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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

2027-07-31

Last Updated

2026-03-24

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

High Technology Hospital MedCenter Ltd

Tbilisi, Georgia

Institut für Klinisch-Onkologische Forschung

Frankfurt am Main, Hesse, Germany

Attikon University General Hospital

Athens, Greece

Bioclinic Thessaloniki Oncology Department

Thessaloniki, Greece

Agios Loucas Clinic SA

Thessaloniki, Greece

Interbalkan Medical Center of Thessaloniki Oncology Department

Thessaloniki, Greece

Clinica Medica Especializada CELAN

Guatemala City, Guatemala

Grupo Medico Angeles

Guatemala City, Guatemala

Centro Medico Integral de Cancerologia CEMIC

Salcajá, Guatemala

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, India

Artemis Hospital

Gūrgaon, India

MNJ Institute of Oncology and Regional Cancer Centre

Hyderabad, India

Indraprastha Apollo Hospitals

New Delhi, India

Regional Cancer Centre Indira Gandhi Institute of Medical Sciences

Patna, India

HCG City Cancer Center

Vijayawada, India

St James's Hospital

Dublin, Ireland

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, Italy

Fondazione del Piemonte per l'Oncologia (IRCCS)

Candiolo, Italy

Ospedale Policlinico San Martino

Genova, Italy

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

Meldola, Italy

Ospedale San Raffaele S.r.l. - PPDS

Milan, Italy

Istituto Nazionale Dei Tumori

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, Italy

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Fondazione Policlinico Universitario A Gemelli

Rome, Italy

Centro Ricerche Cliniche Di Verona

Verona, Italy

Azienda ULSS 8 "Berica" - Ospedale San Bortolo

Vicenza, Italy

Chiba Cancer Center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Gifu University Hospital

Gifu, Gihu, Japan

Gunma Prefectural Cancer Center

Ota-shi, Gunma, Japan

Hyogo Cancer Center

Akashi-shi, Hyôgo, Japan

Ibaraki Prefectural Central Hospital

Kasama-Shi, Ibaraki, Japan

Kagawa University Hospital

Kita-Gun Miki-Cho, Kagawa-ken, Japan

Kanagawa Cancer Center

Yokohama-Shi Asahi-Ku, Kanagawa, Japan

Kumamoto University Hospital - Honjo-Kuhonji Campus A

Chuo-Ku, Kumamoto, Japan

Kyoto University Hospital

Sakyo-ku, Kyoto-shi, Japan

Osaki Citizen Hospital

Osaki-Shi, Miyagi, Japan

Kurashiki Central Hospital

Kurashiki-Shi, Okayama-ken, Japan

Osaka University Hospital

Suita-Shi, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-Shi, Osaka, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

National Cancer Center Hospital

Chūōku, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Saitama Cancer Center

Ina, Japan

Shikoku Cancer Center

Matsuyama, Japan

Osaka International Cancer Institute

Osaka, Japan

Kindai University Hospital

Ōsaka-sayama, Japan

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Tokyo, Japan

Hospital Pulau Pinang

George Town, Malaysia

Sarawak General Hospital

Kuching, Malaysia

National Cancer Institute ( Institut Kanser Negara)

Putrajaya, Malaysia

Health Pharma Professional Research S.A de C.V.

Mexico City, Mexico

Hospital Universitario Dr. Jose Eleuterio González

Monterrey, Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Mexico

Catharina Hospital

Eindhoven, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

ETZ-Elisabeth

Tilburg, Netherlands

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, Poland

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

Warsaw, Poland

Hospital Garcia de Orta

Almada, Portugal

Centro Hospitalar E Universitário de Coimbra EPE

Coimbra, Portugal

Hospital Senhora da Oliveira - Guimaraes, E.P.E

Guimarães, Portugal

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, Portugal

Unidade Local de Saúde de Matosinhos SA

Matosinhos Municipality, Portugal

Centro Hospitalar do Porto EPE

Porto, Portugal

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

Porto, Portugal

Fundeni Clinical Institute

Bucharest, Romania

Prof Dr I Chiricuta Institute of Oncology - PPDS

Cluj-Napoca, Romania

Medisprof SRL

Cluj-Napoca, Romania

Oncology Center Sfantul Nectarie

Craiova, Romania

University Clinical Center of Serbia - PPDS

Belgrade, Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

Oncology Institute of Vojvodina

Kamenitz, Serbia

University Clinical Center Nis

Niš, Serbia

National Cancer Center Singapore

Singapore, Singapore

Wilgers Oncology Centre

Pretoria, South Africa

Hallym University Sacred Heart Hospital

Anyang-si, South Korea

Dong-A University Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

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

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Germans Trias i Pujol

Badalona, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital Universitari de Girona Dr Josep Trueta

Girona, Spain

Institut Català d'Oncologia (Hospital Duran y Reynals)

L'Hospitalet de Llobregat, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario La Paz - PPDS

Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Spain

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

China Medical University Hospital

Taichung, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Songklanagarind Hospital

Hat Yai, Thailand

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Thailand

Chulaborn Hospital

Lak Si, Thailand

Hacettepe Universitesi Kanser Enstitusu

Ankara, Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

Dokuz Eylul Universitesi

Izmir, Turkey (Türkiye)

Acibadem Adana Hospital

Seyhan, Turkey (Türkiye)

Medical Park Trabzon Yildizli

Trabzon, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital

Yenimahalle, Turkey (Türkiye)

The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

Lutsk, Ukraine

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Western General Hospital Edinburgh - PPDS

Edinburgh, United Kingdom

St James University Hospital

Leeds, United Kingdom

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

London, United Kingdom

Royal Marsden Hospital - London

London, United Kingdom

Royal Marsden Hospital - Surrey

London, United Kingdom

Edith Cavell Hospital

Peterborough, United Kingdom

Weston Park Cancer Centre

Sheffield, United Kingdom