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OncoMatch/Clinical Trials/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

Is NCT06119581 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for carcinoma, non-small-cell lung.

Phase 3RecruitingEli Lilly and CompanyNCT06119581Data as of Jun 2026Location: International · 29 countries

Treatment: LY3537982 · Pembrolizumab · Cisplatin · Carboplatin · PemetrexedThe 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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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Chemotherapy

CisplatinCarboplatinPemetrexed

Other

LY3537982

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: KRAS G12C

Must have disease with evidence of KRAS G12C mutation

Excluded: EGFR actionable genomic alteration

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

Excluded: ALK actionable genomic alteration

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

Excluded: BRAF V600E

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

Excluded: HER2 (ERBB2) actionable genomic alteration

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

Excluded: MET exon 14

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

Excluded: ROS1 actionable genomic alteration

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

Excluded: RET actionable genomic alteration

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

Excluded: NTRK1 actionable genomic alteration

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

Excluded: NTRK2 actionable genomic alteration

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

Excluded: NTRK3 actionable genomic alteration

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

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

Must have adequate laboratory parameters

Kidney function

Must have adequate laboratory parameters

Liver function

Must have adequate laboratory parameters

Must have adequate laboratory parameters

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Clearview Cancer Institute · Huntsville, Alabama
  • Banner MD Anderson Cancer Center · Gilbert, Arizona
  • Banner University Medical Center Phoenix · Phoenix, Arizona
  • The University of Arizona Cancer Center - North Campus · Tucson, Arizona
  • Highlands Oncology Group · Springdale, Arkansas

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06119581 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require KRAS?

Yes, KRAS G12C is a required biomarker for enrollment.

Are patients with EGFR alterations eligible?

No. EGFR actionable genomic alteration is an exclusion criterion.

Are patients with ALK alterations eligible?

No. ALK actionable genomic alteration is an exclusion criterion.

What disease stage is eligible?

Stage IIIB or IIIC or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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