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Study of Olomorasib and Pembrolizumab for KRAS G12C-Mutant Lung Cancer

This study is for people with advanced non-small cell lung cancer (NSCLC) that has a specific change in a gene called KRAS G12C. Researchers are testing if adding the oral drug LY3537982 (olomorasib) to standard treatments like pembrolizumab (an immunotherapy given intravenously) and/or chemotherapy (cisplatin or carboplatin) is more effective than standard treatment alone. The study aims to see how safe these combinations are and how long people live without their cancer getting worse (progression-free survival). You may be eligible if you have advanced NSCLC with the KRAS G12C mutation and are at least 18 years old. The study plans to enroll 1264 participants.

Study design
This is an interventional study with some parts being randomized, meaning participants are assigned to different treatment groups by chance. Other parts are single-arm, where all participants receive the same treatment.
What's involved
Study participation, including follow-up, could last up to 3 years, depending on your health and your lung cancer's progress.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for approximately 1 year after randomization, or until disease progression or death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Eli Lilly and Company
~1,264 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:LY3537982PembrolizumabPlaceboCisplatinCarboplatinPemetrexed

At a glance

Recruiting sites
413 of 419 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Measured over Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
+1 more outcome measured

Conditions

Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis

Explore related trials

Lung Non-Small Cell CarcinomaGTPase KRasProgrammed Cell Death 1 Ligand 1

Where it's being run

419 sites across 65 states
China34
Japan30
Brazil29
Spain20
France18
Germany18
India18
Taiwan17

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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:
Have known active central nervous system metastases and/or carcinomatous meningitis.
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.

What this trial measures

  • 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)

    Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE

  • 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)

    PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)