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

Esophageal Adenocarcinoma Clinical Trial

— HERIZON-GEA-01  

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)

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
• Start date: December 2, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2024
• Source: Jazz Pharmaceuticals
• Contact: Clinical Trial Disclosure & Transparency
• Phone: 215-832-3750
• Email: ClinicalTrialDisclosure[@]JazzPharma.com
• Is FDA regulated: No
• 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: 714
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Adenocarcinoma
• Gastric Neoplasms
• Gastroesophageal Adenocarcinoma
• Stomach Neoplasms

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	Fundação Pio XII Hospital de Câncer de Barretos	Barretos
Brazil	Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto	Barretos
Brazil	Cenantron - Centro Avancado de Tratamento Oncologico Ltda	Belo Horizonte
Brazil	Hospital Amaral Carvalho	Brasília
Brazil	Instituto Do Câncer Do Ceará ICC	Fortaleza
Brazil	Associação Hospital de Caridade Ijuí	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	Instituto Brasileiro de Controle Do Câncer IBCC	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	Research Site	Providencia
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 Hospital	Changzhi
China	The First People's Hospital of Changzhou	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 Cancer Hospital	Jinan
China	Shandong Cancer Hospital	Jinan
China	Yunnan Cancer Hospital	Kunming
China	Gansu Provincial 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	Institut Sainte Catherine	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	Research Site	Frankfurt am Main
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Research Site	Trier
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	Celan S.A.	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	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	Research Site 2	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
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	ICO l'Hospitalet - Hospital Duran i 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	Bangkok Metropolitan Administration Medical College and Vajira Hospital	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Siriraj Hospital Mahidol University	Bangkok Noi
Thailand	Prince of Songkla University	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	Research site	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	Municipal Non-profit Enterprise "Odessa Regional Oncology Dispensary" of Odesa RC	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 blinded independent central review (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 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	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