Clinical Trial Details
A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02
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.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
Inclusion Criteria:
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Histological or cytological confirmation of NSCLC.
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Part A
- 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.
- Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.
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Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
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Must have disease with evidence of KRAS G12C mutation.
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Must have known programmed death-ligand 1 (PD-L1) expression
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Must have an ECOG performance status of 0 or 1.
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Able to swallow oral medication.
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Must have adequate laboratory parameters.
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Contraceptive use should be consistent with local regulations for those participating in clinical studies.
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Women of childbearing potential must
- Have a negative pregnancy test.
- Not be breastfeeding during treatment
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.
- 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.
