Non-small Cell Lung Cancer Clinical Trial
Official title:
An Observational Study to Assess the Effectiveness and Safety of Cemiplimab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)
Primary Objective: Describe the overall survival rate (OS) rate in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice. Secondary Objectives: - To describe the following in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice: - Objective response rate (ORR) - Time to response (TTR) - Time to progression - Time to first subsequent anti-NSCLC treatment (TTST) - Duration of response (DoR) - Progression-free Survival (PFS) - Incidence and severity of adverse events (AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023. The recruitment period will be 36 months. Data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 36 months after cemiplimab discontinuation. Patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first. ;
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