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RecruitingPhase 3NCT06119581
Official study 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

Study summary

The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLY3537982 and Pembrolizumab

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 7, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 3

Interventional

Where is it offered?416 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: LY3537982; Drug: Pembrolizumab; Drug: Placebo; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
KRAS→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Clearview Cancer InstituteHuntsville, Alabama
  • Banner MD Anderson Cancer CenterGilbert, Arizona
  • Banner University Medical Center PhoenixPhoenix, Arizona
  • The University of Arizona Cancer Center - North CampusTucson, Arizona
  • Highlands Oncology GroupSpringdale, Arkansas
  • Cedars-Sinai Medical CenterLos Angeles, California
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, California
  • BASS Cancer CenterWalnut Creek, California
  • USO - Rocky Mountain Cancer CentersLone Tree, Colorado
  • Yale University School of MedicineNew Haven, Connecticut
  • Sibley Memorial HospitalWashington D.C., District of Columbia
  • Millennium Oncology Research ClinicHollywood, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 7, 2026. Always confirm current availability with the study team.

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