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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 (May 2026). This Phase 3 trial studies multiple treatments for carcinoma, non-small-cell lung.

Phase 3RecruitingEli Lilly and CompanyNCT06119581Data as of May 2026

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

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: KRAS G12C mutation

Must have disease with evidence of KRAS G12C mutation

Required: PD-L1 (CD274) expression ≥50% (≥50%)

Part A: Greater than or equal to (≥)50 percent (%)

Required: PD-L1 (CD274) expression 0% to 100% (0% to 100%)

Part B: 0% to 100%

Required: PD-L1 (CD274) expression <50% (<50%)

Part C: <50%

Required: EGFR validated targetable oncogenic driver mutation or alteration

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.

Required: ALK validated targetable oncogenic driver mutation or alteration

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.

Required: BRAF V600E

BRAF (V600E)

Required: HER2 (ERBB2) validated targetable oncogenic driver mutation or alteration

human epidermal growth factor receptor 2 (HER2)

Required: MET exon 14 mutation

MET (exon 14)

Required: ROS1 validated targetable oncogenic driver mutation or alteration

ROS1

Required: RET validated targetable oncogenic driver mutation or alteration

rearranged during transfection (RET)

Required: NTRK1 validated targetable oncogenic driver mutation or alteration

neurotrophic tyrosine receptor kinase (NTRK)1

Required: NTRK2 validated targetable oncogenic driver mutation or alteration

neurotrophic tyrosine receptor kinase (NTRK)2

Required: NTRK3 validated targetable oncogenic driver mutation or alteration

neurotrophic tyrosine receptor kinase (NTRK)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

Cannot have received: systemic therapy

Exception: 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated

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 →

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