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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
KRAS G12C Inhibitor
Olomorasib
Phase
3
Recruiting
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer
Related Resources:
Molecule Overview Trial Enrollment
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Key Inclusion Criteria
  • Histologically/cytologically confirmed non-small cell lung cancer (NSCLC)
  • For Part A:
    • Clinical Stage II-IIIB (N2) NSCLC treated via presurgical chemoimmunotherapy, with the residual tumor being present during surgery. Patients with a pathologic complete response are not eligible
    • Pathologic Stage II-IIIB (N2) NSCLC treated via initial upfront resection
  • For Part B:
    • Clinical Stage III unresectable NSCLC without progression on concurrent platinum-based chemotherapy
  • Disease with evidence of KRAS G12C mutation
  • Disease with evidence of programmed death-ligand 1 (PD-L1) expression
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Ability to swallow oral medication
  • Adequate laboratory parameters
  • Contraceptive use consistent with local regulations
  • Women of childbearing potential must
    • Have a negative pregnancy test
    • Not be breastfeeding during treatment
Key Exclusion Criteria
  • Known changes in the epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes
  • Another type of cancer that is either progressing or required active treatment in the last 3 years before screening
  • An active autoimmune disease that required systemic treatment in the past 2 years, with the exception of endocrine replacement therapy
  • Any immune-related side effect or allergic reaction (≥Grade 3) from a previous immunotherapy medicine or any unresolved >Grade 1 immune-related side effect, except in patients with hormone-related diseases who are now on stable hormone replacement therapy
a
Combination treatment for up to approximately 1 year followed by olomorasib/placebo monotherapy to complete up to 3 years of total treatment.
b
Administered orally BID up to 3 years.
c
Administered intravenously up to 1 year.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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