Study name: J3M-MC-JZQH: 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
Histology
NSCLC, all subtypes
Tumor stage
Stage I - III
Host / recruiting site 1
Amsterdam UMC
Enrollment
Planned
Design
Both Part A and B are randomized, double-blind, placebo-controlled.
Intervention
Experimental: Part A: Olomorasib + Pembrolizumab Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
Placebo Comparator: Part A: Placebo + Pembrolizumab Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
Experimental: Part B: Olomorasib + Durvalumab Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
Placebo Comparator: Part B: Placebo + Durvalumab Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
Key outcome parameters
Part A: Disease-Free Survival (DFS) by Investigator Assessment Part B: Progression-Free Survival (PFS) Part A & B: Overall Survival (OS)
Key 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
Key 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.
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