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
CEMI-LUNG
2 other identifiers
observational
500
5 countries
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 5, 2022
CompletedStudy Start
First participant enrolled
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2028
April 22, 2026
April 1, 2026
6 years
May 2, 2022
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Date and primary cause of death
Up to 72 months
Secondary Outcomes (9)
Overall Response Rate (ORR)
Up to 72 months
Duration of Response (DoR)
Up to 72 months
Time to Response (TTR)
Up to 72 months
Progression-Free Survival (PFS)
Up to 72 months
Time to first subsequent anti-NSCLC treatment (TTST)
Up to 72 months
- +4 more secondary outcomes
Study Arms (2)
Cohort 1
Cemiplimab monotherapy
Cohort 2
Cemiplimab in combination with platinum-based chemotherapy
Interventions
solution for injection via intravenous (IV) infusion
Eligibility Criteria
The source population for this study will be patients with either locally advanced NSCLC not suitable for definitive chemoradiation or metastatic NSCLC and who are initiating a cemiplimab-based regimen of treatment as part of routine clinical practice at the time of study enrollment. The study will aim to enroll approximately 500 adult patients from up to 50 sites across Europe.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Klinikum Klagenfurt
Klagenfurt, Carinthia, 9020, Austria
Salzburger Landeskliniken (SALK)
Salzburg, 5020, Austria
Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
Mulhouse, Alsace, 68100, France
APHM - Hopital Nord
Marseille, Bouches-du-Rhône, 13915, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, New Aquitaine, 86021, France
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, Vaucluse, 84918, France
Centre Hospitalier Universitaire Angers
Angers, 49000, France
Center Hospitalier Universitaire (CHU) of Clermont
Clermont-Ferrand, 63003, France
Centre Hospitalier - Le mans
Le Mans, 72037, France
Hopital Tenon
Paris, 75020, France
Hopitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Klinikum Konstanz
Konstanz, Baden-Wurttemberg, 78464, Germany
MedFISMO
Weinsberg, Baden-Wurttemberg, 74189, Germany
Staedtisches Klinikum Muenchen Bogenhausen
München, Bavaria, 81925, Germany
Franziskus Hospital Harderberg
Georgsmarienhütte, Georgsmarienhuette, 49124, Germany
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme), Lower Saxony, 27356, Germany
St. Franziskus Hospital Münster
Münster, North Rhine-Westphalia, 48145, Germany
Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
Troisdorf, North Rhine-Westphalia, 53840, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 09116, Germany
Pneumologische Praxis PD Dr. Med Christian Gessner
Leipzig, Saxony, 4347, Germany
Gemeinschaftskrankenhaus Havelhoehe
Berlin, 14089, Germany
Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
Dortmund, 44263, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120, Germany
Marienhaus Klinikum Mainz
Mainz, 55131, Germany
Nuremberg Hospital, Campus North
Nuremberg, 90419, Germany
Humanitas Istituto Clinico Catanese
Misterbianco, Catania, 95065, Italy
AOU Careggi
Florence, Firenze, 50134, Italy
IRCCS Humanitas Research Hospital
Rozzano, Milan, 20089, Italy
San Luigi Gonzaga University Hospital
Orbassano, Piedmont, 10043, Italy
Ospedale Di Cisanello Azienda Ospedaliero Universitaria
Pisa, Tuscany, 56126, Italy
AO Universitaria Policlinico Vittorio Emanuele
Catania, 95123, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, 41124, Italy
AORN dei Colli
Naples, 80131, Italy
Istituto Nazionale Tumori IRCCS Fondazione G Pascale
Naples, 80131, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Sanitaria Locale (ASL) Taranto
Taranto, 74010, Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
Udine, 33100, Italy
Hospital Universitario Virgen De La Victoria Malaga
Málaga, Andalusia, 29010, Spain
Parc Tauli Sabadell Hospital Universitari
Sabadell, Barcelona, 08208, Spain
Hospital Universitario De Jerez
Jerez de la Frontera, Cadiz, 11407, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, Castellon, 12002, Spain
Complejo Hospitalario Universitario de Ferrol - Hospital Naval
Ferrol, Galicia, 15405, Spain
Hospital Universitario Alvaro Cunqueiro
Vigo, Galicia, 36204, Spain
Hospital Torrecardenas
Almería, 04009, Spain
University Hospital of Jaen
Jaén, 23005, Spain
Hospital Arnau de Vilanova
Lleida, 25198, Spain
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital Universitari Sant Joan de Reus
Tarragona, 43204, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 5, 2022
Study Start
October 26, 2022
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
October 30, 2028
Last Updated
April 22, 2026
Record last verified: 2026-04