Phase 2 Trial of MRTX849 Plus Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7
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|ClinicalTrials.gov Identifier: NCT04613596|
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : July 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Non-Small Cell Lung Cancer Metastatic Cancer||Drug: MRTX849 in Combination with Pembrolizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||MRTX849 in Combination with Pembrolizumab|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 2, 2020|
|Estimated Primary Completion Date :||October 30, 2022|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: Phase 2 Combination with Pembrolizumab TPS <1% , TPS >/= 1%
A Phase 2 MRTX849 in combination with pembrolizumab in patients with NSCLC
Drug: MRTX849 in Combination with Pembrolizumab
MRTX849 Inhibitor will be administered orally twice daily in a continuous regimen.
Pembrolizumab is administered as an intravenous infusion once every 3 weeks
- Evaluate the clinical activity of MRTX849 in combination with pembrolizumab [ Time Frame: 11 months ]Objective Response Rate (ORR) RECIST 1.1
- To characterize the safety and tolerability of the combination regimen in the selected population. [ Time Frame: 11 months ]Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
- Duration of Response (DOR) [ Time Frame: 11 months ]MRTX849 in combination with pembrolizumab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613596
|Contact: Mirati Therapeutics Study Locator Servicesfirstname.lastname@example.org|
|Study Director:||Richard L Chao, MD||Mirati Therapeutics Inc.|