Phase 2 Study of Adagrasib Monotherapy and in Combination With Pembrolizumab and Phase 3 Study of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plus Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutatio
Phase 1
- Conditions
- Advanced Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-003101-58-PT
- Lead Sponsor
- Mirati Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 950
Inclusion Criteria
Histologically confirmed diagnosis of of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 475
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 475
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.;Secondary Objective: •To characterize the safety and tolerability of the monotherapy and the combination regimen in the selected population.<br>•To evaluate secondary efficacy endpoints using monotherapy and the combination regimen in the selected population.<br>•To evaluate the pharmacokinetics (PK) of adagrasib administered as monotherapy and in combination with pembrolizumab.<br>;Primary end point(s): Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)<br>;Timepoint(s) of evaluation of this end point: 22 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities<br>• Duration of Response (DOR), Progression - Free Survival (PFS), 1-Year Survival rate, Overall Survival (OS)<br>• Pharmacokinetics (PK) Blood plasma MRTX849 and potential metabolite concentrations<br><br>;Timepoint(s) of evaluation of this end point: 22 months