Informations générales (source: ClinicalTrials.gov)
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
novembre 2023
juin 2031
02 octobre 2025
The primary objectives are to compare progression-free survival (PFS) and overall
survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy
versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:30:48 | Contacter | ||
| CLCC INSTITUT CURIE | 10/04/2025 13:12:08 | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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 as a front-line therapy
- 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