AzTrials
AzTrials

Gastric CancerPhase 3NCT06731478

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

A Phase 3 study testing Trastuzumab Deruxtecan, pembrolizumab and Trastuzumab in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Daiichi Sankyo at 250 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab Deruxtecan, pembrolizumab and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
726 participants
Where
250 sitesin 26 countries
Study dates
27 Feb 2025to 1 Feb 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.
  • Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
  • Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and/or adjuvant setting is permissible, provided there is >6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.
  • Note: Prior use of IO (ie, anti-PD-1/PD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is >6 months between the end of IO therapy and the diagnosis of recurrent disease.
  • Centrally determined HER2-positive (IHC 3+ or IHC 2+/ISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.
  • Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.
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  • Centrally determined tumor PD-L1 CPS using the PD-L1 assay:
  • For the Main Cohort: PD-L1 CPS ≥1
  • For the Exploratory Cohort: PD-L1 CPS <1
  • All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.
  • At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
  • LVEF ≥50% within 28 days before randomization.

Who cannot join

  • Prior exposure to other HER2-targeting therapies (including ADCs).
  • Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.
  • Known total or partial DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions/countries where DPD testing is SoC and with unknown DPD status. For regions/countries where DPD testing is not SoC, local practice should be followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.
  • Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.
  • Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.
  • Has a corrected QT interval (QTcF) prolongation to >470 ms (females) or >450 ms (males) based on the average of the screening triplicate 12-lead ECG.
  • Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
  • Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).

Trial locations and contacts

250 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Contact for Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

250 sites in 26 countries

China27 sites, 27 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Recruiting

  • The First People's Hospital of Changzhou

    Changzhou

    Not yet 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

    Recruiting

  • Lanzhou University Second Hospital

    Lanzhou

    Not yet recruiting

  • Linyi Cancer Hospital

    Linyi

    Recruiting

  • Meizhou People's Hospital

    Meizhou

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan

    Recruiting

  • Shanxi Provincial People's Hospital

    Taiyuan

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Recruiting

  • The Affiliated Cancer Hospital of Xinjiang Medical university

    Ürümqi

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079

    Recruiting

  • Wuxi 4th People's Hospital

    Wuxi

    Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an

    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

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Recruiting

Other trials in China

United States18 sites, 15 recruiting

  • University of Michigan Comprehensive Cancer Center Michigan Medicine

    Ann Arbor, Michigan, 48109

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

    Recruiting

  • Prisma Health Cancer Institute, ITOR, CRU

    Greenville, South Carolina, 29605

    Recruiting

  • Penn State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

    Not yet recruiting

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

    Withdrawn

  • Tennessee Oncology Nashville Midtown

    Nashville, Tennessee, 37203

    Withdrawn

  • Yale Cancer Center

    New Haven, Connecticut, 06511

    Not yet recruiting

  • Memorial Sloan Kettering Cancer Center - MAIN

    New York, New York, 10065

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502-1871

    Not yet recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Recruiting

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

    Not yet recruiting

  • Maryland Oncology Hematology, P.A.

    Silver Spring, Maryland, 20904

    Not yet recruiting

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

    Not yet recruiting

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

    Withdrawn

Other trials in United States

Japan17 sites, 17 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

  • JCHO Kyushu Hospital

    Kitakyushu, 806-0034

    Recruiting

  • Kochi Health Sciences Center

    Kochi

    Recruiting

  • Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

    Recruiting

  • NHO Shikoku Cancer Center

    Matsuyama, 791-0280

    Recruiting

  • Aichi Cancer Center Hospital

    Nagoya

    Recruiting

  • Miyagi Cancer Center

    Natori-shi

    Recruiting

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Recruiting

  • Kindai University Hospital

    Osakasayama-shi, 589-8511

    Recruiting

  • Hokkaido University Hospital

    Sapporo, 060-8648

    Recruiting

  • Osaka University Hospital

    Suita-shi, 565-0871

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241-8515

    Recruiting

Other trials in Japan

Spain17 sites, 17 recruiting

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona

    Recruiting

  • Hospital del Mar

    Barcelona

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba

    Recruiting

  • Hospital General Universitario de Elche

    Elche

    Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat

    Not yet recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid

    Recruiting

  • MD Anderson Cancer Centre

    Madrid

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga

    Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia

    Recruiting

Other trials in Spain

France16 sites, 16 recruiting

  • Institut Sainte Catherine

    Avignon

    Recruiting

  • CHU de Brest - Hopital de la Cavale Blanche

    Brest

    Recruiting

  • Centre Georges François Leclerc

    Dijon

    Recruiting

  • CHU Grenoble - Hopital Michallon

    Grenoble

    Recruiting

  • Centre Oscar Lambret

    Lille

    Recruiting

  • Hopital Prive Jean Mermoz

    Lyon

    Recruiting

  • CHU Montpellier, Saint Eloi

    Montpellier

    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

    Recruiting

Other trials in France

Italy16 sites, 16 recruiting

  • Presidio Ospedaliero Garibaldi Nesima

    Catania

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florenze

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova

    Recruiting

  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

    Milan

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

    Recruiting

  • Ospedale San Raffaele

    Milan

    Recruiting

  • A.O.U. Policlinico di Modena

    Modena

    Recruiting

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

    Naples

    Recruiting

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

    Recruiting

  • Azienda Unità Sanitaria Locale- Ravenna

    Ravenna

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano

    Recruiting

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

    Recruiting

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

    Torino

    Recruiting

  • Azienda Ospedaliera Card. G. Panico

    Tricase

    Recruiting

Other trials in Italy

South Korea14 sites, 14 recruiting

  • Chungbuk National University Hospital

    Cheongju-si

    Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu

    Recruiting

  • National Cancer Center

    Goyang-si

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, 58128

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Recruiting

  • Jeonbuk national university hospital

    Jeonju, 54907

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620

    Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si

    Recruiting

  • Korea University Anam Hospital

    Seoul, 2841

    Recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

    Recruiting

  • Asan Medical Center

    Seoul, 5505

    Recruiting

  • Samsung Medical Center

    Seoul, 6351

    Recruiting

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

    Seoul

    Recruiting

Other trials in South Korea

Brazil12 sites, 12 recruiting

  • Centro de Oncologia - Unidade Brasilia - Hospital Sirio Libanes

    Brasília

    Recruiting

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

    Brazil

    Recruiting

  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

    Florianópolis

    Recruiting

  • Fundação Doutor Amaral Carvalho

    Jaú

    Recruiting

  • Liga Norte-Rio-Grandense Contra o Câncer

    Natal

    Recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre

    Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre

    Recruiting

  • IMIP - Instituto de Medicina Integral Professor Fernando Figueira

    Recife

    Recruiting

  • Hospital das Clínicas FMRP-USP

    Ribeirão Preto

    Recruiting

  • INCA - Instituto Nacional de Câncer

    Rio de Janeiro

    Recruiting

  • Obras Sociais Irmã Dulce - Hospital Santo Antônio

    Salvador

    Recruiting

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

    Sao Jose Rio Preto

    Recruiting

Other trials in Brazil

Turkey (Türkiye)10 sites, 9 recruiting

  • Medical Park Seyhan Hospital

    Adana

    Recruiting

  • Ankara City Hospital

    Ankara

    Not yet recruiting

  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Ankara

    Recruiting

  • Hacettepe University Medical Faculty

    Ankara

    Recruiting

  • Dicle University, Medical faculty

    Diyarbakır

    Recruiting

  • Ataturk University Medical Faculty

    Erzurum

    Recruiting

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul

    Recruiting

  • Medipol University Medical Faculty

    Istanbul

    Recruiting

  • İ.E.Ü. Medicalpoint İzmir Hastanesi

    Izmir

    Withdrawn

  • Medical Park Samsun Hastanesi

    Samsun

    Not yet recruiting

Other trials in Turkey (Türkiye)

United Kingdom10 sites, 10 recruiting

  • Queen Elizabeth Hospital

    Birmingham

    Recruiting

  • Velindre Cancer Centre

    Cardiff

    Recruiting

  • Ninewells Hospital

    Dundee

    Recruiting

  • Castle Hill Hospital

    Hull

    Recruiting

  • St James's University Hospital

    Leeds

    Recruiting

  • Sarah Cannon Research Institute UK

    London

    Recruiting

  • University College London Hospitals

    London

    Recruiting

  • Altnagelvin Area Hospital

    Londonderry

    Recruiting

  • The Christie Hospital

    Manchester

    Recruiting

  • Royal Marsden Hospital

    Sutton

    Recruiting

Other trials in United Kingdom

Germany9 sites, 9 recruiting

  • Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum

    Berlin

    Recruiting

  • Vivantes Klinikum im Friedrichshain

    Berlin

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden

    Recruiting

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg

    Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg

    Recruiting

  • Universitaetsklinikum Leipzig AoeR

    Leipzig

    Recruiting

  • Klinikum rechts der Isar der TU Muenchen

    München

    Recruiting

Other trials in Germany

Canada8 sites, 6 recruiting

  • Cité de la Santé de Laval

    Laval, H7M 3L9

    Withdrawn

  • Trillium Health Partners Credit Valley Hospital

    Mississauga, L5M 2N1

    Not yet recruiting

  • St. Mary's Hospital

    Montreal, H3T 1M5

    Not yet recruiting

  • CHUS - Hôtel-Dieu

    Sherbrooke

    Not yet recruiting

  • Mount Sinai Hospital

    Toronto, M5G 1X5

    Not yet recruiting

  • Mount Sinai Hospital

    Toronto, M5G 1X5

    Withdrawn

  • Sunnybrook Health Sciences Centre

    Toronto

    Recruiting

  • University Health Network - Princess Margaret Cancer Centre

    Toronto

    Not yet recruiting

Other trials in Canada

Australia7 sites, 7 recruiting

  • Flinders Medical Centre

    Bedford Park

    Recruiting

  • Monash Medical Centre Clayton

    Clayton

    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

    Recruiting

  • Wollongong Hospital

    Wollongong

    Recruiting

Other trials in Australia

Romania7 sites, 7 recruiting

  • Institutul Clinic Fundeni

    Bucharest

    Recruiting

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

    Cluj-Napoca

    Recruiting

  • S.C Medisprof S.R.L

    Cluj-Napoca

    Recruiting

  • Centrul de Oncologie Sfantul Nectarie Craiova

    Craiova

    Recruiting

  • Institutul Regional de Oncologie Iasi

    Iași

    Recruiting

  • S.C Ovidius Clinical Hospital S.R.L

    Ovidiu

    Recruiting

  • S.C. Sigmedical Services SRL

    Suceava

    Recruiting

Other trials in Romania

Belgium6 sites, 6 recruiting

  • Institut Jules Bordet

    Anderlecht

    Recruiting

  • AZ Sint-Lucas

    Bruges

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels

    Recruiting

  • UZ Leuven

    Leuven

    Recruiting

  • Centre Hospitalier Universitaire de Liege

    Liège

    Recruiting

  • CHU UCL Namur

    Namur

    Recruiting

Other trials in Belgium

Chile6 sites, 6 recruiting

  • Biocenter

    Concepción

    Recruiting

  • URUMED Spa

    Rancagua

    Recruiting

  • Centro de Investigacion del Maule

    Region Del Maule

    Recruiting

  • Centro de Estudios Clinicos SAGA

    Santiago

    Recruiting

  • FALP - Fundación Arturo López Pérez

    Santiago

    Recruiting

  • Hospital Clinico Universidad de Chile

    Santiago

    Not yet recruiting

Other trials in Chile

Netherlands6 sites, 6 recruiting

  • Antoni van Leeuwenhoek

    Amsterdam

    Recruiting

  • Medisch Centrum Leeuwarden

    Leeuwarden

    Recruiting

  • Radboudumc

    Nijmegen

    Recruiting

  • Erasmus Medisch Centrum

    Rotterdam

    Recruiting

  • ETZ Elisabeth

    Tilburg

    Not yet recruiting

  • UMC Utrecht

    Utrecht

    Recruiting

Other trials in Netherlands

Portugal6 sites, 6 recruiting

  • Hospital de Braga

    Braga

    Recruiting

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

    Guimarães

    Recruiting

  • Fundação Champalimaud

    Lisbon

    Not yet recruiting

  • Hospital da Luz

    Lisbon

    Recruiting

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

    Lisbon

    Recruiting

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto

    Recruiting

Other trials in Portugal

Argentina5 sites, 5 recruiting

  • CEMIC Ciudad Autonoma

    Buenos Aires

    Not yet recruiting

  • Instituto Medico Especializado Alexander Fleming

    Buenos Aires

    Recruiting

  • Clinica Universitaria Privada Reina Fabiola

    Córdoba

    Recruiting

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata

    Recruiting

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario

    Recruiting

Other trials in Argentina

Austria5 sites, 5 recruiting

  • LKH - Universitaetsklinikum Graz

    Graz

    Recruiting

  • Medizinische Universität Innsbruck

    Innsbruck

    Recruiting

  • Medizinische Universität Wien

    Vienna

    Recruiting

  • St. Josef Krankenhaus Wien

    Vienna

    Recruiting

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt

    Recruiting

Other trials in Austria

Poland5 sites, 5 recruiting

  • Beskidzkie Centrum Onkologii im.Jana Pawla II

    Bielsko-Biala

    Recruiting

  • Szpital Wojewodzki im. Mikolaja Kopernika

    Koszalin

    Recruiting

  • Wielkopolskie Centrum Onkologii

    Poznan

    Recruiting

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

    Warsaw

    Recruiting

  • Warszawski Uniwersytet Medyczny

    Warsaw

    Not yet recruiting

Other trials in Poland

Taiwan5 sites, 5 recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Recruiting

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan City, 333

    Recruiting

Other trials in Taiwan

Thailand5 sites, 5 recruiting

  • Siriraj Hospital

    Bangkoknoi

    Recruiting

  • Vajira Hospital

    Dusit

    Recruiting

  • Songklanagarind Hospital

    Hat Yai

    Recruiting

  • Chulabhorn Hospital

    Laksi

    Recruiting

  • King Chulalongkorn Memorial Hospital

    Pathum Wan

    Recruiting

Other trials in Thailand

Vietnam5 sites, 5 recruiting

  • Hanoi Oncology hospital

    Hanoi

    Recruiting

  • National Cancer Hospital

    Hanoi

    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

    Not yet recruiting

Other trials in Vietnam

Czechia4 sites, 4 recruiting

  • Masarykuv onkologicky ustav

    Brno

    Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové

    Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc

    Recruiting

  • Fakultni nemocnice v Motole

    Prague

    Recruiting

Other trials in Czechia

Norway4 sites, 4 recruiting

  • Haukeland University Hospital

    Bergen

    Recruiting

  • Akershus universitetssykehus HF

    Lørenskog

    Recruiting

  • Oslo Universitetssykehus HF, Ullevål

    Oslo

    Recruiting

  • St. Olavs Hospital Hf, Universitetssykehuset i Trondheim

    Trondheim

    Recruiting

Other trials in Norway

About this study

Official title: A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)

This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS <1 gastric or GEJ cancer.

Being tested
Trastuzumab Deruxtecan, pembrolizumab, Trastuzumab, Chemotherapy
Keywords
Enhertu, Trastuzumab Deruxtecan, Chemotherapy, DS-8201a, HER2 positive
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab DeruxtecanDrug

    Also called T-DXd, ENHERTU®, DS-8201a

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

  • pembrolizumabDrug

    Also called KEYTRUDA®

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

  • TrastuzumabDrug

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

  • ChemotherapyDrug

    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 be administered.

Study groups in NCT06731478
Study groupRoleWhat they receive
Main Cohort: Arm M1ExperimentalParticipants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) plus pembrolizumab
Receives: Drug: Trastuzumab Deruxtecan; Drug: pembrolizumab; Drug: Chemotherapy
Main Cohort: Arm M2ExperimentalParticipants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) plus pembrolizumab
Receives: Drug: pembrolizumab; Drug: Trastuzumab; Drug: Chemotherapy
Exploratory Cohort: Arm E1ExperimentalParticipants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine)
Receives: Drug: Trastuzumab Deruxtecan; Drug: Chemotherapy
Exploratory Cohort: Arm E2ExperimentalParticipants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine)
Receives: Drug: Trastuzumab; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression as assessed by blinded independent central review (BICR) based on RECIST v1.1 or death due to any cause.

    Measured: From date of randomization to the date of radiographic disease progression or death due to any cause, up to 59 months

Secondary outcomes (1)

  1. Overall Survival (OS)

    OS is defined as the time interval from the date of randomization to the date of death due to any cause.

    Measured: From date of randomization to the date of death due to any cause, up to 59 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start27 Feb 2025
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Feb 2030 (estimated)

Resources

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
None (open label)
Enrolment
726 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731478
Sponsor's protocol ID
DS8201-724
Other IDs
KEYNOTE-G03, MK-3475-G03
Status last verified
Aug 2026
First submitted
9 Dec 2024
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab Deruxtecan, pembrolizumab and Trastuzumab in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Daiichi Sankyo at 250 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 250 sites in China, United States, Japan, Spain, France and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact for Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From date of randomization to the date of radiographic disease progression or death due to any cause, up to 59 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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