NCT06890598

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Olomorasib	Administered orally.
DRUG	Pembrolizumab	Administered intravenously (IV).
DRUG	Durvalumab	Administered IV.
DRUG	Placebo	Administered orally.

Timeline

• Start date: 2025-03-27
• Primary completion: 2029-05-01
• Completion: 2032-02-01
• First posted: 2025-03-24
• Last updated: 2026-03-24

Locations

354 sites across 29 countries: United States, Australia, Austria, Belgium, Brazil, Chile, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study