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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
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Advanced Non-Small Cell Lung Cancer Metastatic Cancer Drug: MRTX849 in Combination with Pembrolizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: MRTX849 in Combination with Pembrolizumab
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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





Primary Outcome Measures :
  1. Evaluate the clinical activity of MRTX849 in combination with pembrolizumab [ Time Frame: 11 months ]
    Objective Response Rate (ORR) RECIST 1.1


Secondary Outcome Measures :
  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.

  2. Duration of Response (DOR) [ Time Frame: 11 months ]
    MRTX849 in combination with pembrolizumab



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mirati Therapeutics Study Locator Services 18448935530 miratistudylocator@emergingmed.com

Locations
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Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Richard L Chao, MD Mirati Therapeutics Inc.
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04613596    
Other Study ID Numbers: 849-007
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mirati Therapeutics Inc.:
KRAS G12C
Non-small cell lung cancer
NSCLC
Metastatic Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Pembrolizumab
Adagrasib
Antineoplastic Agents, Immunological
Antineoplastic Agents