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)
Sponsor: Amgen
Sponsor score: 60
ClinicalTrials ID:NCT05920356
This clinical trial evaluates progression-free survival in patients with advanced nonsquamous NSCLC with KRAS p.G12C mutation and negative PD-L1 expression. Eligible participants have not received prior systemic therapy in metastatic settings and have an ECOG score ≤ 1. The study compares oral sotorasib with intravenous pembrolizumab, both combined with platinum doublet chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Eligibility Criteria
Inclusion Criteria
- 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
- No history of systemic anticancer therapy in metastatic/non-curable settings
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
Exclusion Criteria
- Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
- Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved
- Symptomatic (treated or untreated) brain metastases
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
- Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
- Prior therapy with a KRAS G12C inhibitor
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Illinois Chicago | 60612 | Chicago | Illinois |
| Norton Cancer Institute - Brownsboro | 40241 | Louisville | Kentucky |
| Reliant Medical Group Inc | 01606 | Worcester | Massachusetts |
| University of New Mexico Cancer Center | 87131 | Albuquerque | New Mexico |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Duke University | 27710 | Durham | North Carolina |
| FirstHealth Cancer Center | 28374 | Pinehurst | North Carolina |
| University of Pittsburgh Medical Center | 15232 | Pittsburgh | Pennsylvania |
| University of Tennessee Medical Center Knoxville | 37920 | Knoxville | Tennessee |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
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