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
Recruiting · NCT05363319 · Observational (researchers observe without assigning treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
49 locations listed.
- Hospital Torrecardenas - Almería, Spain
- Centre Hospitalier Universitaire Angers - Angers, France
- Gemeinschaftskrankenhaus Havelhoehe - Berlin, Germany
- AO Universitaria Policlinico Vittorio Emanuele - Catania, Italy
- Center Hospitalier Universitaire (CHU) of Clermont - Clermont-Ferrand, France
- Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos) - Dortmund, Germany
- Krankenhaus Martha-Maria Halle-Doelau gGmbH - Halle, Germany
- University Hospital of Jaen - Jaén, Spain
- Centre Hospitalier - Le mans - Le Mans, France
- Hospital Arnau de Vilanova - Lleida, Spain
- Marienhaus Klinikum Mainz - Mainz, Germany
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan, Italy
- Azienda Ospedaliero-Universitaria di Modena - Modena, Italy
- AORN dei Colli - Naples, Italy
- Istituto Nazionale Tumori IRCCS Fondazione G Pascale - Naples, Italy
- Hopital Tenon - Paris, France
- Fondazione IRCCS Policlinico San Matteo - Pavia, Italy
- Salzburger Landeskliniken (SALK) - Salzburg, Austria
- Hospital Universitario Nuestra Senora de Candelaria - Santa Cruz de Tenerife, Spain
- Azienda Sanitaria Locale (ASL) Taranto - Taranto, Italy
- Hospital Universitari Sant Joan de Reus - Tarragona, Spain
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia - Udine, Italy
- Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital - Mulhouse, Alsace, France
- Hospital Universitario Virgen De La Victoria Malaga - Málaga, Andalusia, Spain
- Klinikum Konstanz - Konstanz, Baden-Wurttemberg, Germany
- MedFISMO - Weinsberg, Baden-Wurttemberg, Germany
- Parc Tauli Sabadell Hospital Universitari - Sabadell, Barcelona, Spain
- Hopitaux Universitaires de Strasbourg - Strasbourg, Bas-Rhin, France
- Staedtisches Klinikum Muenchen Bogenhausen - München, Bavaria, Germany
- Nuremberg Hospital, Campus North - Nuremberg, Bavaria, Germany
- APHM - Hopital Nord - Marseille, Bouches-du-Rhône, France
- Hospital Universitario De Jerez - Jerez de la Frontera, Cadiz, Spain
- Klinikum Klagenfurt - Klagenfurt, Carinthia, Austria
- Consorcio Hospitalario Provincial de Castellon - Castellon, Castellon, Spain
- Humanitas Istituto Clinico Catanese - Misterbianco, Catania, Italy
- AOU Careggi - Florence, Firenze, Italy
- Complejo Hospitalario Universitario de Ferrol - Hospital Naval - Ferrol, Galicia, Spain
- Hospital Universitario Alvaro Cunqueiro - Vigo, Galicia, Spain
- Franziskus Hospital Harderberg - Georgsmarienhütte, Georgsmarienhuette, Germany
- Agaplesion Diakonieklinikum Rotenburg - Rotenburg (Wümme), Lower Saxony, Germany
- IRCCS Humanitas Research Hospital - Rozzano, Milan, Italy
- St. Franziskus Hospital Münster - Münster, North Rhine-Westphalia, Germany
- Haematologisch Onkologische Schwerpunktpraxis - Troisdorf - Troisdorf, North Rhine-Westphalia, Germany
- San Luigi Gonzaga University Hospital - Orbassano, Piedmont, Italy
- Klinikum Chemnitz gGmbH - Chemnitz, Saxony, Germany
- Pneumologische Praxis PD Dr. Med Christian Gessner - Leipzig, Saxony, Germany
- Ospedale Di Cisanello Azienda Ospedaliero Universitaria - Pisa, Tuscany, Italy
- Sainte Catherine Institut du Cancer Avignon Provence - Avignon, Vaucluse, France
- Centre Hospitalier Universitaire (CHU) de Poitiers - Poitiers, Vienne, France