Clinical Trials /

Phase 2 Trial of MRTX849 Plus Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7

NCT04613596

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 2 Trial of MRTX849 Plus Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7
  • Official Title: A Phase 2 Trial of MRTX849 in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Clinical Trial IDs

  • ORG STUDY ID: 849-007
  • NCT ID: NCT04613596

Conditions

  • Advanced Non-Small Cell Lung Cancer
  • Metastatic Cancer

Interventions

DrugSynonymsArms
MRTX849 in Combination with PembrolizumabPhase 2 Combination with Pembrolizumab TPS <1% , TPS >/= 1%

Purpose

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

Detailed Description

      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.

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Phase 2 Combination with Pembrolizumab TPS <1% , TPS >/= 1%ExperimentalA Phase 2 MRTX849 in combination with pembrolizumab in patients with NSCLC
  • MRTX849 in Combination with Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C
             mutation and known PD-L1 Tumor Proportion Score (TPS) score.

          -  Unresectable or metastatic disease.

        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).

          -  Active brain metastases.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate the clinical activity of MRTX849 in combination with pembrolizumab
Time Frame:11 months
Safety Issue:
Description:Objective Response Rate (ORR) RECIST 1.1

Secondary Outcome Measures

Measure:To characterize the safety and tolerability of the combination regimen in the selected population.
Time Frame:11 months
Safety Issue:
Description:Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
Measure:Duration of Response (DOR)
Time Frame:11 months
Safety Issue:
Description:MRTX849 in combination with pembrolizumab

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mirati Therapeutics Inc.

Trial Keywords

  • KRAS G12C
  • Non-small cell lung cancer
  • NSCLC
  • Metastatic Cancer

Last Updated

January 7, 2021