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Trial NCT06890598

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

Phase
Phase 3
Sponsor
Eli Lilly and Company
Conditions
Carcinoma, Non-Small-Cell Lung
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Histological or cytological confirmation of NSCLC. * Part A 1. Clinical Stage II-IIIB (N0, N1, 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 (N0, N1, 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.Performance status * 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 treatmentPregnancy Exclusion Criteria: * Have known, actionable changes in the EGFR or ALK genes. * Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.Prior malignancy * 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.

Restrictions found (3)

Recruiting in Massachusetts

  • Reliant Medical Group · Worcester, Worcester County