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
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
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.
Key Inclusion Criteria:
Life expectancy ≥ 3 months.
Pathologically documented NSCLC that meets both of the criteria below:
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:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Washington D.C., District of Columbia 20052, United States
Blacksburg, Virginia 24060, United States
Capital, F5300COE, Argentina
Cardoba, X5008HHW, Argentina
Greenfield Park, J4V 2H1, Canada
Wuhan, 430022, China
Essen, 45122, Germany
Karlsruhe, 76137, Germany
Offenbach, 63069, Germany
Ehime, 791-0280, Japan
Orizaba Centro, 94300, Mexico
Senhora da Hora, 4464-513, Portugal
Gangnam-Gu, 6351, South Korea
Heungdeok-Gu, 361-711, South Korea
Barcelona, 8028, Spain
Taoyuan City, 33305, Taiwan
Ankara, 6200, Turkey (Türkiye)
Kaakaekmece, 34303, Turkey (Türkiye)