A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (HERIZON-GEA-01)

March 25, 2024 updated by: Jazz Pharmaceuticals

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

714

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Principal Investigator:
          • Dolores Gomez Bradley
      • Buenos Aires, Argentina, 1264
        • Recruiting
        • Hospital de Gastroenterología Dr Bonorino Udaondo
        • Principal Investigator:
          • Guillermo Mendez, MD
      • Ciudad Autónoma de Buenos Aires, Argentina, C1012
        • Recruiting
        • Instituto de Investigaciones Metabólicas - IDIM
        • Principal Investigator:
          • Martín Paskevicius, MD
      • Córdoba, Argentina, X5008HHW
        • Recruiting
        • Centro Medico Privado CEMAIC
        • Principal Investigator:
          • Jorge Salinas, MD
      • Córdoba, Argentina, X5000HXL
        • Recruiting
        • Fundación Centro de Medicina Nuclear y Molecular ER
        • Principal Investigator:
          • Aldo Riso, MD
      • Pergamino, Argentina, 2700
        • Recruiting
        • Centro de Investigacion Pergamino S.A.
        • Principal Investigator:
          • Susana Kahl, MD
      • San Miguel De Tucumán, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Médicas Tucuman
        • Principal Investigator:
          • Luisa Susana Medina, MD
      • Viedma, Argentina, R8500ACE
        • Recruiting
        • Centro de Investigación Clínica - Clínica Viedma
        • Principal Investigator:
          • Rubén Kowalyszyn, MD
  • Australia
      • Albury, Australia, 2640
        • Withdrawn
        • Border Medical Oncology Research Unit
      • Bedford Park, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Principal Investigator:
          • Amitesh Roy, MD, MSc
      • Heidelberg, Australia, 3084
        • Recruiting
        • Austin Health
        • Principal Investigator:
          • Niall Tebbutt, BA, BM, BCh, PhD
      • Liverpool, Australia, 2170
        • Recruiting
        • Liverpool Hospital
        • Principal Investigator:
          • Weng Ng, MSc, MBBS, PhD
      • Murdoch, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Principal Investigator:
          • Andrew Kiberu, MBChB
  • Belgium
      • Bonheiden, Belgium, 2820
        • Recruiting
        • Imelda VZW
        • Principal Investigator:
          • Pieter-Jan Cuyle, MD
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Principal Investigator:
          • Marc Van den Eynde, MD
      • Gent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Karen Geboes, MD
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Eric Van Cutsem, MD, PhD
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège
        • Principal Investigator:
          • Joelle Collignon, MD
  • Brazil
      • Barretos, Brazil, 14784-400
        • Recruiting
        • Fundacao Pio Xii Hospital de Cancer de Barretos
        • Principal Investigator:
          • Arinilda Campos Bragagnoli
      • Barretos, Brazil, 14784-400
        • Recruiting
        • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
        • Principal Investigator:
          • Kathia Abdalla, MD
      • Belo Horizonte, Brazil, 30130-090
        • Recruiting
        • Cenantron - Centro Avancado de Tratamento Oncologico Ltda
        • Principal Investigator:
          • Andre Murad, MD, PhD
      • Brasília, Brazil, 70840-901
        • Recruiting
        • Hospital Amaral Carvalho
        • Principal Investigator:
          • Patricia Medeiros
      • Fortaleza, Brazil, 60430-230
        • Recruiting
        • Instituto Do Câncer Do Ceará ICC
        • Principal Investigator:
          • Maria Marcela Monteiro
      • Ijuí, Brazil, 98700-000
        • Recruiting
        • Associação Hospital de Caridade Ijuí
        • Principal Investigator:
          • Fabio Franke, MD
      • Porto Alegre, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceicao
        • Principal Investigator:
          • Juliana Janoski de Menezes, MD
      • Porto Alegre, Brazil, 90050-170
        • Recruiting
        • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
        • Principal Investigator:
          • Rodrigo Perez Pereira, MD
      • Porto Alegre, Brazil, 90050-170
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
        • Principal Investigator:
          • Katsuki Arima Tiscoski, MD
      • Porto Alegre, Brazil, 90610-000
        • Recruiting
        • Hospital São Lucas da PUCRS
        • Principal Investigator:
          • Luciana Viola, MD
      • Rio De Janeiro, Brazil, 20231-050
        • Recruiting
        • INCA - Instituto Nacional de Câncer José Alencar G
        • Principal Investigator:
          • Cristiano Duque, MD
      • Santo André, Brazil, 09060-650
        • Recruiting
        • Instituto Brasileiro de Controle do Cancer Ibcc
        • Principal Investigator:
          • Felipe Jose Silva Melo Cruz, MD
      • Sorocaba, Brazil, 18030-075
        • Recruiting
        • Instituto de Oncologia de Sorocaba
        • Principal Investigator:
          • Luis Pires, MD, PhD
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • Instituto do Cancer do Estado de São Paulo ICESP
        • Principal Investigator:
          • Camila Moniz, MD
  • Canada
      • Toronto, Canada, M5G 2C1
        • Recruiting
        • Princess Margaret Cancer Centre
        • Principal Investigator:
          • Elena Elimova, MD
  • Chile
      • Osorno, Chile, 5290000
        • Completed
        • Corporacion de Beneficencia Osorno
      • Providencia, Chile, 7500000
        • Recruiting
        • Centro de Estudios Clínicos SAGA SpA
        • Principal Investigator:
          • Ariel Zwenger, MD
      • Providencia, Chile
        • Not yet recruiting
        • Research Site
      • Recoleta, Chile, 8420000
        • Recruiting
        • Meditek Ltda
        • Principal Investigator:
          • Mauricio Reyes, MD
      • Santiago, Chile, 7500000
        • Recruiting
        • Sociedad Oncovida S.A
        • Principal Investigator:
          • Pamela Salman, MD
      • Santiago, Chile, 8150513
        • Recruiting
        • Icegclinic
        • Principal Investigator:
          • Anrried Escalante, MD
      • Santiago, Chile, 8330336
        • Recruiting
        • BIOCINETIC SpA
        • Principal Investigator:
          • Marco Bernaschina Olivares, MD
      • Temuco, Chile, 4810469
        • Recruiting
        • Sociedad de Investigaciones Medicas Limitada
        • Principal Investigator:
          • Patricio Yanez Weber, MD
  • China
      • Beijing, China, 100142
        • Active, not recruiting
        • Beijing Cancer Hospital
      • Beijing, China, 100730
        • Active, not recruiting
        • Beijing Hospital
      • Beijing, China, 100730
        • Withdrawn
        • Peking Union Medical College Hospital
      • Beijing, China, 100020
        • Active, not recruiting
        • Beijing Chao-Yang Hospital, Capital Medical University
      • Beijing, China, 100021
        • Active, not recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, China, 100191
        • Active, not recruiting
        • Peking University Third Hospital
      • Beijing, China, 101199
        • Active, not recruiting
        • Beijing Luhe Hospital, Capital Medical University
      • Beijing, China, 100050
        • Terminated
        • Beijing Tiantan Hospital, Capital Medical University
      • Bengbu, China, 233004
        • Active, not recruiting
        • The First Affiliated Hospital of Bengbu Medical College
      • Changsha, China, 410031
        • Active, not recruiting
        • Hunan Cancer Hospital
      • Changzhi, China, 046099
        • Active, not recruiting
        • Changzhi People Hospital
      • Changzhou, China, 213004
        • Active, not recruiting
        • The First People's Hospital of Changzhou
      • Chengdu, China, 610042
        • Active, not recruiting
        • Sichuan Cancer Hospital & Institute
      • Foshan, China, 528000
        • Withdrawn
        • Foshan First People's Hospital
      • Fuzhou, China, 350005
        • Active, not recruiting
        • The First Affiliated Hospital of Fujian Medical University
      • Fuzhou, China, 350014
        • Active, not recruiting
        • Fujian Cancer Hospital
      • Guangzhou, China, 510055
        • Active, not recruiting
        • Guangdong Provincial People's Hospital
      • Guangzhou, China, 510655
        • Active, not recruiting
        • The Sixth Affiliated Hospital of Sun Yat-Sen University
      • Haikou, China, 570311
        • Active, not recruiting
        • Hainan General Hospital
      • Hangzhou, China, 310003
        • Active, not recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Hangzhou, China, 310016
        • Active, not recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, China, 310017
        • Active, not recruiting
        • Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, China, 310022
        • Active, not recruiting
        • Zhejiang Cancer Hospital
      • Harbin, China, 150081
        • Active, not recruiting
        • Harbin Medical University Cancer Hospital
      • Hefei, China, 230031
        • Active, not recruiting
        • Anhui Provincial Cancer Hospital
      • Hefei, China, 230601
        • Active, not recruiting
        • The Second Affiliated Hospital of Anhui Medical University
      • Hohhot, China, 01000
        • Active, not recruiting
        • Affiliated Hospital of Inner Mongolia Medical University
      • Jinan, China, 250000
        • Active, not recruiting
        • Shandong Cancer Hospital
      • Jinan, China, 250013
        • Active, not recruiting
        • Jinan Cancer Hospital
      • Kunming, China, 650118
        • Active, not recruiting
        • Yunnan Cancer Hospital
      • Lanzhou, China, 730013
        • Active, not recruiting
        • The First Hospital of Lanzhou University
      • Lanzhou, China, 730050
        • Active, not recruiting
        • Gansu Provincial Cancer Hospital
      • Nanchang, China, 330052
        • Active, not recruiting
        • The First Affiliated Hospital of Nanchang University
      • Nanjing, China, 210008
        • Active, not recruiting
        • Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School
      • Qingdao, China, 266003
        • Active, not recruiting
        • The Affiliated Hospital of Qingdao University
      • Shanghai, China, 200032
        • Active, not recruiting
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200120
        • Withdrawn
        • Shanghai East Hospital
      • Shanghai, China, 200025
        • Active, not recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
      • Shanghai, China, 200032
        • Active, not recruiting
        • Fudan University Affiliated Zhongshan Hospital
      • Shanghai, China, 200072
        • Active, not recruiting
        • Shanghai 10th People's Hospital
      • Shanghai, China
        • Active, not recruiting
        • Research Site 1
      • Shanghai, China
        • Active, not recruiting
        • Research Site 2
      • Shanghai, China, 200080
        • Active, not recruiting
        • Shanghai General Hospital
      • Shangrao, China, 334000
        • Active, not recruiting
        • Shangrao People's Hospital
      • Shenyang, China, 110001
        • Active, not recruiting
        • The First Hospital of China Medical University
      • Shenyang, China, 110801
        • Active, not recruiting
        • LiaoNing Cancer Hospital & Institute
      • Shenzhen, China, 518035
        • Active, not recruiting
        • Peking University Shenzhen Hospital
      • Shenzhen, China
        • Active, not recruiting
        • Research Site
      • Shenzhen, China, 518001
        • Withdrawn
        • Shenzehen People's Hospital
      • Shijiazhuang, China, 50011
        • Active, not recruiting
        • The Fourth Hospital of Hebei Medical University
      • Tianjin, China, 300041
        • Active, not recruiting
        • Tianjin Medical University General Hospital
      • Tianjin, China, 300060
        • Active, not recruiting
        • Tianjin Medical University Cancer Institute & Hospital
      • Tonghua, China, 143099
        • Active, not recruiting
        • The Tonghua Central Hospital
      • Weihai, China, 264200
        • Active, not recruiting
        • Weihai Municipal Hospital
      • Wenzhou, China, 325000
        • Active, not recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China, 430023
        • Active, not recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, China, 430079
        • Active, not recruiting
        • Hubei Cancer Hospital
      • Wuxi, China, 214062
        • Active, not recruiting
        • Affiliated Hospital of Jiangnan University
      • Xi'an, China, 710061
        • Active, not recruiting
        • First Affiliated Hospital of Xi 'an Jiaotong University
      • Xiamen, China, 361003
        • Active, not recruiting
        • The First Affiliated hospital of Xiamen University
      • Yangzhou, China, 225001
        • Active, not recruiting
        • Northern Jiangsu People's Hospital
      • Zhengzhou, China, 450003
        • Active, not recruiting
        • Henan Cancer Hospital
      • Zhengzhou, China, 450052
        • Active, not recruiting
        • The First Affiliated Hospital of Zhengzhou University
      • Ürümqi, China, 830026
        • Active, not recruiting
        • Cancer Hospital affiliated to Xinjiang Medical University
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Withdrawn
        • Fakultní Nemocnice Olomouc
  • Estonia
      • Tallinn, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre Foundation
        • Principal Investigator:
          • Niina Kippasto, MD
      • Tallinn, Estonia, 11312
        • Recruiting
        • East Tallinn Central Hospital
        • Principal Investigator:
          • Vivian Esko, MD
  • France
      • Avignon, France, 84000
        • Recruiting
        • Institut Sainte Catherine
        • Principal Investigator:
          • Clémence TOULLEC, MD
      • Besançon, France, 25030
        • Recruiting
        • Hôpital Jean Minjoz
        • Principal Investigator:
          • Christophe Borg, MD, PhD
      • Bordeaux, France, 33000
        • Recruiting
        • EDOG - Institut Bergonie - PPDS
        • Principal Investigator:
          • Simon Pernot, MD
      • Dijon, France, 21079
        • Recruiting
        • Universite de Bourgogne - Faculte de Medecine - IN
        • Principal Investigator:
          • François Ghiringhelli, MD
      • Grenoble, France, 38043
        • Recruiting
        • Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
        • Principal Investigator:
          • Gael ROTH, MD
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon Bérard
        • Principal Investigator:
          • christelle De la Fouchardiere, MD
      • Nantes, France, 44805
        • Recruiting
        • EDOG Institut de Cancerologie de l'Ouest - PPDS
        • Principal Investigator:
          • Judith Raimbourg, MD
      • Poitiers, France, 86021
        • Recruiting
        • CHRU de Poitiers La Miletrie
        • Principal Investigator:
          • David TOUGERON, MD
      • Rennes, France, 35000
        • Recruiting
        • EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
        • Principal Investigator:
          • Samuel Le Sourd, MD
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • CHRU de Brest - Hopital Morvan
        • Principal Investigator:
          • Jean-Philippe Metges, MD
      • Toulouse, France, 69437
        • Recruiting
        • Hôpital de Rangueil
        • Principal Investigator:
          • Rosine Guimbaud
      • Villejuif, France, 94800
        • Recruiting
        • Hôpital Saint Antoine
        • Principal Investigator:
          • Romain Cohen, MD
  • Georgia
      • Tbilisi, Georgia, 0112
        • Recruiting
        • Research Institute of Clinical Medicine
        • Principal Investigator:
          • Tamar Melkadze, MD
      • Tbilisi, Georgia, 0112
        • Recruiting
        • LTD TIM, Tbilisi Institute of Medicine
        • Principal Investigator:
          • Mariam Gogishvili, MD
      • Tbilisi, Georgia, 0144
        • Recruiting
        • Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
        • Principal Investigator:
          • Miranda Gogishvili, MD
      • Tbilisi, Georgia, 6000
        • Recruiting
        • High Technology Hospital MedCenter Ltd
        • Principal Investigator:
          • Tamta Makharadze, MD
  • Germany
      • Frankfurt am Main, Germany
        • Not yet recruiting
        • Research Site
      • Hannover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Arndt Vogel, MD
      • Leipzig, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig
        • Principal Investigator:
          • Florian Lordick, MD
      • Trier, Germany
        • Not yet recruiting
        • Research Site
      • Ulm, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
        • Principal Investigator:
          • Thomas Ettrich, MD
  • Greece
      • Athens, Greece, 115 28
        • Recruiting
        • Aretaieio Hospital of Athens
        • Principal Investigator:
          • Christos Papadimitriou, MD
      • Athens, Greece, 124 64
        • Recruiting
        • Attikon University General Hospital
        • Principal Investigator:
          • Amanda Psyrri, MD
      • Piraeus, Greece
        • Not yet recruiting
        • Research Site
      • Thessaloniki, Greece, 54622
        • Recruiting
        • Bioclinic Thessaloniki Oncology Department
        • Principal Investigator:
          • Ioannis Boukovinas, MD, PhD, PharmD
      • Thessaloniki, Greece, 552 36
        • Recruiting
        • Agios Loucas Clinic SA
        • Principal Investigator:
          • Ippokratis Korantzis
      • Thessaloniki, Greece, 57001
        • Recruiting
        • Interbalkan Medical Center of Thessaloniki Oncology Department
        • Principal Investigator:
          • Sofia Baka, MD
    • Attiki
      • Peiraias, Attiki, Greece, 185 37
        • Withdrawn
        • Metaxa Memorial Cancer Hospital Piraeus Dept. οf Medical Oncology
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Recruiting
        • Celan S.A.
        • Principal Investigator:
          • Agatha Mireya Reyes Morales, MD
      • Guatemala City, Guatemala, 01010
        • Recruiting
        • INTEGRA Cancer Institute
        • Principal Investigator:
          • Pier Anyelo Ramos Elías, MD
      • Guatemala City, Guatemala, 01015
        • Recruiting
        • Grupo Medico Angeles
        • Principal Investigator:
          • Hugo Castro, MD
      • Salcaja, Guatemala, 09002
        • Recruiting
        • Centro Medico Integral de Cancerologia CEMIC
        • Principal Investigator:
          • Marco Chivalan, MD
  • India
      • Bangalore, India, 560068
        • Recruiting
        • The Bangalore Hospital
        • Principal Investigator:
          • Rajeev Krishnappa, MD
      • Bhubaneswar, India, 751019
        • Recruiting
        • All India Institute of Medical Sciences, Bhubaneswar
        • Principal Investigator:
          • Saroj Das Majumdar, MD
      • Gurgaon, India, 122003
        • Recruiting
        • Artemis hospital
        • Principal Investigator:
          • Vineet Gupta, MD
      • Hyderabad, India, 500004
        • Recruiting
        • MNJ Institute of Oncology and Regional Cancer Centre
        • Principal Investigator:
          • Srinivasulu Mukta, MD
      • Jaipur, India
        • Not yet recruiting
        • Research Site
      • Nashik, India, 422002
        • Recruiting
        • Curie Manavata Cancer Centre
        • Principal Investigator:
          • Rajnish Nagarkar, MD
      • New Delhi, India, 110076
        • Recruiting
        • Indraprastha Apollo Hospitals
        • Principal Investigator:
          • Manish Singhal, DM, MD
      • Patna, India, 800014
        • Recruiting
        • Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
        • Principal Investigator:
          • Rajesh Kumar Singh
      • Pune, India, 411006
        • Recruiting
        • Deenanath Mangeshkar Hospital and Research Centre
        • Principal Investigator:
          • Chetan Deshmukh, DM, DMD, DN, MBBS, MD
      • Vijayawada, India, 520002
        • Recruiting
        • HCG City Cancer Center
        • Principal Investigator:
          • Gopichand Mamillapalli, MD
  • Ireland
      • Dublin, Ireland, 8
        • Recruiting
        • St James's Hospital
        • Principal Investigator:
          • Maeve Lowery
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
        • Principal Investigator:
          • Karim Rihawi, MD
      • Candiolo, Italy, 10060
        • Recruiting
        • Fondazione del Piemonte per l'Oncologia (IRCCS)
        • Principal Investigator:
          • Elisabetta Fenocchio, MD
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino
        • Principal Investigator:
          • Annamaria Pessino, MD
      • Meldola, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
        • Principal Investigator:
          • Giovanni Luca Frassineti, MD
      • Milano, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
        • Principal Investigator:
          • Salvatore Siena, MD
      • Milano, Italy, 20133
        • Recruiting
        • Istituto Nazionale dei Tumori
        • Principal Investigator:
          • Filippo Pietrantonio, MD
      • Milano, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
        • Principal Investigator:
          • Elena Mazza, MD
      • Modena, Italy, 41124
        • Recruiting
        • Azienda Ospedaliero Universitaria Di Modena Policlinico
        • Principal Investigator:
          • Andrea Spallanzani, MD
      • Reggio Emilia, Italy, 43100
        • Recruiting
        • Arcispedale Santa Maria Nuova
        • Principal Investigator:
          • Carmine Pinto, MD
      • Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A Gemelli
        • Principal Investigator:
          • Giampaolo Tortora, MD
      • Torino, Italy, 10126
        • Recruiting
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
        • Principal Investigator:
          • Libero Ciuffreda, MD
      • Verona, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche Di Verona
        • Principal Investigator:
          • Davide Melisi, MD
      • Vicenza, Italy, 36100
        • Recruiting
        • Azienda ULSS 8 "Berica" - Ospedale San Bortolo
        • Principal Investigator:
          • Giuseppe Aprile, MD
  • Japan
      • Chuo Ku, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Principal Investigator:
          • Hidekazu Hirano, MD
      • Fukuoka-shi, Japan, 811-1395
        • Not yet recruiting
        • National Hospital Organization Kyushu Cancer Center
        • Principal Investigator:
          • Komoda, MD
      • Ina, Japan, 362-0806
        • Recruiting
        • Saitama Cancer Center
        • Principal Investigator:
          • Hiroki Hara
      • Matsuyama, Japan, 791-0245
        • Recruiting
        • Shikoku Cancer Center
        • Principal Investigator:
          • Tomohiro Nishina, MD
      • Nagoya shi, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center
        • Principal Investigator:
          • Yukiya Narita, MD
      • Osaka, Japan, 540-0008
        • Recruiting
        • Osaka International Cancer Institute
        • Principal Investigator:
          • Toshihiro Kudo, MD
      • Osaka-sayama, Japan, 589-0014
        • Recruiting
        • Kindai University Hospital
        • Principal Investigator:
          • Hisato Kawakami, MD
      • Shizuoka, Japan, 411-0934
        • Recruiting
        • Shizuoka Cancer Center
        • Principal Investigator:
          • Takeshi Kawakami, MD
      • Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
        • Principal Investigator:
          • Kensei Yamaguchi, MD
    • Gihu
      • Gifu-Shi, Gihu, Japan, 501-1112
        • Recruiting
        • Gifu University Hospital
        • Principal Investigator:
          • Nobuhisa Matsuhashi
    • Gunma
      • Ota-shi, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center
        • Principal Investigator:
          • Hisashi Hosaka
    • Hukui
      • Fukui-shi, Hukui, Japan, 910-8526
        • Recruiting
        • Fukui Prefectural Hospital
        • Principal Investigator:
          • Tamon Miyanaga
    • Hyôgo
      • Akashi-shi, Hyôgo, Japan, 673-8558
        • Recruiting
        • Hyogo Cancer Center
        • Principal Investigator:
          • Masahiro Tsuda
      • Kobe-Shi Chuo-Ku, Hyôgo, Japan, 650-0047
        • Not yet recruiting
        • Kobe City Medical Center General Hospital
        • Principal Investigator:
          • Yasui, MD
    • Ibaraki
      • Kasama-Shi, Ibaraki, Japan, 309-1793
        • Not yet recruiting
        • Ibaraki Prefectural Central Hospital
        • Principal Investigator:
          • Amagai, MD
    • Kagawa
      • Kita-Gun Miki-Cho, Kagawa, Japan, 761-0701
        • Recruiting
        • Kagawa University Hospital
        • Principal Investigator:
          • Akihito Tsuji
    • Kanagawa
      • Yokohama-Shi Asahi-Ku, Kanagawa, Japan, 241-0815
        • Not yet recruiting
        • Kanagawa cancer center
        • Principal Investigator:
          • Machida, MD
      • Yokohama-Shi Minami-Ku, Kanagawa, Japan, 232-0006
        • Recruiting
        • Kitasato University Hospital
        • Principal Investigator:
          • Kenji Ishido
    • Kumamoto
      • Chuo-Ku, Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital - Honjo-Kuhonji Campus A
        • Principal Investigator:
          • Kojiro Eto
    • Kyoto-shi
      • Sakyo-ku, Kyoto-shi, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
        • Principal Investigator:
          • Takako Nakajima, MD
    • Miyagi
      • Osaki-Shi, Miyagi, Japan, 989-6136
        • Recruiting
        • Osaki Citizen Hospital
        • Principal Investigator:
          • Yasuhiro Sakamoto
    • Okayama
      • Kurashiki-Shi, Okayama, Japan, 710-0052
        • Recruiting
        • Kurashiki Central Hospital
        • Principal Investigator:
          • Shinichi Nishina
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
        • Principal Investigator:
          • Shogen Boku
      • Suita-Shi, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
        • Principal Investigator:
          • Taroh Satoh, MD
      • Takatsuki-Shi, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Principal Investigator:
          • Toshifumi Yamaguchi
    • Tiba
      • Chiba-Shi, Tiba, Japan, 260-0801
        • Not yet recruiting
        • Chiba cancer center
        • Principal Investigator:
          • Minashi, MD
      • Kashiwa-shi, Tiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Principal Investigator:
          • Kohei Shitara, MD
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Not yet recruiting
        • Keio University Hospital
        • Principal Investigator:
          • Kenro Hirata
  • Korea, Republic of
      • Anyang-si, Korea, Republic of, 14068
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Principal Investigator:
          • Dae Young Zang
      • Busan, Korea, Republic of, 49201
        • Recruiting
        • Dong-A University Hospital
        • Principal Investigator:
          • Sung Yong Oh, MD, PhD
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Jong Gwang Kim
      • Goyang-si, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
        • Principal Investigator:
          • Young Lee Park, MD, PhD
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Sun-Jin Sym, MD
      • Seongnam-si, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Keun-Wook Lee, MD
      • Seongnam-si, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center, CHA University
        • Principal Investigator:
          • Beodeul Kang, PhD
      • Seoul, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Principal Investigator:
          • Sang Cheul Oh, MD, PhD
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Do-Youn Oh, MD
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Yoon-Koo Kang, MD
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Won Ki Kang, MD
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Jwa Hoon Kim, MD, PhD
      • Seoul, Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital
        • Principal Investigator:
          • Dong-Hoe Koo, MD
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Principal Investigator:
          • Inho Kim, MD, PhD
      • Seoul, Korea, Republic of, 03686
        • Recruiting
        • Severance Hospital Yonsei University Health System - PPDS
        • Principal Investigator:
          • Sun Young Rha, MD, PhD
      • Seoul, Korea, Republic of, 06229
        • Recruiting
        • Gangnam Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Hei-Cheul Jeung, MD, PhD
  • Malaysia
      • George Town, Malaysia, 10990
        • Recruiting
        • Hospital Pulau Pinang
        • Principal Investigator:
          • Chin Heng Fong, MD
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
        • Principal Investigator:
          • Wan Zamaniah Wan Ishak, MD
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Pantai Hospital Kuala Lumpur
        • Principal Investigator:
          • Kai Seng Lam, MBBS
      • Kuching, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital
        • Principal Investigator:
          • Pei Jye Voon
      • Putrajaya, Malaysia, 62675
        • Recruiting
        • National Cancer Institute ( Institut Kanser Negara)
        • Principal Investigator:
          • Norhidayu Binti Salimin
  • Mexico
      • Mexico City, Mexico, 06100
        • Recruiting
        • Cryptex Investigación Clínica, S.A. de C.V.
        • Principal Investigator:
          • Daniel Motola, MD
      • Mexico City, Mexico
        • Not yet recruiting
        • Research Site 2
      • Mexico City, Mexico, 14080
        • Recruiting
        • Clinstile, S.A. de C.V.
        • Principal Investigator:
          • Vanessa Rosas
      • Monterrey, Mexico, 64460
        • Recruiting
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
        • Principal Investigator:
          • Victor Manuel Oyervides Juarez, MD
      • Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca
        • Principal Investigator:
          • Roberto Romero Diaz
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Recruiting
        • Catharina Hospital
        • Principal Investigator:
          • Geert Creemers, MD
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Principal Investigator:
          • Jacco de Haan, MD
      • Leiden, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum
        • Principal Investigator:
          • Marije Slingerland, MD
      • Tilburg, Netherlands, 5042 AD
        • Recruiting
        • ETZ-Elisabeth
        • Principal Investigator:
          • Robbert van Alphen, MD
  • Poland
      • Skórzewo, Poland, 60-185
        • Recruiting
        • Centrum Medyczne Poznan - PRATIA - PPDS
        • Principal Investigator:
          • Piotr Tomczak, MD, PhD
      • Łódź, Poland, 93-513
        • Recruiting
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
        • Principal Investigator:
          • Malgorzata Ulanska, MD
  • Portugal
      • Almada, Portugal, 2801-951
        • Recruiting
        • Hospital Garcia de Orta
        • Principal Investigator:
          • Helder Mansinho, MD
      • Coimbra, Portugal, 3000-459
        • Recruiting
        • Centro Hospitalar e Universitario de Coimbra EPE
        • Principal Investigator:
          • Jorge Manuel Ferreira Cruz, MD
      • Guimarães, Portugal, 4830-044
        • Recruiting
        • Hospital Senhora da Oliveira - Guimaraes, E.P.E
        • Principal Investigator:
          • Carolina Carvalho
      • Lisboa, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
        • Principal Investigator:
          • Cecília Alvim
      • Loures, Portugal, 2674-514
        • Recruiting
        • Hospital Beatriz Angelo
        • Principal Investigator:
          • Fábio Lopes
      • Matosinhos, Portugal, 4454-509
        • Recruiting
        • Unidade Local de Saúde de Matosinhos SA
        • Principal Investigator:
          • Helena Magalhães, MD
      • Porto, Portugal, 4099-001
        • Recruiting
        • Centro Hospitalar do Porto EPE
        • Principal Investigator:
          • Sergio Azevedo, MD
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
        • Principal Investigator:
          • Filipa Carneiro
  • Romania
      • București, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute
        • Principal Investigator:
          • Adina Croitoru, MD
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Cardiomed SRL
        • Principal Investigator:
          • Calin Cainap, MD
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Prof Dr I Chiricuta Institute of Oncology - PPDS
        • Principal Investigator:
          • Tudor Ciuleanu, MD
      • Cluj-Napoca, Romania, 400641
        • Recruiting
        • Medisprof srl
        • Principal Investigator:
          • Anghel Adrian Udrea, MD
      • Craiova, Romania, 200094
        • Recruiting
        • Onco Clinic Consult SA
        • Principal Investigator:
          • Patricia Visan, MD
      • Craiova, Romania, 200347
        • Recruiting
        • Oncology Center Sfantul Nectarie
        • Principal Investigator:
          • Michael Schenker, MD
      • Iasi, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie Iasi
        • Principal Investigator:
          • Bogdan Gafton, MD
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Military Medical Academy
        • Principal Investigator:
          • Zoran Petrovic, MD
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia - PPDS
        • Principal Investigator:
          • Nenad Mijalkovic, MD
      • Belgrade, Serbia, 11070
        • Recruiting
        • Clinical Hospital Center Bezanijska kosa
        • Principal Investigator:
          • Zoran Andric, MD
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute for Oncology and Radiology of Serbia - PPDS
        • Principal Investigator:
          • Davorin Radosavljevic, MD
      • Niš, Serbia, 18000
        • Recruiting
        • University Clinical Center Nis
        • Principal Investigator:
          • Miljana Dzunic
      • Sremska Kamenica, Serbia, 21204
        • Recruiting
        • Oncology Institute of Vojvodina
        • Principal Investigator:
          • Ivan Nikolic, MD
  • Singapore
      • Singapore, Singapore, 329563
        • Recruiting
        • Curie Oncology
        • Principal Investigator:
          • Su Pin Choo
      • Singapore, Singapore, 119074
        • Recruiting
        • Oncocare Cancer Centre
        • Principal Investigator:
          • Thomas Soh
      • Singapore, Singapore, 258500
        • Recruiting
        • National Cancer Center Singapore
        • Principal Investigator:
          • Matthew Chau-Hsien, MD
  • South Africa
      • Cape Town, South Africa, 7570
        • Recruiting
        • Cape Town Oncology Trials
        • Principal Investigator:
          • Conrad Jacobs, MD
      • Mogale City, South Africa, 1724
        • Withdrawn
        • Southern Cross Research South Africa (PTY) LTD
      • Pretoria, South Africa, 0181
        • Recruiting
        • University Of Pretoria
        • Principal Investigator:
          • Richard Khanyile
      • Pretoria, South Africa, 0184
        • Recruiting
        • Wilgers Oncology Centre
        • Principal Investigator:
          • Samuel Fourie, MBBS, MD
  • Spain
      • Badalona, Spain, 8915
        • Recruiting
        • Hospital Universitario Germans Trias i Pujol
        • Principal Investigator:
          • Cinta Hierro Carbo, MD
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
        • Principal Investigator:
          • Josep Tabernero Caturla, MD, PhD
      • Girona, Spain, 17007
        • Recruiting
        • Hospital Universitari de Girona Dr Josep Trueta
        • Principal Investigator:
          • Raquel Guardeño, MD
      • L'Hospitalet de Llobregat, Spain, 08908
        • Recruiting
        • ICO l'Hospitalet - Hospital Duran i Reynals
        • Principal Investigator:
          • Mariona Calvo Campos, MD
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Federico Longo Muñoz, MD
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz - PPDS
        • Principal Investigator:
          • Ana Belén Custodio Carretero, MD
      • Madrid, Spain, 28041
        • Withdrawn
        • Hospital Universitario 12 de Octubre
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga - Hospital General
        • Principal Investigator:
          • Inmaculada Ales, MD
      • Salamanca, Spain, 32911
        • Recruiting
        • Complejo Asistencial Universitario de Salamanca - H. Clinico
        • Principal Investigator:
          • Rosario Vidal Tocino, MD
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Principal Investigator:
          • Fernando Rivera Herrero, MD, PhD
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Principal Investigator:
          • Juan José Reina Zoilo
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Principal Investigator:
          • Tania Fleitas, MD
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Principal Investigator:
          • Roberto Antonio Pazo Cid, MD
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Corporacio Sanitaria Parc Tauli
        • Principal Investigator:
          • Ismael Macías Declara, MD
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Principal Investigator:
          • Virginia Arrazubi Arrula, MD
  • Taiwan
      • Taichung, Taiwan, 404472
        • Recruiting
        • China Medical University Hospital
        • Principal Investigator:
          • Li-Yuan Bai
      • Tainan, Taiwan, 71004
        • Recruiting
        • Chi Mei Medical Center
        • Principal Investigator:
          • Chien-Tai Huang
      • Taipei, Taiwan, 104
        • Recruiting
        • Mackay Memorial Hospital
        • Principal Investigator:
          • Johnson Lin
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Ming-Huang Chen
  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Phramongkutklao Hospital
        • Principal Investigator:
          • Naiyarat Prasongsook
      • Bangkok, Thailand, 10300
        • Recruiting
        • Bangkok Metropolitan Administration Medical College and Vajira Hospital
        • Principal Investigator:
          • Yotsawaj Runglodvatana
      • Bangkok Noi, Thailand, 10700
        • Recruiting
        • Siriraj Hospital Mahidol University
        • Principal Investigator:
          • Nopadol Soparattanapaisarn, MD
      • Hat Yai, Thailand, 90110
        • Recruiting
        • Prince of Songkla University
        • Principal Investigator:
          • Chirawadee Sathitruangsak
      • Khon Kaen, Thailand, 40000
        • Recruiting
        • Srinagarind Hospital, Khon Kaen University
        • Principal Investigator:
          • Jarin Chindaprasirt
      • Lak Si, Thailand, 10210
        • Recruiting
        • Chulaborn Hospital
        • Principal Investigator:
          • Archara Supavavej
      • Phitsanulok, Thailand, 65000
        • Recruiting
        • Naresuan University
        • Principal Investigator:
          • Wittawat Jitpewngarm, MD
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universitesi Kanser Enstitusu
        • Principal Investigator:
          • Suayib Yalcin, MD
      • Antalya, Turkey, 07300
        • Recruiting
        • Antalya Yaşam Onkoloji Merkezi
        • Principal Investigator:
          • Hasan Coskun, MD
      • Antalya, Turkey, 07070
        • Recruiting
        • Akdeniz University Medical Faculty
        • Principal Investigator:
          • Sema Sezgin Goksu
      • Balçova, Turkey
        • Not yet recruiting
        • Research Site
      • Bursa, Turkey, 16059
        • Recruiting
        • Uludag Universites Tip Fakultesi Hastanesi
        • Principal Investigator:
          • Turkkan Evrensel
      • Denizli, Turkey
        • Not yet recruiting
        • Research Site
      • Diyarbakir, Turkey, 21100
        • Recruiting
        • Dicle University Medical Faculty
        • Principal Investigator:
          • Muhammet Ali kaplan
      • Edirne, Turkey, 22030
        • Recruiting
        • Trakya University Medical Faculty
        • Principal Investigator:
          • Bulent Erdogan
      • Fatih, Turkey
        • Not yet recruiting
        • Research Site
      • Izmir, Turkey, 35220
        • Recruiting
        • Dokuz Eylul Universitesi
        • Principal Investigator:
          • Tugba Yavuzsen
      • Sariyer, Turkey, 34457
        • Recruiting
        • Acibadem Maslak Hospital
        • Principal Investigator:
          • Atakan Demir
      • Seyhan, Turkey, 01130
        • Recruiting
        • Acibadem Adana Hospital
        • Principal Investigator:
          • Umut Disel, MD
      • Sur, Turkey
        • Not yet recruiting
        • Research Site
      • Tarabya, Turkey
        • Not yet recruiting
        • Research Site
      • Trabzon, Turkey, 61310
        • Recruiting
        • Medical Park Trabzon Yildizli
        • Principal Investigator:
          • Halil Kavgaci
      • Yenimahalle, Turkey
        • Not yet recruiting
        • Research Site
      • Çankaya, Turkey
        • Not yet recruiting
        • Research Site
    • Istanbul
      • Fatih, Istanbul, Turkey, 34098
        • Not yet recruiting
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi
        • Principal Investigator:
          • Ozguroglu, MD
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Active, not recruiting
        • Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
      • Kharkiv, Ukraine, 61070
        • Withdrawn
        • Communal Non-profit Enterprise Regional Center of Oncology
      • Kryvyi Rih, Ukraine, 50048
        • Active, not recruiting
        • MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
      • Kyiv, Ukraine, 03039
        • Withdrawn
        • Medical Center of Limited Liability Company "Medical center "VERUM EXPERT"
      • Kyiv, Ukraine, 03126
        • Withdrawn
        • Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima
      • Kyiv, Ukraine, 03680
        • Withdrawn
        • SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine
      • Kyiv, Ukraine, 3115
        • Withdrawn
        • Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center
      • Lutsk, Ukraine, 43018
        • Active, not recruiting
        • The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
      • Odesa, Ukraine, 65055
        • Active, not recruiting
        • Municipal Non-profit Enterprise "Odessa Regional Oncology Dispensary" of Odesa RC
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre
        • Principal Investigator:
          • Stephen Falk, MBBS, MD
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital Edinburgh - PPDS
        • Principal Investigator:
          • Lucy Wall, MD
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James University Hospital
        • Principal Investigator:
          • Danny Ulahannan
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
        • Principal Investigator:
          • Nicholas Maisey
      • London, United Kingdom, SW7 3RP
        • Recruiting
        • Royal Marsden Hospital - London
        • Principal Investigator:
          • David Cunningham, MD
      • London, United Kingdom, SW7 3RP
        • Recruiting
        • Royal Marsden Hospital - Surrey
        • Principal Investigator:
          • David Cunningham, MD
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Hospital
        • Principal Investigator:
          • Mark Harrison, MD
      • Peterborough, United Kingdom, PE3 9GZ
        • Recruiting
        • Edith Cavell Hospital
        • Principal Investigator:
          • Sarah Ayers, MD
      • Sheffield, United Kingdom, S10 2SJ
        • Recruiting
        • Weston Park Cancer Centre
        • Principal Investigator:
          • Suzanne Darby, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment
  • Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
  • Adequate organ function
  • Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)

Exclusion Criteria:

  • Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEA
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unresectable locally advanced, recurrent or metastatic GEA
  • Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)
  • Known history of or ongoing leptomeningeal disease (LMD)
  • Known additional malignancy that is not considered cured or that has required treatment within the past 3 years
  • Known active hepatitis
  • Any history of human immunodeficiency virus (HIV) infection
  • Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible
  • QTc Fridericia (QTcF) > 470 ms
  • Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Drug: Cisplatin
Administered IV
Drug: Trastuzumab
Administered intravenously (IV)
Other Names:
  • Herceptin®
Drug: Capecitabine
Administered orally (PO bid)
Drug: Oxaliplatin
Administered IV
Drug: 5-Fluorouracil
Administered IV
Experimental: Arm B
Zanidatamab plus physician's choice of CAPOX or FP
Drug: Cisplatin
Administered IV
Drug: Capecitabine
Administered orally (PO bid)
Drug: Oxaliplatin
Administered IV
Drug: 5-Fluorouracil
Administered IV
Drug: Zanidatamab
Administered IV
Other Names:
  • ZW25
  • JZP598
Experimental: Arm C
Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP
Drug: Cisplatin
Administered IV
Drug: Capecitabine
Administered orally (PO bid)
Drug: Oxaliplatin
Administered IV
Drug: 5-Fluorouracil
Administered IV
Drug: Zanidatamab
Administered IV
Other Names:
  • ZW25
  • JZP598
Drug: Tislelizumab
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) by blinded independent central review (BICR)
Time Frame: Up to 2.5 years
The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) as assessed by BICR or death from any cause
Up to 2.5 years
Overall survival
Time Frame: Up to 3.5 years
The time from randomization to death due to any cause
Up to 3.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed objective response rate (ORR) by BICR
Time Frame: Up to 2.5 years
Number of patients who achieved a best overall response of complete response (CR) or (PR) as determined per RECIST 1.1 as assessed by BICR
Up to 2.5 years
Duration of response (DOR) by BICR
Time Frame: Up to 2.5 years
The time from the first objective response (CR or PR) per BICR to documented progressive disease per RECIST 1.1 as assessed by BICR or death from any cause
Up to 2.5 years
PFS per Investigator assessment
Time Frame: Up to 2.5 years
The time from randomization to the date of documented disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause
Up to 2.5 years
DOR per Investigator assessment
Time Frame: Up to 2.5 years
The time from the first objective response (CR or PR) per Investigator to documented progressive disease per RECIST 1.1 as assessed by Investigator or death from any cause
Up to 2.5 years
Incidence of adverse events
Time Frame: Up to 2 years
Number of subjects who experienced adverse events or serious adverse events
Up to 2 years
Incidence of clinical laboratory abnormalities
Time Frame: Up to 2 years
Number of patients who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Up to 2 years
Health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (core cancer questionnaire) C30 (QLQ-C30)
Time Frame: Up to 2.5 years
Changes from baseline in the EORTC QLQ-C30 scores
Up to 2.5 years
HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25)
Time Frame: Up to 2.5 years
Changes from baseline in the EORTC QLQ-OG25 scores
Up to 2.5 years
HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire
Time Frame: Up to 2.5 years
Changes from baseline in the EORTC EQ-5D-5L questionnaire scores
Up to 2.5 years
Incidence of anti-drug antibodies (ADAs)
Time Frame: Up to 2 years
Number of patients who develop ADAs
Up to 2 years
Confirmed ORR per Investigator assessment
Time Frame: Up to 2.5 years
Number of patients who achieved a best overall response of CR or PR as determined per RECIST 1.1 as assessed by Investigator
Up to 2.5 years
Serum concentration of zanidatamab and tislelizumab
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Collaborators

BeiGene, Ltd.

Investigators

  • Study Director: Jonathan Grim, MD, PhD, Zymeworks Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZWI-ZW25-301
  • 2021-000296-36 (EudraCT Number)
  • jRCT2061230026 (Registry Identifier: Japan Registry for Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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