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

  • Interventional
  • Recruiting
  • NCT04613596
Eligibility Details Visit Clinicaltrials.gov

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

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.

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT04613596

IRB#IRB21-0638

Lead SponsorMirati Therapeutics Inc.

Lead PhysicianMarina Chiara Garassino

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting