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Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Trial Status: active
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.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06890598.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not Available
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Approved
Name Not Available
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center