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A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
Sponsor: Jazz Pharmaceuticals
Summary
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
Official title: A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
920
Start Date
2021-12-02
Completion Date
2027-09-30
Last Updated
2026-10-20
Healthy Volunteers
No
Interventions
Zanidatamab
Administered IV
Tislelizumab
Administered IV
Trastuzumab
Administered intravenously (IV)
Capecitabine
Administered orally (PO bid)
Oxaliplatin
Administered IV
Cisplatin
Administered IV
5-Fluorouracil
Administered IV
Locations (227)
Hospital de Gastroenterología Dr Bonorino Udaondo
Buenos Aires, Argentina
Instituto de Investigaciones Metabólicas - IDIM
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Fundación Centro de Medicina Nuclear y Molecular ER
Córdoba, Argentina
Centro Médico Privado CEMAIC
Córdoba, Argentina
Centro de Investigación Pergamino S.A.
Pergamino, Argentina
Centro de Investigación Clínica - Clínica Viedma
Viedma, Argentina
Flinders Medical Centre
Bedford Park, Australia
Austin Health
Heidelberg, Australia
Liverpool Hospital
Liverpool, Australia
Fiona Stanley Hospital
Murdoch, Australia
Imelda VZW
Bonheiden, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liège
Liège, Belgium
Centro Integrado de Pesquisa - CIP
Barretos, Brazil
Fundação Pio XII Hospital de Câncer de Barretos
Barretos, Brazil
Cenantron - Centro Avancado de Tratamento Oncologico Ltda
Belo Horizonte, Brazil
Centro de Pesquisas Clínicas/Fundação Doutor Amaral Carvalho
Brasília, Brazil
Instituto Do Câncer Do Ceará ICC
Fortaleza, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Hospital Nossa Senhora Da Conceição
Porto Alegre, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo
Santo André, Brazil
Instituto do Cancer do Estado de São Paulo ICESP
São Paulo, Brazil
Instituto de Oncologia de Sorocaba
Sorocaba, Brazil
Princess Margaret Cancer Centre
Toronto, Canada
Centro Internacional de Estudios Clinicos CIEC
Santiago, Region Metropolitan, Chile
Fundación Arturo López Pérez (FALP) - PPDS
Providencia, Santiago Metropolitan, Chile
Centro de Estudios Clínicos SAGA SpA
Providencia, Chile
Sociedad Oncovida S.A
Santiago, Chile
Icegclinic
Santiago, Chile
BIOCINETIC SpA
Santiago, Chile
Sociedad de Investigaciones Medicas Limitada
Temuco, Chile
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Beijing Cancer Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Beijing Luhe Hospital, Capital Medical University
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Hunan Cancer Hospital
Changsha, China
Changzhi People's Hospital
Changzhi, China
Changzhou First People's Hospital
Changzhou, China
Sichuan Cancer Hospital & Institute
Chengdu, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Fujian Cancer Hospital
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Hainan General Hospital
Haikou, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Cancer Hospital
Hefei, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Shandong Cancer Hospital
Jinan, China
Jinan Central Hospital
Jinan, China
Yunnan Cancer Hospital
Kunming, China
The First Hospital of Lanzhou University
Lanzhou, China
Gansu Cancer Hospital
Lanzhou, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Ruijin hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
Fudan University Affiliated Zhongshan Hospital
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanghai General Hospital
Shanghai, China
Liaoning Cancer Hospital & Institute
Shenyang, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Tianjin Medical University General Hospital
Tianjin, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
The Tonghua Central Hospital
Tonghua, China
Cancer Hospital affiliated to Xinjiang Medical University
Ürümqi, China
Weihai Municipal Hospital
Weihai, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Union Hospital Tongji Medical College HuaZhong University of Science and Technology
Wuhan, China
Hubei Cancer Hospital
Wuhan, China
Affiliated Hospital of Jiangnan University
Wuxi, China
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Northern Jiangsu People's Hospital
Yangzhou, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
North Estonia Medical Centre Foundation
Tallinn, Estonia
CHU de Bordeaux - Hopital Haut Leveque
Pessac, Gironde, France
Sainte-Catherine, Institut du Cancer Avignon Provence
Avignon, France
EDOG - Institut Bergonie - PPDS
Bordeaux, France
Universite de Bourgogne - Faculte de Medecine - IN
Dijon, France
Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
Grenoble, France
Centre Léon Berard
Lyon, France
EDOG Institut de Cancerologie de l'Ouest - PPDS
Nantes, France
CHRU de Poitiers La Miletrie
Poitiers, France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes, France
CHRU de Brest - Hopital Morvan
Saint-Priest-en-Jarez, France
Hôpital de Rangueil
Toulouse, France
Hôpital Saint Antoine
Villejuif, France
Research Institute of Clinical Medicine
Tbilisi, Georgia