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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 -

Part A Primary To compare the efficacy of olomorasib in combination with pembrolizumab versus placebo with pembrolizumab Secondary To compare olomorasib in combination with pembrolizumab versus placebo with pembrolizumab for the following measures: efficacy, changes in HRQoL, safety, patient-reported tolerability Exploratory To assess changes in NSCLC-related symptoms between olomorasib in combination with pembrolizumab versus placebo with pembrolizumab To assess changes in health status between olomorasib in combination with pembrolizumab versus placebo with pembrolizumab To assess the relationship between biomarkers and clinical outcomes To measure changes in biomarkers in response to study intervention and after disease recurrence or progression To characterize the PK of olomorasib in combination with pembrolizumab To describe patient-reported symptomatic adverse events of olomorasib in combination with pembrolizumab versus placebo with pembrolizumab To describe participant experience with treatment Part B Primary To compare the efficacy of olomorasib in combination with durvalumab versus placebo with durvalumab Secondary To compare olomorasib in combination with durvalumab versus placebo with durvalumab for the following measures: Efficacy, Safety, Changes in Patient-Reported NSCLC Related Symptoms, Changes in HRQoL, Patient-Reported Tolerability Exploratory To compare changes in health status between olomorasib in combination with durvalumab versus placebo with durvalumab To assess the relationship between biomarkers and clinical outcomes To measure changes in biomarkers in response to study intervention and after disease recurrence or progression To characterize the PK of olomorasib in combination with durvalumab To describe symptomatic adverse effect profiles of olomorasib in combination with durvalumab versus placebo with durvalumab To describe participant experience with treatment

Phase

III

Recruitment Status

Current Studies