This Phase 2 study evaluates the safety, pharmacokinetics, and clinical activity of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
Name: MRTX849 in Combination with Pembrolizumab
Description: Objective Response Rate (ORR) RECIST 1.1
Measure: Evaluate the clinical activity of MRTX849 in combination with pembrolizumab Time: 11 monthsDescription: • Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
Measure: To characterize the safety and tolerability of the combination regimen in the selected population. Time: 11 monthsDescription: MRTX849 in combination with pembrolizumab
Measure: Duration of Response (DOR) Time: 11 monthsSequential Assignment
There is one SNP
A Phase 2 Trial of MRTX849 in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation. --- G12C ---
Phase 2 Trial of MRTX849 Plus Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7 This Phase 2 study evaluates the safety, pharmacokinetics, and clinical activity of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation Evaluate the clinical activity of MRTX849 in combination with pembrolizumab. --- G12C ---
Phase 2 Trial of MRTX849 Plus Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7 This Phase 2 study evaluates the safety, pharmacokinetics, and clinical activity of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation Evaluate the clinical activity of MRTX849 in combination with pembrolizumab. --- G12C --- --- G12C ---
Inclusion Criteria: - Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and known PD-L1 Tumor Proportion Score (TPS) score. --- G12C ---
Exclusion Criteria: - Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510). --- G12C ---
Advanced Non-Small Cell Lung Cancer Metastatic Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation. --- G12C ---
MRTX849 is an orally available small molecule inhibitor of KRAS G12C, and Pembrolizumab (KEYTRUDA®) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. --- G12C ---