NCT05920356Recruiting
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)
Summary
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 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 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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Greece, Hong Kong, Hungary, Japan, Latvia, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
- Sponsor
- Amgen(Industry)
- Protocol no.
- 20190341
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- Drug
Treatments studied
- Sotorasib
- Pembrolizumab
Locations · 318
- Baden, SwitzerlandKantonsspital BadenRecruiting at this site
- Zurich, SwitzerlandUniversitaetsspital ZuerichRecruiting at this site
- Bayonne, FranceCentre Hospitalier de la Cote BasqueRecruiting at this site
- Besançon, FranceCentre Hospitalier Regional Universitaire de Besancon - Hopital Jean MinjozRecruiting at this site
- Boulogne-Billancourt, FranceCentre Hospitalier Universitaire Ambroise PareRecruiting at this site
- Brest, FranceCentre Hospitalier Universitaire de Brest - Hopital Cavale BlancheRecruiting at this site
- Caen, FranceCentre Hospitalier Universitaire de Caen - Hopital Cote de NacreRecruiting at this site
- Chambéry, FranceCentre Hospitalier Metropole SavoieRecruiting at this site
- Créteil, FranceCentre Hospitalier Intercommunal de CreteilRecruiting at this site
- La Roche-sur-Yon, FranceCentre Hospitalier Departemental Les OudairiesRecruiting at this site
- Le Mans, FranceCentre Hospitalier - Le MansRecruiting at this site
- Lille, FranceCentre Hospitalier Régional Universitaire de Lille - Institut Coeur PoumonRecruiting at this site
- Marseille, FranceHopital Saint JosephRecruiting at this site
- Marseille, FranceCentre Hospitalier Universitaire NordRecruiting at this site
- Montpellier, FranceCentre de Cancerologie du Grand Montpellier-Clinique ClementvilleRecruiting at this site
- Nantes, FranceHopital prive du ConfluentRecruiting at this site
- Nîmes, FranceHopital Universitaire CaremeauRecruiting at this site
- Orléans, FranceCentre Hospitalier Regional d OrleansRecruiting at this site
- Paris, FranceInstitut CurieRecruiting at this site
- Paris, FranceGroupe Hospitalier Paris Saint JosephRecruiting at this site
- Paris, FranceHopital TenonRecruiting at this site
- Poitiers, FranceCentre Hospitalier Universitaire de Poitiers - Hopital la MiletrieRecruiting at this site
- Reims, FranceCentre Hospitalier Universitaire de Reims - Hopital Christian CabrolRecruiting at this site
- Rennes, FranceCentre Hospitalier Universitaire de Rennes - Hopital PontchaillouRecruiting at this site
- Saint-Grégoire, FranceCentre Hospitalier Prive Saint GregoireRecruiting at this site
- Saint-Priest-en-Jarez, FranceCentre Hospitalier Universitaire de Saint Etienne - Hopital NordRecruiting at this site
- Strasbourg, FranceCentre Hospitalier Universitaire de Strasbourg - Nouvel Hopital CivilRecruiting at this site
- Toulon, FranceHopital d instruction des armees sainte anneRecruiting at this site
- Toulouse, FranceCentre Hospitalier Universitaire de Toulouse - Hopital LarreyRecruiting at this site
- Tours, FranceCentre Hospitalier Regional Universitaire de Tours - Hopital BretonneauRecruiting at this site
In total, worldwide, 318 of the 424 sites listed in the registry are recruiting; the other 106 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 23, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 288 more locations
Other identifiers
- 2022-501863-41-00 · CTIS number
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.