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

Launched by GILEAD SCIENCES · Aug 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of treatments for patients with untreated metastatic non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread to other parts of the body. Researchers want to find out if using zimberelimab and domvanalimab along with chemotherapy is more effective than the standard treatment, which is pembrolizumab combined with chemotherapy, in helping patients live longer. The trial is currently active but not recruiting new participants.

To be eligible for this trial, participants should be adults aged 65 and older with a life expectancy of at least three months and a specific type of advanced lung cancer that has not been treated before. They should not have certain genetic mutations that would make them ineligible for this study. Participants can expect regular check-ups and assessments to monitor their health and the effectiveness of the treatment. It’s also important to note that individuals with certain health conditions or those who have received specific prior treatments may not qualify for this study.

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ALL

Eligibility 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 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.