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Clinical Trials in the UK / NCT05502237
Active, not recruiting Phase 3

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

NCT05502237 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2022-10-12
Last updated
2026-01-30

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

ZimberelimabDomvanalimabPembrolizumabCarboplatinCisplatinPaclitaxelNab-paclitaxelPemetrexed

Zimberelimab: Administered intravenously

Domvanalimab: Administered intravenously

Pembrolizumab: Administered intravenously

Carboplatin: Administered intravenously

Cisplatin: Administered intravenously

Paclitaxel: Administered intravenously

Nab-paclitaxel: Administered intravenously

Pemetrexed: Administered intravenously

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (186)

FacilityCityRegionStatus
Innovative Clinical Research Institute Whittier California
George Washington Medical Faculty Associates Washington D.C. District of Columbia
Moffitt Cancer Center Tampa Florida
Illinois Cancer Care Peoria Illinois
Messino Cancer Centers Asheville North Carolina
Oncology Hematology Care, Inc. Cincinnati Ohio
Hematology & Oncology Associates Eugene Oregon
AHN Allegheny General Hospital Pittsburgh Pennsylvania
Texas Oncology - Austin Austin Texas
Oncology and Hematology Associates of Southwest Virginia, Inc Blacksburg Virginia
Northwest Cancer Specialists, PC Vancouver Washington
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

+ 146 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05502237 on ClinicalTrials.gov ↗ ← All trials in the UK