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
mars 2031
18 octobre 2024
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.
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 | 04/09/2024 13:49:38 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Ambroise Paré | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Cancerologie du Grand Montpellier-Clinique Clementville - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier - Le Mans - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Cornouaille - 29000 - Quimper - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Departemental Les Oudairies - 85925 - La Roche sur Yon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz - 25030 - Besancon cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon - 59037 - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau - 37044 - Tours Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque - 33604 - Pessac Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie - 86021 - Poitiers Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Reims - Hopital Christian Cabrol - 51092 - Reims Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle - 76031 - Rouen Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord - 42270 - Saint Priest en Jarez - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil - 67091 - Strasbourg cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Toulouse - Hopital Larrey - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Nord - 13915 - Marseille Cedex 20 - France | Contact (sur clinicalTrials) | ||||
| Hopital d instruction des armees sainte anne - 83800 - Toulon - France | Contact (sur clinicalTrials) | ||||
| Hopital Nord-Ouest Villefranche - 69400 - Villefranche Sur Saone Cedex - France | Contact (sur clinicalTrials) | ||||
| Hopital prive du Confluent - 44277 - Nantes Cedex 2 - France | Contact (sur clinicalTrials) | ||||
| Hopital Universitaire Caremeau - 30029 - Nimes cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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