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Study of Olomorasib for KRAS G12C-mutant Non-Small Cell Lung Cancer

This study is looking at a new treatment for non-small cell lung cancer (NSCLC) that has a specific genetic change called a KRAS G12C mutation. You might be eligible if you are 18 or older and have NSCLC that has this mutation. The study is testing a drug called olomorasib in combination with either pembrolizumab or durvalumab. Researchers want to see if these combinations are more effective than pembrolizumab or durvalumab alone (with a placebo). The study will measure how long people live without their cancer returning (Disease-Free Survival) or getting worse (Progression-Free Survival). This study plans to enroll about 700 participants.

Study design
This interventional study is comparing different drug combinations in participants with KRAS G12C-mutant non-small cell lung cancer. It plans to enroll about 700 participants.
What's involved
Each participant may be in the study for up to 3 years. You will receive either olomorasib or placebo orally, and either pembrolizumab or durvalumab intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
For Part A, Disease-Free Survival will be measured for approximately 4 years. For Part B, Progression-Free Survival will be measured for approximately 3 years.

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

NCT06890598

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Eli Lilly and Company
~700 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:OlomorasibPembrolizumabDurvalumabPlacebo

At a glance

Recruiting sites
338 of 369 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Disease-Free Survival (DFS) by Investigator Assessment
Measured over Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).
+1 more outcome measured

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

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

Where it's being run

369 sites across 60 states
China41
Japan21
Germany20
South Korea20
Taiwan19
Spain18
Brazil16
France15

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

Histological or cytological confirmation of NSCLC.
Part A
Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
Must have disease with evidence of KRAS G12C mutation.
Must have known programmed death-ligand 1 (PD-L1) expression
Must have an ECOG performance status of 0 or 1.
Able to swallow oral medication.
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 known, actionable changes in the EGFR or ALK genes.
Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.

What this trial measures

  • Part A: Disease-Free Survival (DFS) by Investigator AssessmentRandomization to disease recurrence or death from any cause (Estimated as approximately 4 years).

    DFS by Investigator Assessment

  • Part B: Progression-Free Survival (PFS) by BICRRandomization to disease progression or death from any cause (Estimated as approximately 3 years).

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