Phase II study of MRTX849 monotherapy and in combination with pembrolizumab in patients with advanced non-small-cell lung cancer with KRAS G12C mutatio
Phase 2
- Conditions
- Advanced non-small cell lung cancerCancer
- Registration Number
- ISRCTN13464104
- Lead Sponsor
- Mirati Therapeutics (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
1. Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and known PD-L1 Tumor Proportion Score (TPS) score
2. Unresectable or metastatic disease
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 Objective Response Rate (ORR) assessed using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 at 22 months
- Secondary Outcome Measures
Name Time Method <br> 1. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities at 22 months<br> 2. Duration of response (DOR) estimated using the Kaplan-Meier method at 22 months<br> 3. Pharmacokinetics (PK) of MRTX849 administered as monotherapy and in combination with pembrolizumab by measuring blood plasma MRTX849 and potential metabolite concentrations at 22 months<br>