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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05152147
Other study ID # ZWI-ZW25-301
Secondary ID 2021-000296-36jR
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 2, 2021
Est. completion date July 1, 2025

Study information

Verified date June 2024
Source Jazz Pharmaceuticals
Contact Clinical Trial Disclosure & Transparency
Phone 215-832-3750
Email ClinicalTrialDisclosure@JazzPharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 918
Est. completion date July 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
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

Country Name City State
Argentina Hospital de Gastroenterología Dr Bonorino Udaondo Buenos Aires
Argentina Hospital Italiano de Buenos Aires Buenos Aires
Argentina Instituto de Investigaciones Metabólicas - IDIM Ciudad Autónoma de Buenos Aires
Argentina Centro Médico Privado CEMAIC Córdoba
Argentina Fundación Centro de Medicina Nuclear y Molecular ER Córdoba
Argentina Centro de Investigación Pergamino S.A. Pergamino
Argentina Centro de Investigaciones Médicas Tucumán San Miguel De Tucumán
Argentina Centro de Investigación Clínica - Clínica Viedma Viedma
Australia Border Medical Oncology Research Unit Albury
Australia Flinders Medical Centre Bedford Park
Australia Austin Health Heidelberg
Australia Liverpool Hospital Liverpool
Australia Fiona Stanley Hospital Murdoch
Belgium Imelda VZW Bonheiden
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium UZ Gent Gent
Belgium UZ Leuven Leuven
Belgium CHU de Liège Liège
Brazil 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 ONCOSITE Centro de Pesquisa Clínica Em Oncologia Ijuí
Brazil Hospital de Clinicas de Porto Alegre (HCPA) - PPDS Porto Alegre
Brazil Hospital Nossa Senhora Da Conceição Porto Alegre
Brazil Hospital Sao Lucas da PUCRS Porto Alegre
Brazil Irmandade Da Santa Casa de Misericordia de Porto Alegre Porto Alegre
Brazil INCA - Instituto Nacional de Câncer José Alencar G Rio De Janeiro
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
Canada Princess Margaret Cancer Centre Toronto
Chile Corporacion de Beneficencia Osorno Osorno
Chile Centro de Estudios Clínicos SAGA SpA Providencia
Chile Fundación Arturo López Pérez (FALP) - PPDS Providencia Región-Metropolitana De Santiago
Chile Meditek Ltda Recoleta
Chile BIOCINETIC SpA Santiago
Chile Icegclinic Santiago
Chile Sociedad Oncovida S.A Santiago
Chile Sociedad de Investigaciones Medicas Limitada Temuco
China Beijing Cancer Hospital Beijing
China Beijing Chao-Yang Hospital, Capital Medical University Beijing
China Beijing Hospital Beijing
China Beijing Luhe Hospital, Capital Medical University Beijing
China Beijing Tiantan Hospital, Capital Medical University Beijing
China Cancer Hospital Chinese Academy of Medical Sciences Beijing
China Peking Union Medical College Hospital Beijing
China Peking University Third Hospital 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 Foshan First People's Hospital Foshan
China Fujian Cancer Hospital Fuzhou
China The First Affiliated Hospital of Fujian Medical University 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 Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou
China Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou
China The First Affiliated Hospital, College of Medicine, Zhejiang University 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 Jinan Central Hospital Jinan
China Shandong Cancer Hospital Jinan
China Yunnan Cancer Hospital Kunming
China Gansu Cancer Hospital Lanzhou
China The First Hospital of Lanzhou University 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 Fudan University Affiliated Zhongshan Hospital Shanghai
China Fudan University Shanghai Cancer Center Shanghai
China Research Site 1 Shanghai
China Research Site 2 Shanghai
China Ruijin hospital Shanghai Jiao Tong University School of Medicine Shanghai
China Shanghai 10th People's Hospital Shanghai
China Shanghai East Hospital Shanghai
China Shanghai General Hospital Shanghai
China Shangrao People's Hospital Shangrao
China Liaoning Cancer Hospital & Institute Shenyang
China The First Hospital of China Medical University Shenyang
China Peking University Shenzhen Hospital Shenzhen
China Research Site Shenzhen
China Shenzehen People's Hospital Shenzhen
China The Fourth Hospital of Hebei Medical University Shijiazhuang
China Tianjin Medical University Cancer Institute & Hospital Tianjin
China Tianjin Medical University General 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 Hubei Cancer Hospital Wuhan
China Union Hospital Tongji Medical College HuaZhong University of Science and Technology 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
Czechia Fakultni nemocnice Olomouc Hradec Králové
Estonia East Tallinn Central Hospital Tallinn
Estonia North Estonia Medical Centre Foundation Tallinn
France Sainte-Catherine, Institut du Cancer Avignon Provence Avignon
France Hopital Jean Minjoz Besançon
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
Georgia High Technology Hospital MedCenter Ltd Tbilisi
Georgia LTD TIM, Tbilisi Institute of Medicine Tbilisi
Georgia Research Institute of Clinical Medicine Tbilisi
Georgia Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies Tbilisi
Germany Institut für Klinisch-Onkologische Forschung Frankfurt am Main Hessen
Germany Medizinische Hochschule Hannover Hannover
Germany Universitaetsklinikum Leipzig Leipzig
Germany Klinikum Mutterhaus der Borromäerinnen Trier Rheinland-Pfalz
Germany Universitaetsklinikum Ulm Ulm
Greece Aretaieio Hospital of Athens Athens
Greece Attikon University General Hospital Athens
Greece Metaxa Memorial Cancer Hospital Piraeus Dept. ?f Medical Oncology Peiraias Attiki
Greece Research Site Piraeus
Greece Agios Loucas Clinic SA Thessaloniki
Greece Bioclinic Thessaloniki Oncology Department Thessaloniki
Greece Interbalkan Medical Center of Thessaloniki Oncology Department Thessaloniki
Guatemala Clinica Medica Especializada CELAN Guatemala City
Guatemala Grupo Medico Angeles Guatemala City
Guatemala Integra Cancer Institute Guatemala City
Guatemala Centro Medico Integral de Cancerologia CEMIC Salcaja
India The Bangalore Hospital Bangalore
India All India Institute of Medical Sciences, Bhubaneswar Bhubaneswar
India Artemis Hospital Gurgaon
India MNJ Institute of Oncology and Regional Cancer Centre Hyderabad
India Research Site Jaipur
India Curie Manavata Cancer Centre Nashik
India Indraprastha Apollo Hospitals New Delhi
India Regional Cancer Centre Indira Gandhi Institute of Medical Sciences Patna
India Deenanath Mangeshkar Hospital and Research Centre Pune
India HCG City Cancer Center Vijayawada
Ireland St James's Hospital Dublin
Italy 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 ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Milano
Italy Istituto Nazionale Dei Tumori Milano
Italy Ospedale San Raffaele S.r.l. - PPDS Milano
Italy Azienda Ospedaliero Universitaria Di Modena Policlinico Modena
Italy Arcispedale Santa Maria Nuova Reggio Emilia
Italy Fondazione Policlinico Universitario A Gemelli Rome
Italy Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino
Italy Centro Ricerche Cliniche Di Verona Verona
Italy Azienda ULSS 8 "Berica" - Ospedale San Bortolo Vicenza
Japan Hyogo Cancer Center Akashi-shi Hyôgo
Japan Chiba Cancer Center Chiba-Shi Tiba
Japan National Cancer Center Hospital Chuo Ku
Japan Kumamoto University Hospital - Honjo-Kuhonji Campus A Chuo-Ku Kumamoto
Japan Fukui Prefectural Hospital Fukui-shi Hukui
Japan National Hospital Organization Kyushu Cancer Center Fukuoka-shi
Japan Gifu University Hospital Gifu-Shi Gihu
Japan Kansai Medical University Hospital Hirakata Osaka
Japan Saitama Cancer Center Ina
Japan Ibaraki Prefectural Central Hospital Kasama-Shi Ibaraki
Japan National Cancer Center Hospital East Kashiwa-shi Tiba
Japan Kagawa University Hospital Kita-Gun Miki-Cho Kagawa
Japan Kobe City Medical Center General Hospital Kobe-Shi Chuo-Ku Hyôgo
Japan Kurashiki Central Hospital Kurashiki-Shi Okayama
Japan Shikoku Cancer Center Matsuyama
Japan Aichi Cancer Center Nagoya shi
Japan Niigata Cancer Center Hospital Niigata-shi
Japan Osaka International Cancer Institute Osaka
Japan Kindai University Hospital Osaka-sayama
Japan Osaki Citizen Hospital Osaki-Shi Miyagi
Japan Gunma Prefectural Cancer Center Ota-shi Gunma
Japan Kyoto University Hospital Sakyo-ku Kyoto-shi
Japan Keio University Hospital Shinjuku-Ku Tokyo
Japan Shizuoka Cancer Center Shizuoka
Japan Osaka University Hospital Suita-Shi Osaka
Japan Osaka Medical and Pharmaceutical University Hospital Takatsuki-Shi Osaka
Japan The Cancer Institute Hospital of Japanese Foundation For Cancer Research Tokyo
Japan Kanagawa Cancer Center Yokohama-Shi Asahi-Ku Kanagawa
Japan Kitasato University Hospital Yokohama-Shi Minami-Ku Kanagawa
Korea, Republic of Hallym University Sacred Heart Hospital Anyang-si
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of National Cancer Center Goyang-si
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam-si
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Health System - PPDS Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Malaysia Hospital Pulau Pinang George Town
Malaysia Pantai Hospital Kuala Lumpur Kuala Lumpur
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Sarawak General Hospital Kuching
Malaysia National Cancer Institute ( Institut Kanser Negara) Putrajaya
Mexico Clinstile, S.A. de C.V. Mexico City
Mexico Cryptex Investigación Clínica, S.A. de C.V. Mexico City
Mexico 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
Netherlands Catharina Hospital Eindhoven
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Leids Universitair Medisch Centrum Leiden
Netherlands ETZ-Elisabeth Tilburg
Poland Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lódz
Poland Centrum Medyczne Poznan - PRATIA - PPDS Skórzewo
Poland Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Warszawa
Portugal 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 Lisboa
Portugal Hospital Beatriz Angelo Loures
Portugal Unidade Local de Saúde de Matosinhos SA Matosinhos
Portugal Centro Hospitalar do Porto EPE Porto
Portugal Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS Porto
Romania Fundeni Clinical Institute Bucure?ti
Romania Cardiomed SRL Cluj-Napoca
Romania Medisprof SRL Cluj-Napoca
Romania Prof Dr I Chiricuta Institute of Oncology - PPDS Cluj-Napoca
Romania Onco Clinic Consult SA Craiova
Romania Oncology Center Sfantul Nectarie Craiova
Romania Institutul Regional de Oncologie Iasi Iasi
Serbia Clinical Hospital Center Bezanijska Kosa Belgrade
Serbia Institute for Oncology and Radiology of Serbia - PPDS Belgrade
Serbia Military Medical Academy Belgrade
Serbia University Clinical Center of Serbia - PPDS Belgrade
Serbia University Clinical Center Nis Niš
Serbia Oncology Institute of Vojvodina Sremska Kamenica
Singapore Curie Oncology Singapore
Singapore National Cancer Center Singapore Singapore
Singapore Oncocare Cancer Centre Singapore
South Africa Cape Town Oncology Trials Cape Town
South Africa Southern Cross Research South Africa (PTY) LTD Mogale City
South Africa University of Pretoria Pretoria
South Africa Wilgers Oncology Centre Pretoria
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 12 de Octubre Madrid
Spain Hospital Universitario La Paz - PPDS Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Regional Universitario de Malaga - Hospital General Málaga
Spain Complejo Hospitalario de Navarra Pamplona Navarra
Spain Corporacio Sanitaria Parc Tauli Sabadell Barcelona
Spain Complejo Asistencial Universitario de Salamanca - H. Clinico Salamanca
Spain Hospital Universitario Marques de Valdecilla Santander
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital Universitario Miguel Servet Zaragoza
Taiwan China Medical University Hospital Taichung
Taiwan Chi Mei Medical Center Tainan
Taiwan Mackay Memorial Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Thailand Phramongkutklao Hospital Bangkok
Thailand Vajira Hospital Bangkok
Thailand Siriraj Hospital Mahidol University Bangkok Noi
Thailand Songklanagarind Hospital Hat Yai
Thailand Srinagarind Hospital, Khon Kaen University Khon Kaen
Thailand Chulaborn Hospital Lak Si
Thailand Naresuan University Phitsanulok
Turkey Hacettepe Universitesi Kanser Enstitusu Ankara
Turkey Akdeniz University Medical Faculty Antalya
Turkey Antalya Yasam Onkoloji Merkezi Antalya
Turkey Research site Balçova
Turkey Uludag Universites Tip Fakultesi Hastanesi Bursa
Turkey Research site Çankaya
Turkey Research site Denizli
Turkey Dicle University Medical Faculty Diyarbakir
Turkey Trakya University Medical Faculty Edirne
Turkey Istanbul Universitesi Cerrahpasa Tip Fakultesi Fatih Istanbul
Turkey Research site Fatih
Turkey Dokuz Eylul Universitesi Izmir
Turkey Acibadem Maslak Hospital Sariyer
Turkey Acibadem Adana Hospital Seyhan
Turkey Research site Sur
Turkey Research site Tarabya
Turkey Medical Park Trabzon Yildizli Trabzon
Turkey Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital Yenimahalle
Ukraine Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS Dnipropetrovsk
Ukraine Communal Non-profit Enterprise Regional Center of Oncology Kharkiv
Ukraine MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council Kryvyi Rih
Ukraine Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center Kyiv
Ukraine Medical Center of Limited Liability Company "Medical center "VERUM EXPERT" Kyiv
Ukraine SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine Kyiv
Ukraine Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima Kyiv
Ukraine The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council Lutsk
Ukraine Daycare Facility of Dispensary-Polyclinic Department Odesa
United Kingdom 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 Mount Vernon Hospital Northwood
United Kingdom Edith Cavell Hospital Peterborough
United Kingdom Weston Park Cancer Centre Sheffield

Sponsors (2)

Lead Sponsor Collaborator
Jazz Pharmaceuticals BeiGene, Ltd.

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  Estonia,  France,  Georgia,  Germany,  Greece,  Guatemala,  India,  Ireland,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Serbia,  Singapore,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) by BICR 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 blinded independent central review (BICR) or death from any cause Up to 2.5 years
Primary Overall survival The time from randomization to death due to any cause Up to 3.5 years
Secondary Confirmed objective response rate (ORR) by BICR 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
Secondary Duration of response (DOR) by BICR 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
Secondary PFS per Investigator assessment 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
Secondary Confirmed ORR per Investigator assessment 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
Secondary DOR per Investigator assessment 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
Secondary Assessment of Contribution of Components based on Progression-free Survival (PFS) by BICR 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 blinded independent central review (BICR) or death from any cause Up to 2.5 years
Secondary Assessment of Contribution of Components based on Overall Survival The time from randomization to death due to any cause Up to 3.5 years
Secondary Incidence of adverse events Number of subjects who experienced adverse events or serious adverse events Up to 2 years
Secondary Incidence of clinical laboratory abnormalities 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
Secondary 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) Changes from baseline in the EORTC QLQ-C30 scores Up to 2.5 years
Secondary HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25) Changes from baseline in the EORTC QLQ-OG25 scores Up to 2.5 years
Secondary HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire Changes from baseline in the EORTC EQ-5D-5L questionnaire scores Up to 2.5 years
Secondary Serum concentration of zanidatamab and tislelizumab Up to 2 years
Secondary Incidence of anti-drug antibodies (ADAs) Number of patients who develop ADAs Up to 2 years
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