Status:
RECRUITING
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
AstraZeneca
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 KRA...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2032
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06890598
Start Date
March 27 2025
End Date
February 1 2032
Last Update
December 17 2025
Active Locations (350)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
Infirmary Cancer Care
Mobile, Alabama, United States, 36607
3
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719
4
Highlands Oncology Group
Springdale, Arkansas, United States, 72762