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
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
Drug | Synonyms | Arms |
---|
MRTX849 in Combination with Pembrolizumab | | Phase 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
Name | Type | Description | Interventions |
---|
Phase 2 Combination with Pembrolizumab TPS <1% , TPS >/= 1% | Experimental | A 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
July 28, 2021