Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7

Official Title

A Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Summary:

This Phase 2 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.

Trial Description

Primary Outcome:

  • Evaluate the efficacy of MRTX849 monotherapy in advanced/metastatic NSCLC with PDL1 <1%, and efficacy of MRTX849 in combination with pembrolizumab, based on the Objective Response Rate (ORR) using RECIST version 1.1
Secondary Outcome:
  • To characterize the safety and tolerability of the monotherapy and combination regimen in the selected population.
  • Duration of Response (DOR)
  • Pharmacokinetics (PK) Blood plasma MRTX849 and potential metabolite concentrations
This Phase 2 study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C mutation, have advanced or metastatic NSCLC, and are candidates for first-line treatment. 2 cohorts have PDL-1 TPS score <1% and are randomized to MRTX849 monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort has PDL-1 TPS score of 1% or higher and is treated with MRTX849 and pembrolizumab

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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society