Phase 2 Study of MRTX849 Plus Pembrolizumab in Patients with AdvancedNon-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-IT
- Lead Sponsor
- MIRATI THERAPEUTICS INCORPORATED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1.Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and
2. known PD-L1 Tumor Proportion Score (TPS) score.
3.Unresectable or metastatic disease.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
Exclusion Criteria
1.Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, 2. immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
3. 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 clinical activity of MRTX849 in combination with pembrolizumab administered in the first-line treatment setting to patients having NSCLC with KRAS G12C mutation.;Secondary Objective: -To characterize the safety and tolerability of the combination regimen in the selected population.<br>-To evaluate secondary efficacy endpoints using the combination regimen in the selected population.<br>-To evaluate the pharmacokinetics (PK) of MRTX849 administered in combination with pembrolizumab.;Primary end point(s): Objective Response Rate (ORR);Timepoint(s) of evaluation of this end point: 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Safety<br>-Blood plasma MRTX849 and potential metabolite concentrations.<br>.Duration of Response (DOR)<br>.Progression-Free Survival (PFS)<br>.1-Year Survival Rate<br>.Overall Survival (OS);Timepoint(s) of evaluation of this end point: 24 months