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

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Arcus Biosciences, Inc.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Pembrolizumab; Pemetrexed

Criteria

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 known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other actionable driver oncogenes with approved therapies (actionable genomic alteration).

• Have not received prior systemic treatment for metastatic NSCLC.

• Measurable disease by CT or MRI as 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 (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).

• Are receiving chronic systemic steroids.

• Have significant third-space fluid retention

• Have known active 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.