A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
- Conditions
- on-Small Cell Lung Cancer (NSCLC)
- Registration Number
- JPRN-jRCT2061230078
- Lead Sponsor
- akatani Iwami
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 750
1. Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p.G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
2. No history of systemic anticancer therapy in metastatic/non-curable settings
3. Eastern Cooperative Oncology Group (ECOG) <= 1
1. Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
2. Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved
3. Symptomatic (treated or untreated) brain metastases
4. Gastrointestinal (GI) tract disease causing the inability to take oral medication
5. Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
6. Prior therapy with a KRAS G12C inhibitor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Progression-free Survival (PFS) [ Time Frame: From Baseline up to end of study (EOS) (approximately 5.5 years) ]<br>PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
- Secondary Outcome Measures
Name Time Method