NCT05363319

An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe

An Observational Study to Assess the Effectiveness and Safety of Cemiplimab Based Regimen in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care. The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.

Detailed description

Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023. The recruitment period will be 48 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 24 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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	solution for injection via intravenous (IV) infusion
DRUG	Platinum-based chemotherapy	IV administration

Timeline

• Start date: 2022-10-26
• Primary completion: 2028-10-30
• Completion: 2028-10-30
• First posted: 2022-05-05
• Last updated: 2026-03-18

Locations

49 sites across 5 countries: Austria, France, Germany, Italy, Spain