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RecruitingLast updated: 10 July 2026

SUNRAY-01: Does adding the targeted drug olomorasib to standard treatment improve outcomes for people with previously untreated advanced non-small cell lung cancer with KRAS G12C mutation?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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

SUNRAY-01

Clinical summary

Summary

The purpose of this study is to find out if adding the targeted drug olomorasib (also known as LY3537982) in combination with standard anti-cancer treatment works better than standard treatment alone for people with previously untreated advanced non-small cell lung cancer (NSCLC).

You may be eligible for this study if you have:

  • locally advanced or metastatic NSCLC
  • a gene change (mutation) called KRAS G12C
  • have not received drug treatment for your advanced cancer (treatment at an earlier stage may be allowed)

Participants in this trial will receive immunotherapy (pembrolizumab) with or without chemotherapy, which are standard treatments for this type of lung cancer. Some participants will also receive olomorasib, while others will receive a placebo (inactive tablet) for comparison.

The study is done in stages. Early parts help find the best dose and check the safety of the treatment combination. Later parts compare the new treatment combination with standard care to see which works better.

Treatment is given in cycles every 3 weeks. Participants may continue treatment for as long as it is helping their cancer and side effects are manageable.

 

Conditions

This trial is treating people with stage IIIB-IIIC or stage IV non-small cell lung cancer with KRAS G12C mutation

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06119581 *
  • 2023-503412-33-00 *
  • 18612, J3M-MC-JZQB, U1111-1288-0565

Trial sponsor

Eli Lilly and Company

Scientific Title

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

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