Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutatio
- 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
- EUCTR2020-003645-11-PL
- Lead Sponsor
- Mirati Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
• Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
• Candidacy to receive treatment with docetaxel.
Crossover Inclusion Criteria
1.Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
2.ECOG performance status 0 - 2.
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 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225
• Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, sotorasib).
• Active brain metastases.
Crossover Exclusion Criteria:
1. Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method