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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 a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe

NCT05363319

RecruitingN/A

Sponsor: Regeneron Pharmaceuticals

Conditions: Non-small Cell Lung Cancer

Interventions: Cemiplimab, Platinum-based chemotherapy

Countries: Austria, France, Germany, Italy, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Key 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 Exclusion Criteria:

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
Locations (49)
  • Klagenfurt, Carinthia, Austria
  • Salzburg, Austria
  • Mulhouse, Alsace, France
  • Strasbourg, Bas-Rhin, France
  • Marseille, Bouches-du-Rhône, France
  • Avignon, Vaucluse, France
  • Poitiers, Vienne, France
  • Angers, France
  • Clermont-Ferrand, France
  • Le Mans, France
  • Paris, France
  • Konstanz, Baden-Wurttemberg, Germany
  • Weinsberg, Baden-Wurttemberg, Germany
  • München, Bavaria, Germany
  • Nuremberg, Bavaria, Germany
  • Georgsmarienhütte, Georgsmarienhuette, Germany
  • Rotenburg (Wümme), Lower Saxony, Germany
  • Münster, North Rhine-Westphalia, Germany
  • Troisdorf, North Rhine-Westphalia, Germany
  • Chemnitz, Saxony, Germany
  • Leipzig, Saxony, Germany
  • Berlin, Germany
  • Dortmund, Germany
  • Halle, Germany
  • Mainz, Germany
  • Misterbianco, Catania, Italy
  • Florence, Firenze, Italy
  • Rozzano, Milan, Italy
  • Orbassano, Piedmont, Italy
  • Pisa, Tuscany, Italy
  • + 19 more on CT.gov