NCT05363319Active, not recruiting
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 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 509 (actual)
- First submitted
- 2 May 2022
- Start date
- 26 Oct 2022
- Primary completion date
- 3 Oct 2028
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT05363319
What you commit to
- Study type: Observational
- Participants enrolled: 509
- From 26 Oct 2022 to the primary completion date, 3 Oct 2028
- 46 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received cemiplimab prior to enrollment
- Is concurrently participating in any other study of an investigational drug or procedure
Other illness
- Has uncontrolled autoimmune disease
- 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
Other
- Has a contraindication to cemiplimab as noted in the local SmPC
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikum Klagenfurt Coordinator of this site? Confirm its status | Klagenfurt | Austria | Unknown status |
| Salzburger Landeskliniken (SALK) Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Gemeinschaftskrankenhaus Havelhoehe Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos) Coordinator of this site? Confirm its status | Dortmund | Germany | Unknown status |
| Franziskus Hospital Harderberg Coordinator of this site? Confirm its status | Georgsmarienhütte | Germany | Unknown status |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Klinikum Konstanz Coordinator of this site? Confirm its status | Konstanz | Germany | Unknown status |
| Pneumologische Praxis PD Dr. Med Christian Gessner Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Staedtisches Klinikum Muenchen Bogenhausen Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| St. Franziskus Hospital Münster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Nuremberg Hospital, Campus North Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Agaplesion Diakonieklinikum Rotenburg Coordinator of this site? Confirm its status | Rotenburg (Wümme) | Germany | Unknown status |
| Haematologisch Onkologische Schwerpunktpraxis - Troisdorf Coordinator of this site? Confirm its status | Troisdorf | Germany | Unknown status |
| Hospital Torrecardenas Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
| Consorcio Hospitalario Provincial de Castellon Coordinator of this site? Confirm its status | Castellon | Spain | Unknown status |
| Complejo Hospitalario Universitario de Ferrol - Hospital Naval Coordinator of this site? Confirm its status | Ferrol | Spain | Unknown status |
| University Hospital of Jaen Coordinator of this site? Confirm its status | Jaén | Spain | Unknown status |
| Hospital Universitario De Jerez Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
| Hospital Arnau de Vilanova Coordinator of this site? Confirm its status | Lleida | Spain | Unknown status |
| Hospital Universitario Virgen De La Victoria Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Parc Tauli Sabadell Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Hospital Universitario Nuestra Señora de Candelaria Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Hospital Universitari Sant Joan de Reus Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
| Hospital Universitario Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Centre Hospitalier Universitaire Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Sainte Catherine Institut du Cancer Avignon Provence Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| Center Hospitalier Universitaire (CHU) of Clermont Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| APHM - Hopital Nord Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital Coordinator of this site? Confirm its status | Mulhouse | France | Unknown status |
| Hôpital Tenon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Universitaire (CHU) de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| AO Universitaria Policlinico Vittorio Emanuele Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| AOU Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Humanitas Istituto Clinico Catanese Coordinator of this site? Confirm its status | Misterbianco | Italy | Unknown status |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| AORN dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| San Luigi Gonzaga University Hospital Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Ospedale Di Cisanello Azienda Ospedaliero Universitaria Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| IRCCS Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| Azienda Sanitaria Locale (ASL) Taranto Coordinator of this site? Confirm its status | Taranto | Italy | Unknown status |
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.