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)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05920356Tipo: INTERVENTIONALInicio: 16 de nov de 2023Fin estimado: 30 de jun de 2031

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Sotorasib

Oral administration

drug

Pembrolizumab

Intravenous administration

Ubicaciones

Hospital Britanico de Buenos Aires

CABA, Buenos Aires, Argentina

TERMINATED

Instituto Alexander Fleming

Capital Federal, Buenos Aires, Argentina

RECRUITING

Instituto Argentino de Diagnostico y Tratamiento IADT

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

RECRUITING

Fundacion Ars Medica

San Salvador de Jujuy, Jujuy Province, Argentina

RECRUITING

Clinica Viedma

Viedma, Río Negro Province, Argentina

RECRUITING

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

RECRUITING

Sanatorio Parque SA

Rosario, Santa Fe Province, Argentina

RECRUITING

Centro Oncologico Korben

Buenos Aires, Argentina

RECRUITING

Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer

La Rioja, Argentina

RECRUITING

Centro de Diagnostico Investigacion y Tratamiento

Salta, Argentina

RECRUITING

Patrocinadores

PrincipalAmgen

Contactos

Amgen Call Center

CONTACT

medinfo@amgen.com 866-572-6436

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