OncRef

Clinical Trial: 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

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:Eli Lilly and Company
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-10-07

Study Overview

Brief 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.

Official Title

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

Conditions

Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Intervention / Treatment

  • Drug: LY3537982
  • Drug: Pembrolizumab
  • Drug: Placebo
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: Pemetrexed

Other Study ID Numbers

  • 18612
  • J3M-MC-JZQB
  • U1111-1288-0565
  • 2023-503412-33-00
  • 2023

Start Date (Actual)

2023-12-21

Primary Completion Date (Estimated)

2027-11

Study Completion Date (Estimated)

2031-01

Enrollment (Estimated)

1264

Study Type

Interventional

Phase

Phase 3