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

Sponsor: Eli Lilly and Company

Sponsor score: 60

ClinicalTrials ID:NCT06890598

This study evaluates olomorasib with pembrolizumab or durvalumab versus placebo combinations in KRAS G12C-mutant NSCLC. Eligible participants must have confirmed NSCLC, specific clinical stages, and KRAS G12C mutation. Interventions include oral olomorasib and placebo, and IV pembrolizumab and durvalumab. Participants must meet health criteria and contraceptive guidelines.

Patient Parameters

Program Overview

The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Eligibility Criteria

Inclusion Criteria

  • Histological or cytological confirmation of NSCLC.

    • Part A

      1. Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
      2. Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection.
    • 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 Criteria

  • Have known changes in the EGFR or ALK genes.
  • Have another type of cancer that is progressing or required active treatment within the past 3 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.

Locations

FACILITYZIPCITYSTATE
Clearview Cancer Institute35805HuntsvilleAlabama
The University of Arizona Cancer Center - North Campus85719TucsonArizona
Highlands Oncology Group72762SpringdaleArkansas
UCLA Hematology/Oncology - Santa Monica90404Los AngelesCalifornia
Profound Research LLC92056OceansideCalifornia
Stanford Cancer Center94304Palo AltoCalifornia
Kaiser Permanente San Diego Mission Road92108San DiegoCalifornia
BASS Cancer Center94598Walnut CreekCalifornia
Hartford Hospital (HH)06102HartfordConnecticut
Boca Raton Regional Hospital33486Boca RatonFlorida

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