Status:
RECRUITING
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
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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 le...
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 ...
Eligibility Criteria
Inclusion
- Key
- At least 18 years of age at the time of cemiplimab treatment initiation
- Has been diagnosed with histologically or cytologically documented squamous or non-squamous NSCLC
- Prescribed a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the Summary of Product Characteristics (SmPC).
- Can understand and complete the study-related questionnaires
- Must be legally capable of providing written consent for participation in the study and have signed informed consent prior to any study activities
- Key
Exclusion
- Has received cemiplimab prior to enrollment
- Has uncontrolled autoimmune disease
- Has a contraindication to cemiplimab as noted in the local SmPC
- Is concurrently participating in any other study of an investigational drug or procedure
- Has cognitive impairment or other medical condition that, in the opinion of the investigator, would interfere with the ability to complete the study-related questionnaires
- NOTE: Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
October 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05363319
Start Date
October 26 2022
End Date
October 30 2028
Last Update
December 9 2025
Active Locations (48)
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1
Klinikum Klagenfurt
Klagenfurt, Carinthia, Austria, 9020
2
Salzburger Landeskliniken (SALK)
Salzburg, Salzburg, Austria, 5020
3
Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
Mulhouse, Alsace, France, 68100
4
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Nouvelle-Aquitaine, France, 86021