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
NCT ID: NCT05363319
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-10-26
2028-10-30
Brief Summary
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The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.
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Detailed Description
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The recruitment period will be 48 months. Data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 24 months after cemiplimab discontinuation. Patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Cemiplimab monotherapy
Cemiplimab
solution for injection via intravenous (IV) infusion
Cohort 2
Cemiplimab in combination with platinum-based chemotherapy
Cemiplimab
solution for injection via intravenous (IV) infusion
Platinum-based chemotherapy
IV administration
Interventions
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Cemiplimab
solution for injection via intravenous (IV) infusion
Platinum-based chemotherapy
IV administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Klinikum Klagenfurt
Klagenfurt, Carinthia, Austria
Salzburger Landeskliniken (SALK)
Salzburg, Salzburg, Austria
Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
Mulhouse, Alsace, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Nouvelle-Aquitaine, France
APHM - Hopital Nord
Marseille, Provenza, France
Hopitaux Universitaires de Strasbourg
Strasbourg, Strasbourg, France
Centre Hospitalier Universitaire Angers
Angers, , France
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, , France
Center Hospitalier Universitaire (CHU) of Clermont
Clermont-Ferrand, , France
Centre Hospitalier - Le mans
Le Mans, , France
Hopital Tenon
Paris, , 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
Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
Dortmund, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, , Germany
Pneumologische Praxis PD Dr. Med Christian Gessner
Leipzig, , Germany
Marienhaus Klinikum Mainz
Mainz, , Germany
Nuremberg Hospital, Campus North
Nuremberg, , Germany
AO Universitaria Policlinico Vittorio Emanuele
Catania, Catania, Italy
Humanitas Istituto Clinico Catanese
Misterbianco, Catania, Italy
AOU Careggi
Florence, Firenze, Italy
IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, Modena, Italy
AORN dei Colli
Napoli, Napoli, Italy
Istituto Nazionale Tumori IRCCS Fondazione G Pascale
Napoli, Napoli, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy
San Luigi Gonzaga University Hospital
Orbassano, Piedmont, Italy
Azienda Sanitaria Locale (ASL) Taranto
Taranto, Taranto, Italy
Ospedale Di Cisanello Azienda Ospedaliero Universitaria
Pisa, Tuscany, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Hospital Torrecardenas
Almería, Almería, Spain
Hospital Universitario Virgen De La Victoria Malaga
Málaga, Andalusia, Spain
Parc Tauli Sabadell Hospital Universitari
Sabadell, Barcelona, Spain
Hospital Universitario De Jerez
Jerez de la Frontera, Cadiz, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, Castellon, Spain
Complejo Hospitalario Universitario de Ferrol - Hospital Naval
Ferrol, Galicia, Spain
Hospital Universitario Alvaro Cunqueiro
Vigo, Pontevedra, Spain
University Hospital of Jaen
Jaén, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitari Sant Joan de Reus
Tarragona, , Spain
Countries
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Central Contacts
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Other Identifiers
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U1111-1275-9867
Identifier Type: REGISTRY
Identifier Source: secondary_id
R2810-ONC-2325
Identifier Type: -
Identifier Source: org_study_id
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