Informations générales (source: ClinicalTrials.gov)
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) (CEMI-LUNG)
Observational [Patient Registry]
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
octobre 2022
octobre 2028
05 avril 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Investigational Site Number: 250-001 - 67000 - Strasbourg - Bas-Rhin - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number: 250-002 - 75970 - Paris - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number: 250-003 - 49933 - Angers - Maine-et-Loire - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number: 250-004 - 13015 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number: 250-005 - 63000 - Clermont-Ferrand - Puy-de-Dôme - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number: 250-006 - 86021 - Poitiers - Vienne - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number: 250-007 - 68100 - Mulhouse - Haut-Rhin - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number: 250-008 - 72037 - Le Mans - Sarthe - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number: 250-009 - 84000 - Avignon - Vaucluse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. At least 18 years of age at the time of cemiplimab treatment initiation
2. Has been diagnosed with histologically or cytologically documented squamous or
non-squamous NSCLC
3. 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).
4. Can understand and complete the study-related questionnaires
5. Must be legally capable of providing written consent for participation in the study
and have signed informed consent prior to any study activities
Key
1. At least 18 years of age at the time of cemiplimab treatment initiation
2. Has been diagnosed with histologically or cytologically documented squamous or
non-squamous NSCLC
3. 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).
4. Can understand and complete the study-related questionnaires
5. Must be legally capable of providing written consent for participation in the study
and have signed informed consent prior to any study activities
Key
1. Has received cemiplimab prior to enrollment
2. Has uncontrolled autoimmune disease
3. Has a contraindication to cemiplimab as noted in the local SmPC
4. Is concurrently participating in any other study of an investigational drug or
procedure
5. 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