Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Advanced Non-Small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer KRAS G12C Non-small cell lung cancer NSCLC Adagrasib Lung Neoplasms Carcinoma, Non-Small-Cell Lung Pembrolizumab MRTX849 Monotherapy MRTX849 in Combination with Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Research Site accepting new patients
    San Francisco California 94143 United States
  • Research Site accepting new patients
    Santa Rosa California 95403 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
ID
NCT04613596
Phase
Phase 2 Research Study
Study Type
Interventional
Participants
Expecting 250 study participants
Last Updated