Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Trial Title: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

NCT ID: NCT05502237

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Zimberelimab
Description: Administered intravenously
Arm group label: Zimberelimab (ZIM) + Chemotherapy
Arm group label: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

Other name: GS-0122

Other name: AB122

Intervention type: Drug
Intervention name: Domvanalimab
Description: Administered intravenously
Arm group label: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

Other name: GS-0154

Other name: AB154

Intervention type: Drug
Intervention name: Pembrolizumab
Description: Administered intravenously
Arm group label: Pembrolizumab (PEMBRO) + Chemotherapy

Other name: KEYTRUDA®

Intervention type: Drug
Intervention name: Carboplatin
Description: Administered intravenously
Arm group label: Pembrolizumab (PEMBRO) + Chemotherapy
Arm group label: Zimberelimab (ZIM) + Chemotherapy
Arm group label: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

Intervention type: Drug
Intervention name: Cisplatin
Description: Administered intravenously
Arm group label: Pembrolizumab (PEMBRO) + Chemotherapy
Arm group label: Zimberelimab (ZIM) + Chemotherapy
Arm group label: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

Intervention type: Drug
Intervention name: Paclitaxel
Description: Administered intravenously
Arm group label: Pembrolizumab (PEMBRO) + Chemotherapy
Arm group label: Zimberelimab (ZIM) + Chemotherapy
Arm group label: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

Intervention type: Drug
Intervention name: Nab-paclitaxel
Description: Administered intravenously
Arm group label: Pembrolizumab (PEMBRO) + Chemotherapy
Arm group label: Zimberelimab (ZIM) + Chemotherapy
Arm group label: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

Intervention type: Drug
Intervention name: Pemetrexed
Description: Administered intravenously
Arm group label: Pembrolizumab (PEMBRO) + Chemotherapy
Arm group label: Zimberelimab (ZIM) + Chemotherapy
Arm group label: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

Summary: The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: - Life expectancy ≥ 3 months. - Pathologically documented NSCLC that meets both of the criteria below: - Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition). - Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations. - Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies. - Have not received prior systemic treatment for metastatic NSCLC. - Measurable disease per RECIST v1.1 criteria by investigator assessment. - Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. - Have adequate organ functions. Key Exclusion Criteria: - Have mixed small-cell lung cancer (SCLC) and NSCLC histology. - Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period. - Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint. - Known hypersensitivity to the study drug, its metabolites, or formulation excipient. - Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment. - Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). - Are receiving chronic systemic steroids. - Have significant third-space fluid retention. - Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. - Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment. - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. - Has had an allogenic tissue/solid organ transplant. - Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted. - Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: California Cancer Associates for Research and Excellence

Address:
City: San Marcos
Zip: 92069
Country: United States

Facility:
Name: Innovative Clinical Research Institute

Address:
City: Whittier
Zip: 90606
Country: United States

Facility:
Name: Eastern CT Hematology and Oncology Associates

Address:
City: Norwich
Zip: 06360
Country: United States

Facility:
Name: Lake City Cancer Care

Address:
City: Lake City
Zip: 32024
Country: United States

Facility:
Name: Florida Cancer Specialists

Address:
City: Sarasota
Zip: 34232
Country: United States

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Facility:
Name: Peachtree Hematology Oncology Consultants

Address:
City: Atlanta
Zip: 30318
Country: United States

Facility:
Name: Illinois Cancer Care

Address:
City: Peoria
Zip: 61615
Country: United States

Facility:
Name: Messino Cancer Centers

Address:
City: Asheville
Zip: 28806
Country: United States

Facility:
Name: Oncology Hematology Care, Inc.

Address:
City: Cincinnati
Zip: 45242
Country: United States

Facility:
Name: Hematology & Oncology Associates

Address:
City: Eugene
Zip: 97401
Country: United States

Facility:
Name: AHN Allegheny General Hospital

Address:
City: Pittsburgh
Zip: 15212
Country: United States

Facility:
Name: Texas Oncology - Austin

Address:
City: Austin
Zip: 78745
Country: United States

Facility:
Name: Texas Oncology

Address:
City: Dallas
Zip: 75246
Country: United States

Facility:
Name: Texas Oncology- Denison

Address:
City: Sherman
Zip: 75090
Country: United States

Facility:
Name: US Oncology Investigational Products Center (IPC)

Address:
City: Arlington
Zip: 22205
Country: United States

Facility:
Name: Oncology and Hematology Associates of Southwest Virginia, Inc

Address:
City: Blacksburg
Zip: 24060
Country: United States

Facility:
Name: Northwest Cancer Specialists, PC

Address:
City: Vancouver
Zip: 98684
Country: United States

Facility:
Name: Investigaciones CORI S.R.L.

Address:
City: Capital
Zip: F5300COE
Country: Argentina

Facility:
Name: Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Address:
City: Cardoba
Zip: X5008HHW
Country: Argentina

Facility:
Name: Centro Medico Barrio Parque

Address:
City: Ciudad Autanoma Buenos Aires
Zip: 1426
Country: Argentina

Facility:
Name: Sanatorio Allende

Address:
City: Cordoba
Zip: 5000
Country: Argentina

Facility:
Name: Sanatorio Britanico de Rosario

Address:
City: Rosario
Zip: 2000
Country: Argentina

Facility:
Name: Sanatorio Parque de Rosario

Address:
City: Rosario
Zip: S2000DSV
Country: Argentina

Facility:
Name: Hospital Provincial del Centenario

Address:
City: Rosario
Zip: S2002KDS
Country: Argentina

Facility:
Name: Instituto Medico de la Fundacion Estudios Clinicos

Address:
City: Rosario
Zip: S2013DTC
Country: Argentina

Facility:
Name: CAIPO - Centro para la Atención Integral del Paciente Oncológico

Address:
City: San Miguel de Tucumán
Zip: 4000
Country: Argentina

Facility:
Name: Clínica Viedma

Address:
City: Viedma
Zip: 8500
Country: Argentina

Facility:
Name: Klinikum Klagenfurt am Woerthersee

Address:
City: Klagenfurt Am Woerthersee
Country: Austria

Facility:
Name: Ordensklinikum Linz GmbH, Elisabethinen

Address:
City: Linz
Zip: 4020
Country: Austria

Facility:
Name: Klinikum Wels-Grieskirchen

Address:
City: Wels
Zip: 4600
Country: Austria

Facility:
Name: Krankenhaus Nord - Klinik Floridsdorf

Address:
City: Wien
Zip: A-1140
Country: Austria

Facility:
Name: Algemeen Ziekenhuis Sint-Lucas

Address:
City: Aalst
Zip: 9300
Country: Belgium

Facility:
Name: Grand Hopital de Charleroi asbl (GHdC)

Address:
City: Charleroi
Zip: 6000
Country: Belgium

Facility:
Name: AZ Sint-Maarten

Address:
City: Mechelen
Zip: 2800
Country: Belgium

Facility:
Name: CHU UCL Namur / Site Sainte Elisabeth

Address:
City: Namur
Zip: 5000
Country: Belgium

Facility:
Name: Cenantron Centro Avançado de Tratamento Oncologico Ltda

Address:
City: Belo Horizonte
Zip: 30130-090
Country: Brazil

Facility:
Name: Hospital Evangelico de Cachoeiro de Itapemirim

Address:
City: Cachoeiro De Itapemirim
Zip: 29308-014
Country: Brazil

Facility:
Name: Fundacao Universidade De Caxias Do Sul - FUCS/RS

Address:
City: Caxias Do Sul
Zip: 95070-560
Country: Brazil

Facility:
Name: Instituto do Câncer do Ceará - ICC

Address:
City: Fortaleza
Zip: 60430-230
Country: Brazil

Facility:
Name: Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA

Address:
City: Ijui
Zip: 98700-000
Country: Brazil

Facility:
Name: Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

Address:
City: Jau
Zip: 17210080
Country: Brazil

Facility:
Name: Irmandade da Santa Casa de Misericordia de Porto Alegre

Address:
City: Porto Alegre
Zip: 90020-090
Country: Brazil

Facility:
Name: Hospital de Clínicas de Porto Alegre

Address:
City: Porto Alegre
Zip: 90035-903
Country: Brazil

Facility:
Name: Hospital São Lucas da PUCRS

Address:
City: Porto Alegre
Zip: 90610-000
Country: Brazil

Facility:
Name: Hospital Ana Nery Santa Cruz do Sul

Address:
City: Santa Cruz Do Sul
Zip: 96810-110
Country: Brazil

Facility:
Name: Instituto Brasiliero de Controle do Cancer IBCC

Address:
City: Sao Paulo
Zip: 03102002
Country: Brazil

Facility:
Name: Centre Integre de sante et de services sociaux de la Monteregie Centre

Address:
City: Greenfield Park
Zip: J4V 2H1
Country: Canada

Facility:
Name: Moncton Hospital

Address:
City: Moncton
Zip: E1C 6Z8
Country: Canada

Facility:
Name: CISSS des Laurentides

Address:
City: Quebec
Zip: J7Z 2V4
Country: Canada

Facility:
Name: Centre de santé et services sociaux de Rimouski-Neigette

Address:
City: Rimouski
Zip: G5L5T1
Country: Canada

Facility:
Name: Clinica Alemana de Santiago

Address:
City: Las Condes
Zip: 7550000
Country: Chile

Facility:
Name: Orlandioncologia

Address:
City: Providencia
Zip: 7500006
Country: Chile

Facility:
Name: Oncovida- Santiago

Address:
City: Providencia
Zip: 7510035
Country: Chile

Facility:
Name: Clinica Puerto Montt

Address:
City: Puerto Montt
Zip: 5500243
Country: Chile

Facility:
Name: Biocinetic

Address:
City: Santiago
Zip: 8331143
Country: Chile

Facility:
Name: James Lind Centro de Investigacion del Cancer

Address:
City: Temuco
Zip: 4800827
Country: Chile

Facility:
Name: Oncocentro APYS

Address:
City: Vina del Mar
Zip: 2520612
Country: Chile

Facility:
Name: West China Hospital Sichuan University

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: Chongqing University Cancer Hospital

Address:
City: Chongqing
Zip: 400030
Country: China

Facility:
Name: Deyang People's Hospital

Address:
City: Deyang
Zip: 618000
Country: China

Facility:
Name: Fujian Cancer Hospital

Address:
City: Fuzhou
Zip: 350014
Country: China

Facility:
Name: The First Affiliated Hospital of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510120
Country: China

Facility:
Name: Guangzhou First People's Hospital

Address:
City: Guangzhou
Zip: 510180
Country: China

Facility:
Name: Nanfang Hospital, Southern Medical University

Address:
City: Guangzhou
Zip: 510515
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Zip: 310005
Country: China

Facility:
Name: Anhui Chest Hospital

Address:
City: Hefei
Zip: 230022
Country: China

Facility:
Name: The Second Affiliated Hospital of Nanchang University

Address:
City: Jiangxi
Zip: 330006
Country: China

Facility:
Name: Shandong Cancer Hospital

Address:
City: Jinan
Zip: 250021
Country: China

Facility:
Name: Jiangxi Chest Hospital

Address:
City: Nanchang
Zip: 330006
Country: China

Facility:
Name: Nanjing Drum Tower Hospital

Address:
City: Nanjing
Zip: 210008
Country: China

Facility:
Name: Guangxi Medical University Cancer Hospital

Address:
City: Nanning
Zip: 530021
Country: China

Facility:
Name: Shanghai Chest Hospital

Address:
City: Shanghai
Zip: 200030
Country: China

Facility:
Name: Shanghai Pulmonary Hospital

Address:
City: Shanghai
Zip: 200433
Country: China

Facility:
Name: Cancer Hospital of Shantou University Medical College

Address:
City: Shantou
Zip: 0754-88555844
Country: China

Facility:
Name: Tianjin Medical University Cancer Institute & Hospital

Address:
City: Tianjin
Zip: 300181
Country: China

Facility:
Name: Union Hospital Tongji Medical College Huazhong University of Science and Technology

Address:
City: Wuhan
Zip: 430022
Country: China

Facility:
Name: Tongji Hospital Tongji Medical College of Hust

Address:
City: Wuhan
Zip: 430030
Country: China

Facility:
Name: The First Affiliated Hospital of Xian Jiaotong University

Address:
City: Xi'an
Zip: 710049
Country: China

Facility:
Name: The First Affiliated Hospital of Xinxiang Medical College

Address:
City: Xinxiang
Zip: 453100
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris

Address:
City: Boulogne-Billancourt
Zip: 92100
Country: France

Facility:
Name: CHU de Caen

Address:
City: Caen
Zip: 14000
Country: France

Facility:
Name: Clinique Victor Hugo, Centre de Cancerologie de la Sarthe

Address:
City: Le Mans
Zip: 72000
Country: France

Facility:
Name: Hopital Nord

Address:
City: Marseille
Zip: 13005
Country: France

Facility:
Name: Institut de Cancer de Montpellier (ICM) - Val d'Aurelle

Address:
City: Montpellier
Zip: 34928
Country: France

Facility:
Name: Centre Antoine Lacassagne

Address:
City: Nice
Zip: 6189
Country: France

Facility:
Name: Institut de cancerologie de l'ouest (ICO)

Address:
City: Saint-Herblain
Zip: 44805
Country: France

Facility:
Name: Hopital d'Instruction des Armees (HIA) Begin

Address:
City: Saint-Mandé
Zip: 94160
Country: France

Facility:
Name: Centre Hospitalier de Saint-Quentin

Address:
City: Saint-Quentin
Zip: 2100
Country: France

Facility:
Name: Institut de Cancerologie Strasbourg Europe (ICANS)

Address:
City: Strasbourg
Zip: 67033
Country: France

Facility:
Name: Hôpital Foch

Address:
City: Suresnes
Zip: 92150
Country: France

Facility:
Name: CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse

Address:
City: Toulon cedex
Zip: 83056
Country: France

Facility:
Name: Augusta-Kranken-Anstalt gGmbh Klinik für Hämatologie Onkologie und Palliativmedizin

Address:
City: Bochum
Zip: 44791
Country: Germany

Facility:
Name: Klinikum Chemnitz gGmbH

Address:
City: Chemnitz
Zip: 9116
Country: Germany

Facility:
Name: Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

Address:
City: Essen
Zip: 45122
Country: Germany

Facility:
Name: Universitätsklinikum Freiburg, Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation

Address:
City: Freiburg
Zip: 79106
Country: Germany

Facility:
Name: LungenClinic Grosshansdorf

Address:
City: Grosshansdorf
Zip: 22927
Country: Germany

Facility:
Name: Krankenhaus Martha-Maria Halle Dölau

Address:
City: Halle
Zip: 06120
Country: Germany

Facility:
Name: Asklepios Kliniken Hamburg

Address:
City: Hamburg
Zip: 21075
Country: Germany

Facility:
Name: Katholisches Marienkrankenhaus gGmbH

Address:
City: Hamburg
Zip: 22087
Country: Germany

Facility:
Name: Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie

Address:
City: Hemer
Zip: 58675
Country: Germany

Facility:
Name: Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2

Address:
City: Karlsruhe
Zip: 76137
Country: Germany

Facility:
Name: Klinikum Kassel

Address:
City: Kassel
Zip: 34125
Country: Germany

Facility:
Name: Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik

Address:
City: Köln
Zip: 51109
Country: Germany

Facility:
Name: Universitatsklinikum Schleswig-Holstein

Address:
City: Lubeck
Zip: 23538
Country: Germany

Facility:
Name: Johannes Wesling Klinikum Minden

Address:
City: Minden
Zip: 32429
Country: Germany

Facility:
Name: Munchen Klinik Bogenhausen, Klinik fur Pneumologie und Pneumologische Onkologie

Address:
City: Munchen
Zip: 81925
Country: Germany

Facility:
Name: Sana Klinikum Offenbach GmbH, Medizinische Klinik IV, Hämatologie und Internistische Onkologie

Address:
City: Offenbach
Zip: 63069
Country: Germany

Facility:
Name: Queen Elizabeth Hospital

Address:
City: Hong Kong
Zip: 999077
Country: Hong Kong

Facility:
Name: Queen Mary Hospital

Address:
City: Hong Kong
Country: Hong Kong

Facility:
Name: Prince of Wales Hospital

Address:
City: New Territories
Country: Hong Kong

Facility:
Name: Soroka University Medical Center, Itzchak Rager Blvd.

Address:
City: Beer Seva
Zip: 84101
Country: Israel

Facility:
Name: Shaare Zedek Medical Center

Address:
City: Jerusalem
Zip: 9103102
Country: Israel

Facility:
Name: Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri

Address:
City: Nahariya
Country: Israel

Facility:
Name: Rabin Medical Center

Address:
City: Petah Tiqva
Zip: 49100
Country: Israel

Facility:
Name: Kaplan Medical Center

Address:
City: Rehovot
Zip: 76100
Country: Israel

Facility:
Name: Tel-Aviv Sourasky Medical Center

Address:
City: Tel Aviv
Zip: 64239
Country: Israel

Facility:
Name: Azienda Ospedaliera San Giuseppe Moscati

Address:
City: Avellino
Country: Italy

Facility:
Name: IRCCS Fondazoine del Piemonte per l'Oncologia

Address:
City: Candiolo
Zip: 10060
Country: Italy

Facility:
Name: Azienda Socio Sanitaria Territoriale di Cremona

Address:
City: Cremona
Zip: 26100
Country: Italy

Facility:
Name: Ospedale Policlinico San Martino

Address:
City: Genova
Zip: 16132
Country: Italy

Facility:
Name: Ospedale San Raffaele

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria di Modena

Address:
City: Modena
Zip: 41124
Country: Italy

Facility:
Name: AORN Cardarelli

Address:
City: Naples
Zip: 80131
Country: Italy

Facility:
Name: Azienda Ospedaliera dei Colli

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica

Address:
City: Pavia
Zip: 27100
Country: Italy

Facility:
Name: Azienda Sanitaria Territoriale Pesaro e Urbino (AST)

Address:
City: Pesaro
Zip: 61122
Country: Italy

Facility:
Name: Ospedale Guglielmo da Saliceto AUSL di Piacenza

Address:
City: Piacenza
Zip: 29100
Country: Italy

Facility:
Name: Centro di Riferimento Oncologico

Address:
City: Pordenone
Zip: 33081
Country: Italy

Facility:
Name: Regina Elena Institute for Cancer Research

Address:
City: Rome
Zip: 00144
Country: Italy

Facility:
Name: ASST Bergamo Ovest- ospedale di Treviglio

Address:
City: Treviglio
Zip: 24047
Country: Italy

Facility:
Name: National Cancer Center Hospital East

Address:
City: Chiba
Zip: 277-0882
Country: Japan

Facility:
Name: National Hospital Organization Shikoku Cancer Center

Address:
City: Ehime
Zip: 791-0280
Country: Japan

Facility:
Name: Kyushu University Hospital

Address:
City: Fukuoka
Zip: 812-8582
Country: Japan

Facility:
Name: Kurume University Hospital

Address:
City: Fukuoka
Zip: 830-0011
Country: Japan

Facility:
Name: National Hospital Organization Himeji Medical Center

Address:
City: Hyogo
Zip: 670-8520
Country: Japan

Facility:
Name: Hyogo Cancer Center

Address:
City: Hyogo
Zip: 673-8558
Country: Japan

Facility:
Name: Kanazawa University Hospital

Address:
City: Ishikawa
Zip: 920-8641
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Kanagawa
Zip: 241-0815
Country: Japan

Facility:
Name: Sendai Kousei Hospital

Address:
City: Miyagi
Zip: 981-0914
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital

Address:
City: Niigata
Zip: 951-8566
Country: Japan

Facility:
Name: Osaka Metropolitan University Hospital

Address:
City: Osaka
Zip: 545-8586
Country: Japan

Facility:
Name: Osaka Medical and Pharmaceutical University Hospital

Address:
City: Osaka
Zip: 569-8686
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Osaka
Zip: 589-8511
Country: Japan

Facility:
Name: National Hospital Organization Kinki Chuo Chest Medical Center

Address:
City: Osaka
Zip: 591-8555
Country: Japan

Facility:
Name: Saitama Medical University

Address:
City: Saitama
Zip: 350-1298
Country: Japan

Facility:
Name: SMG - SNU Boramae Medical Center

Address:
City: Dongjak-Gu
Zip: 07061
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Gangnam-Gu
Zip: 6351
Country: Korea, Republic of

Facility:
Name: National Cancer Center

Address:
City: Goyang
Zip: 410769
Country: Korea, Republic of

Facility:
Name: Chungbuk National University Hospital

Address:
City: Heungdeok-Gu
Zip: 361-711
Country: Korea, Republic of

Facility:
Name: Inha University Hospital

Address:
City: Incheon
Zip: 22332
Country: Korea, Republic of

Facility:
Name: Gachon University Gil Medical Center

Address:
City: Inchon
Zip: 21565
Country: Korea, Republic of

Facility:
Name: Kosin University Gospel Hospital

Address:
City: Seo-gu
Zip: 49267
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

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

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Ajou University Hospital

Address:
City: Suwon-si
Zip: 16499
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea, Saint Vincent's Hospital

Address:
City: Suwon
Zip: 16247
Country: Korea, Republic of

Facility:
Name: Health Pharma Professional Research S.A. de C.V.

Address:
City: Mexico
Zip: 3100
Country: Mexico

Facility:
Name: Hospital Universitario Dr. Jose Eleuterio Gonzalez

Address:
City: Mitras Centro
Zip: 64460
Country: Mexico

Facility:
Name: Oaxaca Site Management Organization

Address:
City: Oaxaca
Zip: 68000
Country: Mexico

Facility:
Name: Centro de Investigacion Clinica de Oaxaca

Address:
City: Oaxaca
Zip: 68020
Country: Mexico

Facility:
Name: Clinical Medical Research SC.

Address:
City: Orizaba Centro
Zip: 94300
Country: Mexico

Facility:
Name: Clinica Integral Internacional de Oncologia S de RL de CV

Address:
City: Puebla
Zip: 72530
Country: Mexico

Facility:
Name: FAICIC Clínical Research

Address:
City: Veracruz
Zip: 91900
Country: Mexico

Facility:
Name: Amphia Ziekenhuis

Address:
City: Breda
Zip: 4818 CK
Country: Netherlands

Facility:
Name: Ziekenhuis Gelderse Vallei

Address:
City: Ede
Zip: 6716 RP
Country: Netherlands

Facility:
Name: Universitair Medisch Centrum Groningen

Address:
City: Groningen
Zip: 9713 GZ
Country: Netherlands

Facility:
Name: Ziekenhuis St Jansdal

Address:
City: Harderwijk
Zip: 3844 DG
Country: Netherlands

Facility:
Name: TweeSteden Ziekenhuis

Address:
City: Tilburg
Country: Netherlands

Facility:
Name: Hospital Prof. Doutor Fernando Fonseca

Address:
City: Amadora
Zip: 2720276
Country: Portugal

Facility:
Name: Instituto Português de Oncologia de Lisboa Francisco Gentil

Address:
City: Lisboa
Zip: 1089
Country: Portugal

Facility:
Name: Fundacao Champalimaud

Address:
City: Lisboa
Zip: 1400-038
Country: Portugal

Facility:
Name: Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

Address:
City: Lisboa
Country: Portugal

Facility:
Name: Hospital Beatriz Angelo. Hospital de Loures.

Address:
City: Lisbon
Zip: 2674-514
Country: Portugal

Facility:
Name: Centro Hospitalar Universitario Sao Joao, EPE

Address:
City: Porto
Zip: 4202-451
Country: Portugal

Facility:
Name: Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA

Address:
City: Senhora da Hora
Zip: 4464-513
Country: Portugal

Facility:
Name: Raffles Hospital

Address:
City: Singapore
Zip: 188770
Country: Singapore

Facility:
Name: Tang Tock Seng Hospital

Address:
City: Singapore
Zip: 308433
Country: Singapore

Facility:
Name: Hospital Clinic de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Hospital de la Santa Creu i de Sant Pau

Address:
City: Barcelona
Zip: 08041
Country: Spain

Facility:
Name: Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)

Address:
City: Barcelona
Zip: 8028
Country: Spain

Facility:
Name: Hospital Universitari Vall D'Hebron

Address:
City: Barcelona
Zip: 8035
Country: Spain

Facility:
Name: Hospital Parc Tauli

Address:
City: Barcelona
Zip: 8208
Country: Spain

Facility:
Name: Hospital Universitario Reina Sofia

Address:
City: Cordoba
Zip: 14004
Country: Spain

Facility:
Name: Hospital Doctor Josep Trueta

Address:
City: Girona
Zip: 17007
Country: Spain

Facility:
Name: Hospital Universitario de Jaen

Address:
City: Jaen
Zip: 23007
Country: Spain

Facility:
Name: Hospital Universitario de Canarias

Address:
City: Las Palmas de G.C.
Zip: 35016
Country: Spain

Facility:
Name: Hospital Universitario Fundacion Jimenez Diaz

Address:
City: Madrid
Zip: 28020
Country: Spain

Facility:
Name: Clinica Universidad de Navarra

Address:
City: Madrid
Zip: 28027
Country: Spain

Facility:
Name: Hospital Universitario La Paz

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Hospital Universitario Puerta de Hierro de Majadahonda

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Facility:
Name: Hospital Sant Joan de Reus

Address:
City: Reus
Zip: 43204
Country: Spain

Facility:
Name: Hospital Regional Universitario de Malaga

Address:
City: Rincon de la Victoria
Zip: 29011
Country: Spain

Facility:
Name: Hospital Universitario Virgen Macarena

Address:
City: Sevilla
Zip: 41009
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio

Address:
City: Seville
Zip: 41014
Country: Spain

Facility:
Name: Instituto Valenciano De Oncologia (IVO)

Address:
City: Valencia
Zip: 46009
Country: Spain

Facility:
Name: Hospital Universitari i Politecnic La Fe

Address:
City: Valencia
Zip: 46015
Country: Spain

Facility:
Name: Hospital Vithas Valencia 9 de Octubre

Address:
City: Valencia
Zip: 46015
Country: Spain

Facility:
Name: Changhua Christian Hospital

Address:
City: Changhua City
Zip: 500-06
Country: Taiwan

Facility:
Name: E-DA Hospital

Address:
City: Kaohsiung City
Zip: 824
Country: Taiwan

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: Chang Gung Memorial Hospital Kaohsiung

Address:
City: Kaohsiung
Zip: 83301
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 70403
Country: Taiwan

Facility:
Name: Chi Mei Hospital, Liouying

Address:
City: Tainan
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei City
Zip: 100
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Facility:
Name: Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation

Address:
City: Taoyuan City
Zip: 33305
Country: Taiwan

Facility:
Name: Ankara Bilkent Sehir Hastanesi

Address:
City: Ankara
Zip: 06550
Country: Turkey

Facility:
Name: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Address:
City: Ankara
Zip: 6200
Country: Turkey

Facility:
Name: Trakya University Faculty of Medicine

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: Istanbul University Cerrahpasa Medical Faculty Hospital

Address:
City: Fatih
Zip: 34098
Country: Turkey

Facility:
Name: Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

Address:
City: Istanbul
Zip: 34093
Country: Turkey

Facility:
Name: Medipol Mega University Hospital

Address:
City: Istanbul
Country: Turkey

Facility:
Name: Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi

Address:
City: Kaakaekmece
Zip: 34303
Country: Turkey

Facility:
Name: Turgut Ozal Medical Faculty

Address:
City: Malatya
Zip: 44300
Country: Turkey

Facility:
Name: Colchester General Hospital

Address:
City: Colchester
Zip: CO4 5JL
Country: United Kingdom

Facility:
Name: St Bartholomew's Hospital, Barts Health NHS Trust

Address:
City: London
Zip: EC1A 7BE
Country: United Kingdom

Facility:
Name: The Christie NHS Foundation Trust, Department of Medical Oncology

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Facility:
Name: University Hospital Southampton Nhs Foundation Trust

Address:
City: Southampton
Zip: SO16 6YD
Country: United Kingdom

Start date: October 12, 2022

Completion date: September 2027

Lead sponsor:
Agency: Gilead Sciences
Agency class: Industry

Collaborator:
Agency: Arcus Biosciences, Inc.
Agency class: Industry

Source: Gilead Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05502237
https://www.gileadclinicaltrials.com/study/?id=GS-US-626-6216