Life sciences · Phase 2/3 Trial
ClinicalTrials.gov · September 16, 2026
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Phase 2/3 Trial.
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Registry record from ClinicalTrials.gov (NCT04613596). This is a study registration, not published results. Lead sponsor: Mirati Therapeutics Inc.. Recruitment status: RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 626 participants (ESTIMATED). Conditions: Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer. Interventions: DRUG: Adagrasib; DRUG: Adagrasib; DRUG: Adagrasib; DRUG: Adagrasib; DRUG: Pembrolizumab. Primary outcome measures: Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC. , 22 months; Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab , 36 months. Brief summary: The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.