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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) — CEMI-LUNG  

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)

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05363319
Study type Observational [Patient Registry]
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Status Recruiting
Phase
Start date October 27, 2022
Completion date October 27, 2028
View Details
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