Last updated 9 days ago
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)
750 patients around the world
Available in Brazil, Argentina, Chile, Colombia, Mexico
Amgen
44Research sites
750Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
To 100 Years
All Gender
Medical requirements
- 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 testingNo history of systemic anticancer therapy in metastatic/non-curable settingsEastern Cooperative Oncology Group (ECOG) ≤ 1
- Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histologyParticipants with tumors known to harbor molecular alterations for which targeted therapy is locally approvedSymptomatic (treated or untreated) brain metastasesGastrointestinal (GI) tract disease causing the inability to take oral medicationMyocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable anginaPrior therapy with a KRAS G12C inhibitor
Sites
Site Pen
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto Argentino de Diagnóstico y Tratamiento - IADT
Recruiting
Fundación Ars Médica - San Salvador de Jujuy
Recruiting
Sanatorio Parque - Rosario
Recruiting
Hospital Italiano de La Plata
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Selenium Site
Recruiting
StudyCodeBreaK 202
SponsorAmgen
Study typeInterventional
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
To 100 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05920356
