OncoMatch/Clinical Trials/Olomorasib

Olomorasib (LY3537982) Clinical Trials

Olomorasib (LY3537982) is a next-generation, highly selective KRAS G12C covalent inhibitor developed by Eli Lilly that received FDA Breakthrough Therapy designation for first-line treatment of KRAS G12C–mutant NSCLC with PD-L1 expression ≥50% in combination with pembrolizumab. The pivotal SUNRAY-01 Phase 3 trial is evaluating olomorasib plus pembrolizumab with or without chemotherapy versus standard of care in first-line KRAS G12C–mutant advanced NSCLC across two cohorts (PD-L1 ≥50% and unselected by PD-L1). Additional trials investigate olomorasib in combination with immunotherapy for earlier-stage (Stage II/III) NSCLC and in other KRAS G12C–mutant tumor types. Eligibility requires confirmed KRAS G12C mutation via tissue or liquid biopsy; most trials enroll treatment-naive patients for first-line evaluation.