A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plus Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutatio
Phase 2
Recruiting
- Conditions
- Advanced Pulmonary Non-Small Cell CancerMetastatic Non-Small Cell Lung Cancer10038666
- Registration Number
- NL-OMON54311
- Lead Sponsor
- Mirati Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
Histologically confirmed diagnosis of unresectable or metastatic NSCLC with
KRAS G12C mutation and any PD-L1 TPS.
Exclusion Criteria
1. 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).
2. Active brain metastases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objective Response Rate (ORR) as defined by Response Evaluation Criteria in<br /><br>Solid tumors version 1.1 (RECIST 1.1) by Investigator </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Safety characterized by type, incidence, severity, timing, seriousness and<br /><br>relationship to study treatment of AE's and laboratory abnormailities<br /><br>- Plasma MRTX849 and potential metabolite concentrations<br /><br>- Duration of Response (DOR) by Investigator<br /><br>- Progression-Free Survival (PFS) by Investigator<br /><br>- 1-Year Survival Rate<br /><br>- Overall Survival (OS)</p><br>