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ACTIVE NOT RECRUITING
NCT05502237
PHASE3

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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 overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

Official title: A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1021

Start Date

2022-10-12

Completion Date

2029-01

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DRUG

Zimberelimab

Administered intravenously

DRUG

Domvanalimab

Administered intravenously

DRUG

Pembrolizumab

Administered intravenously

DRUG

Carboplatin

Administered intravenously

DRUG

Cisplatin

Administered intravenously

DRUG

Paclitaxel

Administered intravenously

DRUG

Nab-paclitaxel

Administered intravenously

DRUG

Pemetrexed

Administered intravenously

Locations (186)

Innovative Clinical Research Institute

Whittier, California, United States

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, United States

Moffitt Cancer Center

Tampa, Florida, United States

Illinois Cancer Care

Peoria, Illinois, United States

Messino Cancer Centers

Asheville, North Carolina, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States

Hematology & Oncology Associates

Eugene, Oregon, United States

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Texas Oncology - Austin

Austin, Texas, United States

Oncology and Hematology Associates of Southwest Virginia, Inc

Blacksburg, Virginia, United States

Northwest Cancer Specialists, PC

Vancouver, Washington, United States

Investigaciones CORI S.R.L.

Capital, Argentina

Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Cardoba, Argentina

Sanatorio Allende

Córdoba, Argentina

Sanatorio Britanico de Rosario

Rosario, Argentina

Sanatorio Parque de Rosario

Rosario, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

Clínica Viedma

Viedma, Argentina

Ordensklinikum Linz GmbH, Elisabethinen

Linz, Austria

Krankenhaus Nord - Klinik Floridsdorf

Vienna, Austria

Klinikum Wels-Grieskirchen

Wels, Austria

Algemeen Ziekenhuis Sint-Lucas

Aalst, Belgium

Grand Hopital de Charleroi asbl (GHdC)

Charleroi, Belgium

AZ Sint-Maarten

Mechelen, Belgium

CHU UCL Namur / Site Sainte Elisabeth

Namur, Belgium

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Brazil

Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Brazil

Fundacao Universidade De Caxias Do Sul - FUCS/RS

Caxias do Sul, Brazil

Instituto do Câncer do Ceará - ICC

Fortaleza, Brazil

Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA

Ijuí, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Brazil

Hospital Ana Nery Santa Cruz do Sul

Santa Cruz do Sul, Brazil

Instituto Brasiliero de Controle do Cancer IBCC

São Paulo, Brazil

Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

São Paulo, Brazil

Centre Integre de sante et de services sociaux de la Monteregie Centre

Greenfield Park, Canada

Moncton Hospital

Moncton, Canada

CISSS des Laurentides

Québec, Canada

Centre de santé et services sociaux de Rimouski-Neigette

Rimouski, Canada

Clinica Alemana de Santiago

Las Condes, Chile

Clinica Puerto Montt

Port Montt, Chile

Orlandioncologia

Providencia, Chile

Oncovida- Santiago

Providencia, Chile

Biocinetic

Santiago, Chile

James Lind Centro de Investigacion del Cancer

Temuco, Chile

Oncocentro APYS

Viña del Mar, Chile

West China Hospital Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Deyang People's Hospital

Deyang, China

Fujian Cancer Hospital

Fuzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Guangzhou First People's Hospital

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

The Second Affiliated Hospital of Nanchang University

Jiangxi, China

Shandong Cancer Hospital

Jinan, China

Jiangxi Chest Hospital

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

Guangxi Medical University Cancer Hospital

Nanning, China

Shanghai Chest Hospital

Shanghai, China

Shanghai East Hospital

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Cancer Hospital of Shantou University Medical College

Shantou, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Tongji Hospital Tongji Medical College of Hust

Wuhan, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, China

Henan Cancer Hospital

Zhengzhou, China

Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris

Boulogne-Billancourt, France

Clinique Victor Hugo, Centre de Cancerologie de la Sarthe

Le Mans, France

Hopital Nord

Marseille, France

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

Montpellier, France

Institut de cancerologie de l'ouest (ICO)

Saint-Herblain, France

Hopital d'Instruction des Armees (HIA) Begin

Saint-Mandé, France

Centre Hospitalier de Saint-Quentin

Saint-Quentin, France

Hôpital Foch

Suresnes, France

CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse

Toulon, France

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

Cologne, Germany

Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

Essen, Germany

LungenClinic Grosshansdorf

Großhansdorf, Germany

Krankenhaus Martha-Maria Halle Dölau

Halle, Germany

Asklepios Kliniken Hamburg

Hamburg, Germany

Katholisches Marienkrankenhaus gGmbH

Hamburg, Germany

Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie

Hemer, Germany

Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2

Karlsruhe, Germany

Universitatsklinikum Schleswig-Holstein

Lübeck, Germany

Johannes Wesling Klinikum Minden

Minden, Germany

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

Offenbach, Germany

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Prince of Wales Hospital

New Territories, Hong Kong

Shaare Zedek Medical Center

Jerusalem, Israel

Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri

Nahariya, Israel

Rabin Medical Center

Petah Tikva, Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Italy

Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Italy

Ospedale Policlinico San Martino

Genova, Italy

Ospedale San Raffaele

Milan, Italy

AORN Cardarelli

Naples, Italy

IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica

Pavia, Italy

Azienda Sanitaria Territoriale Pesaro e Urbino (AST)

Pesaro, Italy

Ospedale Guglielmo da Saliceto AUSL di Piacenza

Piacenza, Italy

Centro di Riferimento Oncologico

Pordenone, Italy

Regina Elena Institute for Cancer Research

Rome, Italy

National Cancer Center Hospital East

Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Ehime, Japan

Kyushu University Hospital

Fukuoka, Japan

Kurume University Hospital

Fukuoka, Japan

National Hospital Organization Himeji Medical Center

Hyōgo, Japan

Hyogo Cancer Center

Hyōgo, Japan

Kanazawa University Hospital

Ishikawa, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Sendai Kousei Hospital

Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Osaka, Japan

Kindai University Hospital

Osaka, Japan

National Hospital Organization Kinki Chuo Chest Medical Center

Osaka, Japan

Saitama Medical University

Saitama, Japan

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

México, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Mitras Centro, Mexico

Oaxaca Site Management Organization

Oaxaca City, Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Mexico

Clinical Medical Research SC.

Orizaba Centro, Mexico

Clinica Integral Internacional de Oncologia S de RL de CV

Puebla City, Mexico

FAICIC Clínical Research

Veracruz, Mexico

Amphia Ziekenhuis

Breda, Netherlands

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Ziekenhuis St Jansdal

Harderwijk, Netherlands

TweeSteden Ziekenhuis

Tilburg, Netherlands

Hospital Prof. Doutor Fernando Fonseca

Amadora, Portugal

Instituto Português de Oncologia de Lisboa Francisco Gentil

Lisbon, Portugal

Fundacao Champalimaud

Lisbon, Portugal

Hospital Beatriz Angelo. Hospital de Loures.

Lisbon, Portugal

Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

Lisbon, Portugal

Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA

Senhora da Hora, Portugal

Tang Tock Seng Hospital

Singapore, Singapore

Samsung Medical Center

Gangnam-Gu, South Korea

National Cancer Center

Goyang, South Korea

Chungbuk National University Hospital

Heungdeok-Gu, South Korea

Gachon University Gil Medical Center

Inchon, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

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

Seoul, South Korea

The Catholic University of Korea, Saint Vincent's Hospital

Suwon, South Korea

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain

Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)

Barcelona, Spain

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Parc Tauli

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Doctor Josep Trueta

Girona, Spain

Hospital Universitario de Jaen

Jaén, Spain

Hospital Universitario de Canarias

Las Palmas de Gran Canaria, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain

Hospital Sant Joan de Reus

Reus, Spain

Hospital Regional Universitario de Malaga

Rincón de la Victoria, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Instituto Valenciano De Oncologia (IVO)

Valencia, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Hospital Vithas Valencia 9 de Octubre

Valencia, Spain

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

E-DA Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, Taiwan

Chi Mei Hospital, Liouying

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation

Taoyuan, Taiwan

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Trakya University Faculty of Medicine

Edirne, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih, Turkey (Türkiye)

Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

Istanbul, Turkey (Türkiye)

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi

Kaakaekmece, Turkey (Türkiye)

Turgut Ozal Medical Faculty

Malatya, Turkey (Türkiye)

St Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom

The Christie NHS Foundation Trust, Department of Medical Oncology

Manchester, United Kingdom