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)
Phase 3 – large-scale trial before approval
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Amgen
trial.available_in:
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Overview
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.
Who can participate
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
Interventions
Sotorasib
DRUG
Pembrolizumab
DRUG
Locations
380
Argentina (11)
Centro Oncologico Korben
Buenos Aires
Hospital Britanico de Buenos Aires
CABA , Buenos Aires
COMPLETED
Instituto Alexander Fleming
Capital Federal , Buenos Aires
Instituto Argentino de Diagnostico y Tratamiento IADT
Ciudad Autónoma de Buenos Aires , Buenos Aires
Hospital Italiano de La Plata
La Plata , Buenos Aires
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
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