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ACTIVE NOT RECRUITING
NCT05152147
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Zanidatamab

Administered IV

DRUG

Tislelizumab

Administered IV

DRUG

Trastuzumab

Administered intravenously (IV)

DRUG

Capecitabine

Administered orally (PO bid)

DRUG

Oxaliplatin

Administered IV

DRUG

Cisplatin

Administered IV

DRUG

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

And 127 more locations on ClinicalTrials.gov