET_RECRUITING

Centro de Oncologia - Unidade Brasilia - Hospital Sirio Libanes, Brasília

NOT_YET_RECRUITING

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira Sao Paulo, Brazil

NOT_YET_RECRUITING

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina, Florianópolis

NOT_YET_RECRUITING

Fundação Doutor Amaral Carvalho, Jaú

NOT_YET_RECRUITING

Liga Norte-Rio-Grandense Contra o Câncer, Natal

NOT_YET_RECRUITING

Hospital de Clínicas de Porto Alegre, Porto Alegre

NOT_YET_RECRUITING

Hospital São Lucas da PUCRS, Porto Alegre

NOT_YET_RECRUITING

IMIP - Instituto de Medicina Integral Professor Fernando Figueira, Recife

NOT_YET_RECRUITING

Hospital das Clínicas FMRP-USP, Ribeirão Preto

NOT_YET_RECRUITING

INCA - Instituto Nacional de Câncer, Rio de Janeiro

NOT_YET_RECRUITING

Obras Sociais Irmã Dulce - Hospital Santo Antônio, Salvador

NOT_YET_RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Sao Jose Rio Preto

NOT_YET_RECRUITING

CHUS - Hôtel-Dieu, Sherbrooke

NOT_YET_RECRUITING

Sunnybrook Health Sciences Centre, Toronto

NOT_YET_RECRUITING

University Health Network - Princess Margaret Cancer Centre, Toronto

NOT_YET_RECRUITING

Biocenter, Concepción

NOT_YET_RECRUITING

URUMED Spa, Rancagua

NOT_YET_RECRUITING

Centro de Investigacion del Maule, Region Del Maule

NOT_YET_RECRUITING

Centro de Estudios Clinicos SAGA, Santiago

RECRUITING

FALP - Fundación Arturo López Pérez, Santiago

NOT_YET_RECRUITING

Hospital Clinico Universidad de Chile, Santiago

RECRUITING

Fujian Cancer Hospital, Fuzhou

RECRUITING

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

RECRUITING

The First Affiliated Hospital of Zhejiang University school of medicine, Hangzhou

RECRUITING

Harbin Medical University Cancer Hospital, Harbin

RECRUITING

Anhui Provincial Cancer Hospital, Hefei

RECRUITING

Shandong Cancer Hospital, Jinan

RECRUITING

Gansu Provincial Cancer Hospital, Lanzhou

NOT_YET_RECRUITING

Lanzhou University Second Hospital, Lanzhou

RECRUITING

Linyi Cancer Hospital, Linyi

RECRUITING

Meizhou People's Hospital, Meizhou

NOT_YET_RECRUITING

Liaoning Cancer Hospital & Institute, Shenyang

RECRUITING

The Second Affiliated Hospital of Soochow University, Suzhou

NOT_YET_RECRUITING

Shanxi Provincial Cancer Hospital, Taiyuan

NOT_YET_RECRUITING

Shanxi Provincial People's Hospital, Taiyuan

RECRUITING

Tianjin Medical University Cancer Institute & Hospital, Tianjin

NOT_YET_RECRUITING

The Affiliated Cancer Hospital of Xinjiang Medical university, Ürümqi

RECRUITING

Wuxi 4th People's Hospital, Wuxi

RECRUITING

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

NOT_YET_RECRUITING

The First Affiliated Hospital of Xiamen University, Xiamen

NOT_YET_RECRUITING

Fudan University Shanghai Cancer Center, Xuhui District

RECRUITING

Xuzhou Central Hospital, Xuzhou

RECRUITING

General Hospital of Ningxia Medical University, Yinchuan

NOT_YET_RECRUITING

Masarykuv onkologicky ustav, Brno

NOT_YET_RECRUITING

Fakultni nemocnice Hradec Kralove, Hradec Králové

NOT_YET_RECRUITING

Fakultni nemocnice Olomouc, Olomouc

NOT_YET_RECRUITING

Fakultni nemocnice v Motole, Prague

RECRUITING

Institut Sainte Catherine, Avignon

RECRUITING

CHU de Brest - Hopital de la Cavale Blanche, Brest

NOT_YET_RECRUITING

Centre Georges François Leclerc, Dijon

RECRUITING

CHU Grenoble - Hopital Michallon, Grenoble

RECRUITING

Centre Oscar Lambret, Lille

NOT_YET_RECRUITING

Hopital Prive Jean Mermoz, Lyon

RECRUITING

CHU Montpellier, Saint Eloi, Montpellier

NOT_YET_RECRUITING

Chru De Nantes Hotel-Dieu, Nantes

RECRUITING

Hôpital Européen Georges Pompidou, Paris

RECRUITING

Hôpital Saint-Antoine, Paris

RECRUITING

Institut Mutualiste Montsouris, Paris

RECRUITING

CHU Bordeaux - Hôpital Haut-Lévêque, Pessac

RECRUITING

CHU Poitiers - Hôpital la Milétrie, Poitiers

RECRUITING

Institut de Cancérologie de Strasbourg Europe - ICANS, Strasbourg

RECRUITING

Hôpital Foch, Suresnes

RECRUITING

Hopital Rangueil, Toulouse

NOT_YET_RECRUITING

Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum, Berlin

NOT_YET_RECRUITING

Vivantes Klinikum im Friedrichshain, Berlin

NOT_YET_RECRUITING

Klinikum Chemnitz gGmbH, Chemnitz

NOT_YET_RECRUITING

Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden

NOT_YET_RECRUITING

Universitaetsklinikum Frankfurt Goethe-Universitaet, Frankfurt am Main

NOT_YET_RECRUITING

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

NOT_YET_RECRUITING

Universitaetsklinikum Heidelberg, Heidelberg

NOT_YET_RECRUITING

Universitaetsklinikum Leipzig AoeR, Leipzig

NOT_YET_RECRUITING

Klinikum rechts der Isar der TU Muenchen, München

NOT_YET_RECRUITING

Presidio Ospedaliero Garibaldi Nesima, Catania

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Careggi, Florenze

NOT_YET_RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda), Milan

NOT_YET_RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

NOT_YET_RECRUITING

Ospedale San Raffaele, Milan

NOT_YET_RECRUITING

A.O.U. Policlinico di Modena, Modena

NOT_YET_RECRUITING

"Azienda Ospedaliera Universitaria- Università degli Studi della Campania Luigi Vanvitelli", Napoli

NOT_YET_RECRUITING

IOV - Istituto Oncologico Veneto IRCCS, Padua

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Pisana, Pisa

NOT_YET_RECRUITING

Azienda Unità Sanitaria Locale- Ravenna, Ravenna

NOT_YET_RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

NOT_YET_RECRUITING

Istituto Clinico Humanitas, Rozzano

NOT_YET_RECRUITING

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino

NOT_YET_RECRUITING

Azienda Ospedaliera Card. G. Panico, Tricase

RECRUITING

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Bunkyō City

RECRUITING

National Cancer Center Hospital, Chūōku

RECRUITING

Gifu University Hospital, Gifu

RECRUITING

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

RECRUITING

National Cancer Center Hospital East, Kashiwa-shi

RECRUITING

Kochi Health Sciences Center, Kochi

RECRUITING

Aichi Cancer Center Hospital, Nagoya

RECRUITING

Miyagi Cancer Center, Natori-shi

NOT_YET_RECRUITING

Antoni van Leeuwenhoek, Amsterdam

NOT_YET_RECRUITING

Medisch Centrum Leeuwarden, Leeuwarden

RECRUITING

Radboudumc, Nijmegen

NOT_YET_RECRUITING

Erasmus Medisch Centrum, Rotterdam

NOT_YET_RECRUITING

ETZ Elisabeth, Tilburg

NOT_YET_RECRUITING

UMC Utrecht, Utrecht

NOT_YET_RECRUITING

Haukeland University Hospital, Bergen

NOT_YET_RECRUITING

Akershus universitetssykehus HF, Lørenskog

NOT_YET_RECRUITING

Oslo Universitetssykehus HF, Ullevål, Oslo

NOT_YET_RECRUITING

St. Olavs Hospital Hf, Universitetssykehuset i Trondheim, Trondheim

NOT_YET_RECRUITING

Beskidzkie Centrum Onkologii im.Jana Pawla II, Bielsko-Biala

NOT_YET_RECRUITING

Szpital Wojewodzki im. Mikolaja Kopernika, Koszalin

NOT_YET_RECRUITING

Wielkopolskie Centrum Onkologii, Poznan

NOT_YET_RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy W Warszawie, Warsaw

NOT_YET_RECRUITING

Warszawski Uniwersytet Medyczny, Warsaw

NOT_YET_RECRUITING

Hospital de Braga, Braga

NOT_YET_RECRUITING

Hospital da Senhora da Oliveira Guimarães, E.P.E., Guimarães

NOT_YET_RECRUITING

Fundação Champalimaud, Lisbon

NOT_YET_RECRUITING

Hospital da Luz, Lisbon

NOT_YET_RECRUITING

Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria, Lisbon

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Institutul Clinic Fundeni, Bucharest

NOT_YET_RECRUITING

"Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca", Cluj-Napoca

NOT_YET_RECRUITING

S.C Medisprof S.R.L, Cluj-Napoca

NOT_YET_RECRUITING

Centrul de Oncologie Sfantul Nectarie Craiova, Craiova

NOT_YET_RECRUITING

Institutul Regional de Oncologie Iasi, Iași

NOT_YET_RECRUITING

S.C Ovidius Clinical Hospital S.R.L, Ovidiu

NOT_YET_RECRUITING

S.C. Sigmedical Services SRL, Suceava

RECRUITING

Chungbuk National University Hospital, Cheongju-si

RECRUITING

Kyungpook National University Chilgok Hospital, Daegu

RECRUITING

National Cancer Center, Goyang-si

RECRUITING

CHA Bundang Medical Center, CHA University, Seongnam-si

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

NOT_YET_RECRUITING

ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona

NOT_YET_RECRUITING

Hospital Clinic de Barcelona, Barcelona

NOT_YET_RECRUITING

Hospital del Mar, Barcelona

NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

NOT_YET_RECRUITING

Hospital Universitario Reina Sofia, Córdoba

NOT_YET_RECRUITING

Hospital General Universitario de Elche, Elche

NOT_YET_RECRUITING

ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat

NOT_YET_RECRUITING

Hospital General Universitario Gregorio Marañon, Madrid

NOT_YET_RECRUITING

Hospital Universitario La Paz, Madrid

NOT_YET_RECRUITING

Hospital Universitario Ramon y Cajal, Madrid

NOT_YET_RECRUITING

MD Anderson Cancer Centre, Madrid

NOT_YET_RECRUITING

Hospital Regional Universitario de Malaga, Málaga

NOT_YET_RECRUITING

Hospital General Universitario Morales Meseguer, Murcia

NOT_YET_RECRUITING

Hospital Universitario Central de Asturias, Oviedo

NOT_YET_RECRUITING

Hospital Universitario de Navarra, Pamplona

NOT_YET_RECRUITING

Hospital Universitario Virgen del Rocio, Seville

NOT_YET_RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

RECRUITING

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

RECRUITING

National Cheng Kung University Hospital, Tainan City

RECRUITING

National Taiwan University Hospital, Taipei

RECRUITING

Siriraj Hospital, Bangkoknoi

NOT_YET_RECRUITING

Vajira Hospital, Dusit

RECRUITING

Songklanagarind Hospital, Hat Yai

NOT_YET_RECRUITING

Chulabhorn Hospital, Laksi

NOT_YET_RECRUITING

King Chulalongkorn Memorial Hospital, Pathum Wan

NOT_YET_RECRUITING

Medical Park Seyhan Hospital, Adana

NOT_YET_RECRUITING

Ankara City Hospital, Ankara

NOT_YET_RECRUITING

Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital, Ankara

NOT_YET_RECRUITING

Hacettepe University Medical Faculty, Ankara

NOT_YET_RECRUITING

Dicle University, Medical faculty, Diyarbakır

NOT_YET_RECRUITING

Ataturk University Medical Faculty, Erzurum

NOT_YET_RECRUITING

Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul

NOT_YET_RECRUITING

Medipol University Medical Faculty, Istanbul

NOT_YET_RECRUITING

İ.E.Ü. Medicalpoint İzmir Hastanesi, Izmir

NOT_YET_RECRUITING

Medical Park Samsun Hastanesi, Samsun

NOT_YET_RECRUITING

Queen Elizabeth Hospital, Birmingham

NOT_YET_RECRUITING

Velindre Cancer Centre, Cardiff

NOT_YET_RECRUITING

Ninewells Hospital, Dundee

NOT_YET_RECRUITING

Castle Hill Hospital, Hull

NOT_YET_RECRUITING

St James's University Hospital, Leeds

NOT_YET_RECRUITING

Sarah Cannon Research Institute UK, London

NOT_YET_RECRUITING

University College London Hospitals, London

NOT_YET_RECRUITING

Altnagelvin Area Hospital, Londonderry

NOT_YET_RECRUITING

The Christie Hospital, Manchester

NOT_YET_RECRUITING

Royal Marsden Hospital, Sutton

NOT_YET_RECRUITING

Hanoi Oncology hospital, Hanoi

NOT_YET_RECRUITING

National Cancer Hospital, Hanoi

NOT_YET_RECRUITING

Cho Ray Hospital, Ho Chi Minh City

NOT_YET_RECRUITING

HCMC Oncology Hospital, Ho Chi Minh City

NOT_YET_RECRUITING

HCMC University Medical Center, HoChiMinh

H7M 3L9

NOT_YET_RECRUITING

Cité de la Santé de Laval, Laval

M5G 1X5

WITHDRAWN

Mount Sinai Hospital, Toronto

806-0034

RECRUITING

JCHO Kyushu Hospital, Kitakyushu

135-8550

RECRUITING

Cancer Institute Hospital of JFCR, Kōtoku

791-0280

RECRUITING

NHO Shikoku Cancer Center, Matsuyama

951-8566

RECRUITING

Niigata Cancer Center Hospital, Niigata

541-8567

RECRUITING

Osaka International Cancer Institute, Osaka

589-8511

RECRUITING

Kindai University Hospital, Osakasayama-shi

060-8648

RECRUITING

Hokkaido University Hospital, Sapporo

565-0871

RECRUITING

Osaka University Hospital, Suita-shi

241-8515

RECRUITING

Kanagawa Cancer Center, Yokohama

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY

NCT06731478 - Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer | Biotech Hunter | Biotech Hunter