Study on Olomorasib with Standard Treatment for Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

Sponsor: Eli Lilly and Company

Sponsor score: 60

ClinicalTrials ID:NCT06890598

This clinical trial is testing whether the drug olomorasib, when combined with standard treatments, is more effective than standard treatments alone for patients with a specific type of lung cancer that has a KRAS G12C mutation.

Patient Parameters

Program Overview

The study aims to find out if adding olomorasib to standard treatments like pembrolizumab or durvalumab can better control non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. It involves patients whose cancer has been surgically removed or cannot be removed. The trial may last up to 3 years for each participant.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • For Part A: Have Stage II-IIIB cancer treated with chemoimmunotherapy before surgery, with some tumor remaining after surgery. Patients with no remaining tumor are not eligible.
  • For Part B: Have Stage III cancer that cannot be removed by surgery and has not worsened after chemotherapy and radiation.
  • Have a KRAS G12C mutation in the cancer.
  • Have known PD-L1 expression.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be able to swallow pills.
  • Have acceptable blood test results.
  • Use contraception as per local guidelines if applicable.
  • Women of childbearing potential must:
    • Have a negative pregnancy test.
    • Not breastfeed during treatment.

Exclusion Criteria

  • Have known changes in the EGFR or ALK genes.
  • Have another type of cancer that is getting worse or needed treatment in the last 3 years.
  • Have an active autoimmune disease that needed treatment in the last 2 years, except for hormone replacement therapy.
  • Have had severe immune-related side effects from previous immunotherapy, or any unresolved immune-related side effects, except for those 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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