StudyFinder
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
RECRUITING
18 years and over
Inclusion Criteria:
* Histological or cytological confirmation of NSCLC.
* Part A
• 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.
• 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.DRUG: Olomorasib, DRUG: Pembrolizumab, DRUG: Durvalumab, DRUG: Placebo
Carcinoma, Non-Small-Cell Lung
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or - LillyTrials@Lilly.com
PHASE3
NCT06890598