NCT06119581

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,264 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

Detailed description

Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized. Part C is non-randomized.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	LY3537982	Administered orally.
DRUG	Pembrolizumab	Administered IV.
DRUG	Placebo	Administered orally.
DRUG	Cisplatin	Administered IV.
DRUG	Carboplatin	Administered IV.
DRUG	Pemetrexed	Administered IV.

Timeline

• Start date: 2023-12-21
• Primary completion: 2027-11-01
• Completion: 2031-01-01
• First posted: 2023-11-07
• Last updated: 2026-03-25

Locations

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

Regulatory

• FDA-regulated drug study