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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
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
Trastuzumab deruxtecan
6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle
Ramucirumab
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
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