NCT05502237

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,021 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-12
• Primary completion: 2028-06-01
• Completion: 2029-01-01
• First posted: 2022-08-16
• Last updated: 2026-01-30

Locations

186 sites across 23 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study