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ACTIVE NOT RECRUITING
NCT04704934
PHASE3

Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy.

Official title: A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

490

Start Date

2021-05-21

Completion Date

2026-08-31

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DRUG

Trastuzumab deruxtecan

6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle

DRUG

Ramucirumab

8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle

DRUG

Paclitaxel

80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle

Locations (156)

Instituto Medico Especializado Alexander Fleming

Colegiales, Buenos Aires F.D., Argentina

IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo

Nueva Cordoba, Córdoba Province, Argentina

Exelsus

San Miguel de Tucumán, Tucumán Province, Argentina

Fundacion Cenit

Buenos Aires, Argentina

UCL St. Luc

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

Pôle Hospitalier Jolimont

Haine-Saint-Paul, Belgium

UZ Leuven

Leuven, Belgium

PERSONAL - Oncologia de Precisao e Personalizada

Belo Horizonte, Brazil

Hospital Sirio Libanes

Brasília, Brazil

ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA

Ijuí, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Brazil

SIM Centro de Investigacion Clinica

Temuco, Cautin, Chile

Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, Chile

Clinica San Carlos de Apoquindo

Santiago, Santiago Metropolitan, Chile

Anhui Provincial Hospital

Heifi, Anhui, China

Fujian Medical University - Fujian Provincial Cancer Hospital

Fuzhou, Fuijan, China

Xiamen University - The First Affiliated Hospital

Xiamen, Fujian, China

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

1Affiliated H of Sun Yat Sen U

Guangzhou, Guangdong, China

Hebei Medical Univ 4th Hosp

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhongnan univ Xiangya hosp

Changshan, Hunan, China

Jiangsu Province Hosp

Nanjing, Jiangsu, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

1st Hosp of China Medical Univ

Shenyang, Liaoning, China

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

Zhongshan Hosp Fudan Univ

Shanghai, Shanghai Municipality, China

Shanghai First People's Hosp

Shanghai, Shanghai Municipality, China

Xinjiang Medical University - Cancer Hospital

Ürümqi, Xinjiang, China

Zhejiang Medical University - Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

Peking Univ 3rd Hosp

Beijing, China

The 1st Hospital of Jilin Univ

Changchun, China

Sir Run Run Shaw Hospital

Hangzhou, China

Linyi Cancer Hospital

Linyi, China

1 Affiliated H of Nanchang U

Nanchang, China

Fudan University - Shanghai Cancer Center

Shanghai, China

CHU Besançon

Besançon, France

CHRU

Brest, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Hopital de la Timone

Marseille, France

Institut de Recherche en Cancerologie de Montpellier IRCM

Montpellier, France

Hopital Saint Antoine

Paris, France

L Institut Mutualiste Montsouris

Paris, France

Hopital Europeen G. Pompidou

Paris, France

Pharmacie ICLN

Saint-Priest-en-Jarez, France

Gustave Roussy, étage -1.

Villejuif, France

Charité-Unimedizin Berlin

Berlin, Germany

Uniklinikum Carl-Gustav-Carus

Dresden Sachsen, Germany

Evang. Klin. Essen-Mitte gGmbH

Essen, Germany

Ins. für klinische onk. Forschung

Frankfurt Am Main Hessen, Germany

Häm-Onk. Praxis Eppendorf

Hamburg, Germany

Asklepios Tumorzentrum Altona

Hamburg, Germany

Uni zu Koln-Unikl. Koln

Kln Nordrhein-westfalen, Germany

Universitares Krebszentrum

Leipzig, Germany

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong

Princess Margaret Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) - Vascular and Interventional Radiology Foundation (VIRF) Clinical Science Centre

Hong Kong, Hong Kong

Magyar Honvedseg Egeszs. K

Budapest, Hungary

Debreceni Egyetem Klinikai

Debrecen, Hungary

Tolna M. Balassa Janos Korhaz

Szekszárd, Hungary

Cork University Hospital

Cork, Ireland

Tallaght University Hospital

Dublin, Ireland

Beaumont Hospital

Dublin, Ireland

St James's Hospital

Dublin, Ireland

Soroka Univ Medical CTR

Be'er-Sheva Southern, Israel

Davidoff Center

Petah Tikva, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

AOU Pisana

Barone, Italy

IRCC-FPO Candiolo

Candiolo, Italy

AOU Mater Domini

Catanzaro, Italy

Istituto Europeo di Oncologia S.r.L Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini

Milan, Italy

Ospedale Niguarda

Milan, Italy

San Raffaele Hospital

Milan, Italy

Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Aou Vanvitelli

Naples, Italy

Istituto Oncologico Veneto

Padua, Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Aichi Cancer Center Hospital

Nagoya, Aichia, Japan

National Cancer Center Hospital

Chūōku, Japan

Osaka International Cancer Institute

Chūōku, Japan

Gifu University Hospital

Gifu, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

Kochi Health Sciences Center

Kochi, Japan

The Cancer Institute Hospital of JFCR

Kōtoku, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Kindai University Hospital

Ōsaka-sayama, Japan

Osaka University Hospital

Suita, Japan

Sklodowska-Curie Inst Oncology

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im.Mikulicza-Radeckiego

Wroclaw, Poland

Hospital Sra da Oliveira

Creixomil E Mariz, Portugal

Instituto Portugues De Oncologia Do Porto Francisco Gentil, E.P.E.

Porto, Portugal

C Hosp Tras Montes Alto Douro

Vila Real, Portugal

S.C. Oncopremium-Team SRL

Baia Mare, Romania

Institutul Oncologic Prof. Dr. Alexandru Trestiorean Bucuresti IOB

Bucharest, Romania

S.C. Medisprof SRL

Cluj-Napoca, Romania

Centrul de Oncologie Sf. Nectarie

Craiova, Romania

SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

Chelyabinsk, Russia

Private Medical Institution "Euromedservice"

Saint Petersburg, Russia

City Clinical Oncology Dispensary

Saint Petersburg, Russia

Republican Clinical Oncology Dispensary

Ufa, Russia

National Univ Cancer Inst SGP

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Kyungpook Nat Uni Chilgok Hos

Daegu, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Seoul Nati Univ Bundang Hosp

Seongnam, South Korea

Korea Univ Anam Hosp

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St. Marys Hospital

Seoul, South Korea

Chonbuk National University Hospital - Jeonbuk Regional Cancer Center

Seoul, South Korea

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Germans Trias i Pujol

Barcelona, Spain

H. Gregorio Maranon

Madrid, Spain

Hosp Univ Ramón y Cajal

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital de Navarra

Pamplona, Spain

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

H. Clinico U. de Valencia

Valencia, Spain

KMUH

Kaohsiung City, Taiwan

CGMF-Kaohsiung Branch

Kaohsiung City, Taiwan

China Medical Univ Hosp

Taichung, Taiwan

National Cheng Kung Univ Hosp

Tainan, Taiwan

National Taiwan University Hospital NTUH

Taipei, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hosp

Taipei, Taiwan

CGMF-Linkou Branch

Taoyuan District, Taiwan

SBU Adana Sehir Hastanesi

Adana, Turkey (Türkiye)

Trakya Universitesi Balkan

Edirne, Turkey (Türkiye)

Suleyman Yalcin Seh. Hast.

Istanbul, Turkey (Türkiye)

Inonu Uni. Turgut Ozal Tip

Malatya, Turkey (Türkiye)

National Cancer Institute

Kyiv, Ukraine

MedicalCenter ASKLEPION LLC

Kyiv, Ukraine

LLC "Oncolife"

Zaporizhzhia, Ukraine

University Hospitals Birmingham UHB NHS Foundation Trust - Queen Elizabeth Hospital Birmingham QEHB

Birmingham, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Velindre NHS Trust - Velindre Cancer Centre VCC

Cardiff, United Kingdom

Ninewells Hospital

Dundee, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

UCLH Trust

London, United Kingdom

Royal Marsden NHS

London, United Kingdom

Christie Hospital

Manchester, United Kingdom

University of Oxford, The Churchill Hospital

Oxford, United Kingdom

Royal Marsden Sutton

Sutton, United Kingdom

Leeds Teaching Hospitals NHS Trust

West Yorkshire, United Kingdom