RECRUITINGOBSERVATIONAL
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Key Who May Qualify:
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 willing to sign a consent form prior to any study activities
Key Who Should NOT Join This Trial:
1. Has received cemiplimab prior to enrollment
2. Has uncontrolled autoimmune conditions (where your immune system attacks your own body)
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Cemiplimab
solution for injection via intravenous (IV) infusion
DRUG
Platinum-based chemotherapy
IV administration
Locations (20)
Klinikum Klagenfurt
Klagenfurt, Carinthia, Austria
Salzburger Landeskliniken (SALK)
Salzburg, Austria
Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
Mulhouse, Alsace, France
APHM - Hopital Nord
Marseille, Bouches-du-Rhône, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Nouvelle-Aquitaine, France
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, Vaucluse, France
Centre Hospitalier Universitaire Angers
Angers, France
Center Hospitalier Universitaire (CHU) of Clermont
Clermont-Ferrand, France
Centre Hospitalier - Le mans
Le Mans, France
Hopital Tenon
Paris, France
Hopitaux Universitaires de Strasbourg
Strasbourg, France
Klinikum Konstanz
Konstanz, Baden-Wurttemberg, Germany
MedFISMO
Weinsberg, Baden-Wurttemberg, Germany
Staedtisches Klinikum Muenchen Bogenhausen
München, Bavaria, Germany
Franziskus Hospital Harderberg
Georgsmarienhütte, Georgsmarienhuette, Germany
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme), Großhansdorf, Schleswig-Holstein, Germany
St. Franziskus Hospital Münster
Münster, North Rhine-Westphalia, Germany
Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
Troisdorf, North Rhine-Westphalia, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Gemeinschaftskrankenhaus Havelhoehe
Berlin, Germany