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)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Non-Small Cell Lung Cancer (NSCLC)
Спонсор: Amgen
Налично на:
БГ
Обобщение
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.
Кой може да участва
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
Интервенции
Sotorasib
DRUG
Pembrolizumab
DRUG
Места на провеждане
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
БГ
EN