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New immunotherapy combo aims to outperform standard lung cancer treatment

NCT ID NCT05502237

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new combination of two immunotherapy drugs (zimberelimab and domvanalimab) plus chemotherapy works better than the current standard treatment (pembrolizumab plus chemotherapy) for people with advanced non-small cell lung cancer that has not been treated before. About 1,021 participants will receive one of the two treatments. The main goal is to see which group lives longer overall.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,021 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • AORN Cardarelli

    Naples, 80131, Italy

  • AZ Sint-Maarten

    Mechelen, 2800, Belgium

  • Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi

    Kaakaekmece, 34303, Turkey (Türkiye)

  • Algemeen Ziekenhuis Sint-Lucas

    Aalst, 9300, Belgium

  • Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris

    Boulogne-Billancourt, 92100, France

  • Amphia Ziekenhuis

    Breda, 4818 CK, Netherlands

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06550, Turkey (Türkiye)

  • Asklepios Kliniken Hamburg

    Hamburg, 21075, Germany

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Italy

  • Azienda Sanitaria Territoriale Pesaro e Urbino (AST)

    Pesaro, 61122, Italy

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, 26100, Italy

  • Biocinetic

    Santiago, 8331143, Chile

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

    Toulon, 83056, France

  • CHU UCL Namur / Site Sainte Elisabeth

    Namur, 5000, Belgium

  • CISSS des Laurentides

    Québec, J7Z 2V4, Canada

  • Cancer Hospital of Shantou University Medical College

    Shantou, 0754-88555844, China

  • Cenantron Centro Avançado de Tratamento Oncologico Ltda

    Belo Horizonte, 30130-090, Brazil

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 2100, France

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

    Greenfield Park, J4V 2H1, Canada

  • Centre de santé et services sociaux de Rimouski-Neigette

    Rimouski, G5L5T1, Canada

  • Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

    São Paulo, 17210080, Brazil

  • Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

    Lisbon, Portugal

  • Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

    Cardoba, X5008HHW, Argentina

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020, Mexico

  • Centro di Riferimento Oncologico

    Pordenone, 33081, Italy

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 83301, Taiwan

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

    Taoyuan City, 33305, Taiwan

  • Changhua Christian Hospital

    Changhua, 500-06, Taiwan

  • Chi Mei Hospital, Liouying

    Tainan, 736, Taiwan

  • Chongqing University Cancer Hospital

    Chongqing, 400030, China

  • Chungbuk National University Hospital

    Heungdeok-Gu, 361-711, South Korea

  • Clinica Alemana de Santiago

    Las Condes, 7550000, Chile

  • Clinica Integral Internacional de Oncologia S de RL de CV

    Puebla City, 72530, Mexico

  • Clinica Puerto Montt

    Port Montt, 5500243, Chile

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Clinical Medical Research SC.

    Orizaba Centro, 94300, Mexico

  • Clinique Victor Hugo, Centre de Cancerologie de la Sarthe

    Le Mans, 72000, France

  • Clínica Viedma

    Viedma, 8500, Argentina

  • Deyang People's Hospital

    Deyang, 618000, China

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 6200, Turkey (Türkiye)

  • E-DA Hospital

    Kaohsiung City, 824, Taiwan

  • FAICIC Clínical Research

    Veracruz, 91900, Mexico

  • Fujian Cancer Hospital

    Fuzhou, 350014, China

  • Fundacao Champalimaud

    Lisbon, 1400-038, Portugal

  • Fundacao Universidade De Caxias Do Sul - FUCS/RS

    Caxias do Sul, 95070-560, Brazil

  • Gachon University Gil Medical Center

    Inchon, 21565, South Korea

  • George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20052, United States

  • Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

    Istanbul, 34093, Turkey (Türkiye)

  • Grand Hopital de Charleroi asbl (GHdC)

    Charleroi, 6000, Belgium

  • Guangxi Medical University Cancer Hospital

    Nanning, 530021, China

  • Guangzhou First People's Hospital

    Guangzhou, 510180, China

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

    México, 3100, Mexico

  • Hematology & Oncology Associates

    Eugene, Oregon, 97401, United States

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hopital Nord

    Marseille, 13005, France

  • Hopital d'Instruction des Armees (HIA) Begin

    Saint-Mandé, 94160, France

  • Hospital Ana Nery Santa Cruz do Sul

    Santa Cruz do Sul, 96810-110, Brazil

  • Hospital Beatriz Angelo. Hospital de Loures.

    Lisbon, 2674-514, Portugal

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Doctor Josep Trueta

    Girona, 17007, Spain

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, 29308-014, Brazil

  • Hospital Parc Tauli

    Barcelona, 8208, Spain

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora, 2720276, Portugal

  • Hospital Provincial del Centenario

    Rosario, S2002KDS, Argentina

  • Hospital Regional Universitario de Malaga

    Rincón de la Victoria, 29011, Spain

  • Hospital Sant Joan de Reus

    Reus, 43204, Spain

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610-000, Brazil

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

    Barcelona, 8028, Spain

  • Hospital Universitari Vall D'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46015, Spain

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Mitras Centro, 64460, Mexico

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28020, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41014, Spain

  • Hospital Universitario de Canarias

    Las Palmas de Gran Canaria, 35016, Spain

  • Hospital Universitario de Jaen

    Jaén, 23007, Spain

  • Hospital Vithas Valencia 9 de Octubre

    Valencia, 46015, Spain

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 08041, Spain

  • Hyogo Cancer Center

    Hyōgo, 673-8558, Japan

  • Hôpital Foch

    Suresnes, 92150, France

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

    Pavia, 27100, Italy

  • Illinois Cancer Care

    Peoria, Illinois, 61615, United States

  • Innovative Clinical Research Institute

    Whittier, California, 90606, United States

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

    Montpellier, 34928, France

  • Institut de cancerologie de l'ouest (ICO)

    Saint-Herblain, 44805, France

  • Instituto Brasiliero de Controle do Cancer IBCC

    São Paulo, 03102002, Brazil

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2013DTC, Argentina

  • Instituto Português de Oncologia de Lisboa Francisco Gentil

    Lisbon, 1089, Portugal

  • Instituto Valenciano De Oncologia (IVO)

    Valencia, 46009, Spain

  • Instituto do Câncer do Ceará - ICC

    Fortaleza, 60430-230, Brazil

  • Investigaciones CORI S.R.L.

    Capital, F5300COE, Argentina

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    Fatih, 34098, Turkey (Türkiye)

  • James Lind Centro de Investigacion del Cancer

    Temuco, 4800827, Chile

  • Jiangxi Chest Hospital

    Nanchang, 330006, China

  • Johannes Wesling Klinikum Minden

    Minden, 32429, Germany

  • Kanagawa Cancer Center

    Kanagawa, 241-0815, Japan

  • Kanazawa University Hospital

    Ishikawa, 920-8641, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Katholisches Marienkrankenhaus gGmbH

    Hamburg, 22087, Germany

  • Kindai University Hospital

    Osaka, 589-8511, Japan

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

    Cologne, 51109, Germany

  • Klinikum Wels-Grieskirchen

    Wels, 4600, Austria

  • Krankenhaus Martha-Maria Halle Dölau

    Halle, 06120, Germany

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, A-1140, Austria

  • Kurume University Hospital

    Fukuoka, 830-0011, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • LungenClinic Grosshansdorf

    Großhansdorf, 22927, Germany

  • Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie

    Hemer, 58675, Germany

  • Medipol Mega University Hospital

    Istanbul, Turkey (Türkiye)

  • Messino Cancer Centers

    Asheville, North Carolina, 28806, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Moncton Hospital

    Moncton, E1C 6Z8, Canada

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • National Cancer Center

    Goyang, 410769, South Korea

  • National Cancer Center Hospital East

    Chiba, 277-0882, Japan

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520, Japan

  • National Hospital Organization Kinki Chuo Chest Medical Center

    Osaka, 591-8555, Japan

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280, Japan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684, United States

  • Oaxaca Site Management Organization

    Oaxaca City, 68000, Mexico

  • Oncocentro APYS

    Viña del Mar, 2520612, Chile

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242, United States

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

    Nahariya, Israel

  • Oncology and Hematology Associates of Southwest Virginia, Inc

    Blacksburg, Virginia, 24060, United States

  • Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA

    Ijuí, 98700-000, Brazil

  • Oncovida- Santiago

    Providencia, 7510035, Chile

  • Ordensklinikum Linz GmbH, Elisabethinen

    Linz, 4020, Austria

  • Orlandioncologia

    Providencia, 7500006, Chile

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, 569-8686, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586, Japan

  • Ospedale Guglielmo da Saliceto AUSL di Piacenza

    Piacenza, 29100, Italy

  • Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Prince of Wales Hospital

    New Territories, Hong Kong

  • Queen Elizabeth Hospital

    Hong Kong, 999077, Hong Kong

  • Queen Mary Hospital

    Hong Kong, 999077, Hong Kong

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Regina Elena Institute for Cancer Research

    Rome, 00144, Italy

  • Saitama Medical University

    Saitama, 350-1298, Japan

  • Samsung Medical Center

    Gangnam-Gu, 6351, South Korea

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

    Offenbach, 63069, Germany

  • Sanatorio Allende

    Córdoba, 5000, Argentina

  • Sanatorio Britanico de Rosario

    Rosario, 2000, Argentina

  • Sanatorio Parque de Rosario

    Rosario, S2000DSV, Argentina

  • Sendai Kousei Hospital

    Miyagi, 981-0914, Japan

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shandong Cancer Hospital

    Jinan, 250021, China

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shanghai East Hospital

    Shanghai, 200120, China

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • St Bartholomew's Hospital, Barts Health NHS Trust

    London, EC1A 7BE, United Kingdom

  • Taipei Veterans General Hospital

    Taipei, 10002, Taiwan

  • Tang Tock Seng Hospital

    Singapore, 308433, Singapore

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Texas Oncology - Austin

    Austin, Texas, 78745, United States

  • The Catholic University of Korea, Saint Vincent's Hospital

    Suwon, 16247, South Korea

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

    Seoul, 06591, South Korea

  • The Christie NHS Foundation Trust, Department of Medical Oncology

    Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710049, China

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, 453100, China

  • The Second Affiliated Hospital of Nanchang University

    Jiangxi, 330006, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300181, China

  • Tongji Hospital Tongji Medical College of Hust

    Wuhan, 430030, China

  • Trakya University Faculty of Medicine

    Edirne, 22030, Turkey (Türkiye)

  • Turgut Ozal Medical Faculty

    Malatya, 44300, Turkey (Türkiye)

  • TweeSteden Ziekenhuis

    Tilburg, Netherlands

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

    Senhora da Hora, 4464-513, Portugal

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

    Essen, 45122, Germany

  • Universitatsklinikum Schleswig-Holstein

    Lübeck, 23538, Germany

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

    Karlsruhe, 76137, Germany

  • West China Hospital Sichuan University

    Chengdu, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310005, China

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP, Netherlands

  • Ziekenhuis St Jansdal

    Harderwijk, 3844 DG, Netherlands

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