Actively Recruiting
SUNRAY-01 Global Study Comparing First-Line LY3537982 and Pembrolizumab Versus Placebo and Pembrolizumab in Advanced KRAS G12C-Mutant NSCLC with PD-L1 50 or LY3537982 and Pembrolizumab, Pemetrexed, Platinum Versus Placebo with Pembrolizumab, Pemetrexed, Platinum
Led by Eli Lilly and Company · Updated on 2026-06-03
1264
Participants Needed
422
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of LY3537982 olomorasib to standard anti-cancer treatments in people with advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene mutation. The study aims to see if combining LY3537982 with pembrolizumab, with or without chemotherapy, is more effective than standard care. This phase 3 trial includes participants with untreated advanced NSCLC and can last up to three years, depending on individual progress. Participants may receive different combinations of treatments in 21-day cycles, including LY3537982 taken orally with pembrolizumab given intravenously, sometimes combined with chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin. Some groups receive placebo pills instead of LY3537982. The study has multiple parts including dose optimization, safety lead-in, and randomized treatment phases. Participants can continue treatment until specific discontinuation criteria are met. During the trial, participants will undergo regular assessments for side effects and disease progression through scans and clinical evaluations. Researchers will measure progression-free survival, overall survival, response rates, and physical function, as well as lung cancer symptoms using questionnaires. Safety monitoring and quality-of-life assessments will continue during treatment and follow-up periods. The study collects data for up to three years to evaluate the treatments impact.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with Stage IIIB-IIIC or Stage IV disease not suitable for curative surgery or radiation
- Tumor must have KRAS G12C mutation
- Known PD-L1 expression: Part A ≥50%, Part B 0%-100%, Part C <50%
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Estimated life expectancy of at least 12 weeks
- Able to swallow capsules
- Adequate laboratory values
- Women of childbearing potential must have a negative pregnancy test and not be breastfeeding
- Use contraception consistent with local regulations
You will not qualify if you...
- Presence of additional validated targetable oncogenic mutations such as EGFR, ALK, BRAF V600E, HER2, MET exon 14, ROS1, RET, or NTRK1/2/3
- Prior systemic therapy for advanced or metastatic NSCLC, except one cycle of standard care if urgently needed
- Known active central nervous system metastases or carcinomatous meningitis
- For participants receiving pemetrexed and platinum: predominantly squamous histology
- Inability to avoid NSAIDs around the time of pemetrexed administration in cases of mild to moderate renal insufficiency
- Unable or unwilling to take folic acid or vitamin B12 supplements if receiving pemetrexed
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here