Tests sotorasib with chemotherapy against pembrolizumab with chemotherapy in lung cancer
Tests sotorasib with chemotherapy in adults with advanced KRAS G12C lung cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Bayonne, Besancon Cedex, Boulogne-Billancourt, Brest, Caen Cedex 9, Chambéry, Créteil, La Roche Sur Yon Cedex 9, Le Mans Cedex 9, Lille, Marseille, Montpellier, Nantes Cedex 2, Nice Cedex 2, Nîmes, Orleans Cedex 2, Paris, Paris Cedex 14, Paris Cedex 20, Pessac, Poitiers, Quimper Cedex, Reims Cedex, Rennes, Rouen Cedex, Saint-Grégoire, Saint-Priest-en-Jarez, Strasbourg Cedex, Toulon Cedex 9, Toulouse, Toulouse Cedex 3, Tours Cedex 9, Villefranche sur Saône, and Villejuif, FranceSee the 36 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- What was the PD-L1 result of your tumour test?
- Has your cancer spread to the brain?
Source: NCT05920356, who can take part
Where in France
- Centre Hospitalier de la Cote BasqueBayonne, FranceTaking people
- Besancon University Hospital CenterBesancon Cedex, FranceTaking people
- Hôpital Ambroise-ParéBoulogne-Billancourt, FranceTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranceTaking people
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- Centre Hospitalier Métropole SavoieChambéry, FranceTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceTaking people
- Centre Hospitalier Le MansLe Mans Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire de LilleLille, FranceTaking people
- Assistance Publique Hôpitaux de MarseilleMarseille, FranceTaking people
- Hôpital Saint JosephMarseille, FranceTaking people
- Centre de Cancérologie du Grand MontpellierMontpellier, FranceTaking people
- L'Hopital Prive Du ConfluentNantes Cedex 2, FranceTaking people
- Centre Antoine LacassagneNice Cedex 2, FranceTaking people
- Centre Hospitalier Universitaire de NîmesNîmes, FranceTaking people
- Centre Hospitalier Universitaire D OrleansOrleans Cedex 2, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Institut CurieParis, FranceTaking people
- GIE Groupe hospitalier Paris Saint-JosephParis Cedex 14, FranceTaking people
- Hopital TenonParis Cedex 20, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Centre Hospitalier Intercommunal De CornouailleQuimper Cedex, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims Cedex, FranceTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranceTaking people
- CHU De RouenRouen Cedex, FranceTaking people
- Centre Hospitalier Prive Saint GregoireSaint-Grégoire, FranceTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranceTaking people
- Direction Centrale Du Service De Sante Des ArmeesToulon Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
- Clinique PasteurToulouse Cedex 3, FranceTaking people
- Centre Hospitalier Regional Universitaire De ToursTours Cedex 9, FranceTaking people
- Hopital Nord-Oest - Villefranche sur SaôneVillefranche sur Saône, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT05920356EU 2022-501863-41-00
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy; Prior therapy with a KRAS G12C inhibitor; Gastrointestinal (GI) tract disease causing the inability to take oral medication; Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina; Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology; Symptomatic (treated or untreated) brain metastases.