Home › Trials › NCT06119581

Combining Olomorasib and Pembrolizumab for Advanced KRAS G12C-Mutant 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

Phase 3 Interventional Eli Lilly and Company · NCT06119581

This study is testing if a new drug combined with Pembrolizumab can help people with advanced lung cancer that has a specific genetic mutation feel better and live longer compared to standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1264 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations422 sites (Huntsville, Alabama and 421 other locations)
Trial IDNCT06119581 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the drug LY3537982 in combination with Pembrolizumab, with or without chemotherapy, for patients with untreated advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation (KRAS G12C). Participants will be randomized into different treatment groups, and the study will assess the safety and efficacy of these combinations over a follow-up period of up to three years. The goal is to determine if this new combination therapy offers better outcomes compared to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults with untreated advanced non-small cell lung cancer that has a KRAS G12C mutation and meets specific health criteria.

Not a fit: Patients with non-KRAS G12C mutations or those with early-stage lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with advanced KRAS G12C-mutant lung cancer.

How similar studies have performed: Other studies have shown promising results with targeted therapies for KRAS mutations, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
* Must have disease with evidence of KRAS G12C mutation.
* Must have known programmed death-ligand 1 (PD-L1) expression

  * Part A: Greater than or equal to (≥)50 percent (%).
  * Part B: 0% to 100%.
  * Part C: \<50%.
* Must have measurable disease per RECIST v1.1.
* Must have an ECOG performance status of 0 or 1.
* Estimated life expectancy ≥12 weeks.
* Ability to swallow capsules.
* Must have adequate laboratory parameters.
* Contraceptive use should be consistent with local regulations for those participating in clinical studies.
* Women of childbearing potential must

  * Have a negative pregnancy test.
  * Not be breastfeeding during treatment

Exclusion Criteria:

* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3.
* Have had any of the following prior to randomization:

  \-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.

  \--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:
* Have known active central nervous system metastases and/or carcinomatous meningitis.

Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)

* Have predominantly squamous cell histology for NSCLC
* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed
* Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Where this trial is running

Huntsville, Alabama and 421 other locations

+372 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell LungNeoplasm MetastasisAdvanced Non-Small Cell Lung CancerKRAS G12 Lung CancerAdvanced Lung CancerMetastatic Lung CancerKRAS G12C inhibitorKRAS G12C Positive
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.