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

NCT06119581 · SUNRAY-01 Phase 3Recruiting

Lead sponsor
Eli Lilly and Company (Industry)
Enrollment
1,264 (estimated)
Start date
21 Dec 2023
Primary completion
Nov 2027 (estimated)
Study completion
1 Jan 2031
Last update posted
7 Oct 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
8

Interventions

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

Conditions and primary outcome

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

Primary outcome

Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) (Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)); Part A and Part B: Progression-Free Survival (PFS) (Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year))

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

1 on PubMed
  1. SUNRAY-01 trial protocol: an innovative study design of olomorasib and pembrolizumab with or without chemotherapy in KRAS G12C NSCLC.

    Future oncology (London, England) · 2026 Apr

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

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Data integrity

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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