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 3 – large-scale trial before approval
Conditions:
Carcinoma, Non-Small-Cell Lung
Sponsor: Eli Lilly and Company
trial.available_in:
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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.
Who can participate
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 2 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.
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