A Phase 3 Study to Compare sotorasib with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutatio
Phase 3
Completed
- Conditions
- KRAS p, G12c Mutated /Advanced Metastatic NSCLC
- Registration Number
- JPRN-jRCT2080225266
- Lead Sponsor
- Amgen K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 345
Inclusion Criteria
1. Men or women greater than or equal to 18 years old.
2. ECOG <= 1
3. Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment
Exclusion Criteria
1. Active brain metastases
2. Myocardial infarction within 6 months of study day 1
3. Gastrointestinal (GI) tract disease causing the inability to take oral medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>1. Progression-free survival (PFS) [ Time Frame: Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months ]<br> PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).<br> As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to sotorasib, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
- Secondary Outcome Measures
Name Time Method