STATUS Recruitment Complete

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (STAR-121)

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-626-6216

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

January 30, 2026

Clinicaltrials.gov ID

NCT05502237

EudraCT ID

2022-000578-25

OVERVIEW

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 (STAR-121)

PROTOCOL 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.

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

Non-small Cell Lung Cancer

Gender

N/A

Date

October 2022 - June 2028

Study Type

Interventional

Study Phase

Phase 3

Product

Zimberelimab, Domvanalimab, Pembrolizumab, Carboplatin, Cisplatin, Paclitaxel, Nab-paclitaxel, Pemetrexed

Eligibility information

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.

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.

Locations

Locations (186)

Innovative Clinical Research Institute

Whittier, California, United States, 90606

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (STAR-121)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (186)

Innovative Clinical Research Institute

George Washington Medical Faculty Associates

Moffitt Cancer Center

Illinois Cancer Care

Messino Cancer Centers

Oncology Hematology Care, Inc.

Hematology & Oncology Associates

AHN Allegheny General Hospital

Texas Oncology - Austin

Oncology and Hematology Associates of Southwest Virginia, Inc

Northwest Cancer Specialists, PC

Investigaciones CORI S.R.L.

Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Sanatorio Allende

Sanatorio Britanico de Rosario

Sanatorio Parque de Rosario

Hospital Provincial del Centenario

Instituto Medico de la Fundacion Estudios Clinicos

Clínica Viedma

Ordensklinikum Linz GmbH, Elisabethinen

Krankenhaus Nord - Klinik Floridsdorf

Klinikum Wels-Grieskirchen

Algemeen Ziekenhuis Sint-Lucas

Grand Hopital de Charleroi asbl (GHdC)

AZ Sint-Maarten

CHU UCL Namur / Site Sainte Elisabeth

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Hospital Evangelico de Cachoeiro de Itapemirim

Fundacao Universidade De Caxias Do Sul - FUCS/RS

Instituto do Câncer do Ceará - ICC

Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA

Irmandade da Santa Casa de Misericordia de Porto Alegre

Hospital de Clínicas de Porto Alegre

Hospital São Lucas da PUCRS

Hospital Ana Nery Santa Cruz do Sul

Instituto Brasiliero de Controle do Cancer IBCC

Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

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

Moncton Hospital

CISSS des Laurentides

Centre de santé et services sociaux de Rimouski-Neigette

Clinica Alemana de Santiago

Clinica Puerto Montt

Orlandioncologia

Oncovida- Santiago

Biocinetic

James Lind Centro de Investigacion del Cancer

Oncocentro APYS

West China Hospital Sichuan University

Chongqing University Cancer Hospital

Deyang People's Hospital

Fujian Cancer Hospital

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou First People's Hospital

Zhejiang Cancer Hospital

The Second Affiliated Hospital of Nanchang University

Shandong Cancer Hospital

Jiangxi Chest Hospital

Nanjing Drum Tower Hospital

Guangxi Medical University Cancer Hospital

Shanghai Chest Hospital

Shanghai East Hospital

Shanghai Pulmonary Hospital

Cancer Hospital of Shantou University Medical College

Tianjin Medical University Cancer Institute & Hospital

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Tongji Hospital Tongji Medical College of Hust

The First Affiliated Hospital of Xian Jiaotong University