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)
- Non-small Cell Lung Cancer
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Regeneron Pharmaceuticals
- Enrolment target
- 500
- Started
- 26 October 2022
- Main results due
- 30 October 2028
- Study sites
- 49
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(49)
Klinikum Klagenfurt
Klagenfurt, Carinthia, Austria
Recruiting
Salzburger Landeskliniken (SALK)
Salzburg, Austria
Recruiting
Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
Mulhouse, Alsace, France
Recruiting
Hopitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin, France
Recruiting
APHM - Hopital Nord
Marseille, Bouches-du-Rhône, France
Recruiting
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, Vaucluse, France
Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Vienne, France
Recruiting
Centre Hospitalier Universitaire Angers
Angers, France
Recruiting
Center Hospitalier Universitaire (CHU) of Clermont
Clermont-Ferrand, France
Completed
Centre Hospitalier - Le mans
Le Mans, France
Recruiting
Hopital Tenon
Paris, France
Recruiting
Klinikum Konstanz
Konstanz, Baden-Wurttemberg, Germany
Recruiting
MedFISMO
Weinsberg, Baden-Wurttemberg, Germany
Withdrawn
Staedtisches Klinikum Muenchen Bogenhausen
München, Bavaria, Germany
Recruiting
Nuremberg Hospital, Campus North
Nuremberg, Bavaria, Germany
Completed
Franziskus Hospital Harderberg
Georgsmarienhütte, Georgsmarienhuette, Germany
Recruiting
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme), Lower Saxony, Germany
Recruiting
St. Franziskus Hospital Münster
Münster, North Rhine-Westphalia, Germany
Recruiting
Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
Troisdorf, North Rhine-Westphalia, Germany
Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Withdrawn
Pneumologische Praxis PD Dr. Med Christian Gessner
Leipzig, Saxony, Germany
Recruiting
Gemeinschaftskrankenhaus Havelhoehe
Berlin, Germany
Recruiting
Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
Dortmund, Germany
Recruiting
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, Germany
Recruiting
Marienhaus Klinikum Mainz
Mainz, Germany
Withdrawn
Humanitas Istituto Clinico Catanese
Misterbianco, Catania, Italy
Recruiting
AOU Careggi
Florence, Firenze, Italy
Recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, Italy
Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy
Recruiting
San Luigi Gonzaga University Hospital
Orbassano, Piedmont, Italy
Recruiting
Ospedale Di Cisanello Azienda Ospedaliero Universitaria
Pisa, Tuscany, Italy
Recruiting
AO Universitaria Policlinico Vittorio Emanuele
Catania, Italy
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy
Recruiting
AORN dei Colli
Naples, Italy
Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G Pascale
Naples, Italy
Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Recruiting
Azienda Sanitaria Locale (ASL) Taranto
Taranto, Italy
Recruiting
Hospital Universitario Virgen De La Victoria Malaga
Málaga, Andalusia, Spain
Recruiting
Parc Tauli Sabadell Hospital Universitari
Sabadell, Barcelona, Spain
Recruiting
Hospital Universitario De Jerez
Jerez de la Frontera, Cadiz, Spain
Recruiting
Consorcio Hospitalario Provincial de Castellon
Castellon, Castellon, Spain
Recruiting
Complejo Hospitalario Universitario de Ferrol - Hospital Naval
Ferrol, Galicia, Spain
Recruiting
Hospital Universitario Alvaro Cunqueiro
Vigo, Galicia, Spain
Recruiting
Hospital Torrecardenas
Almería, Spain
Recruiting
University Hospital of Jaen
Jaén, Spain
Recruiting
Hospital Arnau de Vilanova
Lleida, Spain
Recruiting
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Spain
Recruiting
Hospital Universitari Sant Joan de Reus
Tarragona, Spain
Recruiting
Showing 49 of 49 sites. 44 of the 49 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05363319. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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