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)
July 23, 2026 updated by: Regeneron Pharmaceuticals
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)
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023.
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.
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Administrator
- Phone Number: 844-734-6643
- Email: clinicaltrials@regeneron.com
Study Locations
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Salzburg, Austria, 5020
- Recruiting
- Salzburger Landeskliniken (SALK)
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Carinthia
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Klagenfurt, Carinthia, Austria, 9020
- Recruiting
- Klinikum Klagenfurt
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Angers, France, 49000
- Recruiting
- Centre Hospitalier Universitaire Angers
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Clermont-Ferrand, France, 63003
- Completed
- Center Hospitalier Universitaire (CHU) of Clermont
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Le Mans, France, 72037
- Recruiting
- Centre Hospitalier - Le Mans
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Paris, France, 75020
- Recruiting
- Hôpital Tenon
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Alsace
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Mulhouse, Alsace, France, 68100
- Recruiting
- Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
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Bas-Rhin
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Strasbourg, Bas-Rhin, France, 67000
- Recruiting
- Hopitaux Universitaires de Strasbourg
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, France, 13915
- Recruiting
- APHM - Hôpital Nord
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Vaucluse
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Avignon, Vaucluse, France, 84918
- Recruiting
- Sainte Catherine Institut du Cancer Avignon Provence
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Vienne
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Poitiers, Vienne, France, 86021
- Recruiting
- Centre Hospitalier Universitaire (CHU) de Poitiers
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Berlin, Germany, 14089
- Recruiting
- Gemeinschaftskrankenhaus Havelhoehe
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Dortmund, Germany, 44263
- Recruiting
- Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
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Halle, Germany, 06120
- Recruiting
- Krankenhaus Martha-Maria Halle-Doelau gGmbH
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Mainz, Germany, 55131
- Withdrawn
- Marienhaus Klinikum Mainz
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Baden-Wurttemberg
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Konstanz, Baden-Wurttemberg, Germany, 78464
- Recruiting
- Klinikum Konstanz
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Weinsberg, Baden-Wurttemberg, Germany, 74189
- Withdrawn
- MedFISMO
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Bavaria
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München, Bavaria, Germany, 81925
- Recruiting
- Staedtisches Klinikum Muenchen Bogenhausen
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Nuremberg, Bavaria, Germany, 90419
- Completed
- Nuremberg Hospital, Campus North
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Georgsmarienhuette
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Georgsmarienhütte, Georgsmarienhuette, Germany, 49124
- Recruiting
- Franziskus Hospital Harderberg
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Lower Saxony
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Rotenburg (Wümme), Lower Saxony, Germany, 27356
- Recruiting
- Agaplesion Diakonieklinikum Rotenburg
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Germany, 48145
- Recruiting
- St. Franziskus Hospital Münster
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Troisdorf, North Rhine-Westphalia, Germany, 53840
- Recruiting
- Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
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Saxony
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Chemnitz, Saxony, Germany, 09116
- Withdrawn
- Klinikum Chemnitz gGmbH
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Leipzig, Saxony, Germany, 4347
- Recruiting
- Pneumologische Praxis PD Dr. Med Christian Gessner
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Catania, Italy, 95123
- Recruiting
- AO Universitaria Policlinico Vittorio Emanuele
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Milan, Italy, 20133
- Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Modena, Italy, 41124
- Recruiting
- Azienda Ospedaliero-Universitaria di Modena
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Naples, Italy, 80131
- Recruiting
- AORN dei Colli
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Naples, Italy, 80131
- Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione G Pascale
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Pavia, Italy, 27100
- Recruiting
- Fondazione IRCCS Policlinico San Matteo
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Taranto, Italy, 74010
- Recruiting
- Azienda Sanitaria Locale (ASL) Taranto
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Udine, Italy, 33100
- Recruiting
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
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Catania
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Misterbianco, Catania, Italy, 95065
- Recruiting
- Humanitas Istituto Clinico Catanese
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Firenze
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Florence, Firenze, Italy, 50134
- Recruiting
- Aou Careggi
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Milan
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Rozzano, Milan, Italy, 20089
- Recruiting
- Irccs Humanitas Research Hospital
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Piedmont
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Orbassano, Piedmont, Italy, 10043
- Recruiting
- San Luigi Gonzaga University Hospital
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Tuscany
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Pisa, Tuscany, Italy, 56126
- Recruiting
- Ospedale Di Cisanello Azienda Ospedaliero Universitaria
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Almería, Spain, 04009
- Recruiting
- Hospital Torrecardenas
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Jaén, Spain, 23007
- Recruiting
- University Hospital of Jaen
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Lleida, Spain, 25198
- Recruiting
- Hospital Arnau de Vilanova
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Santa Cruz de Tenerife, Spain, 38010
- Recruiting
- Hospital Universitario Nuestra Señora de Candelaria
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Tarragona, Spain, 43204
- Recruiting
- Hospital Universitari Sant Joan de Reus
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Andalusia
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Málaga, Andalusia, Spain, 29010
- Recruiting
- Hospital Universitario Virgen De La Victoria Malaga
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Barcelona
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Sabadell, Barcelona, Spain, 08208
- Recruiting
- Parc Tauli Sabadell Hospital Universitari
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Cadiz
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Jerez de la Frontera, Cadiz, Spain, 11407
- Recruiting
- Hospital Universitario de Jerez
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Castellon
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Castellon, Castellon, Spain, 12002
- Recruiting
- Consorcio Hospitalario Provincial de Castellón
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Galicia
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Ferrol, Galicia, Spain, 15405
- Recruiting
- Complejo Hospitalario Universitario de Ferrol - Hospital Naval
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Vigo, Galicia, Spain, 36204
- Recruiting
- Hospital Universitario Álvaro Cunqueiro
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
Description
Key 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Cohort 1
Cemiplimab monotherapy
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solution for injection via intravenous (IV) infusion
Other Names:
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Cohort 2
Cemiplimab in combination with platinum-based chemotherapy
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solution for injection via intravenous (IV) infusion
Other Names:
IV administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall survival (OS)
Time Frame: Up to 72 months
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Date and primary cause of death
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Up to 72 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Response Rate (ORR)
Time Frame: Up to 72 months
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Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response.
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Up to 72 months
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Duration of Response (DoR)
Time Frame: Up to 72 months
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Defined among responders (patients with a complete response or partial response) as the time from the date of the first response after cemiplimab treatment initiation until the first date of disease progression or death due to any cause.
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Up to 72 months
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Time to Response (TTR)
Time Frame: Up to 72 months
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Defined as the time from the first cemiplimab dose until the date of first response observed for that patient.
Patients who die during the study will be censored using the date of the last valid disease assessment).
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Up to 72 months
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Progression-Free Survival (PFS)
Time Frame: Up to 72 months
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Defined as the time from the first dose of cemiplimab until the date of the first documented tumour progression or death due to any cause.
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Up to 72 months
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Time to first subsequent anti-NSCLC treatment (TTST)
Time Frame: Up to 72 months
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Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment.
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Up to 72 months
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Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Time Frame: Up to 72 months
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Number of patients with treatment related adverse events occurring during treatment
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Up to 72 months
|
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Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Time Frame: Up to 72 months
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Number of patients with serious treatment related adverse events occurring during treatment
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Up to 72 months
|
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Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Time Frame: Up to 72 months
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Number of patients with immune-mediated adverse events and serious immune-mediated adverse events occurring during treatment
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Up to 72 months
|
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Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Time Frame: Up to 72 months
|
Number of patients with infusion related reactions and serious infusion related reactions adverse events occurring during treatment
|
Up to 72 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2022
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
October 30, 2028
Study Registration Dates
First Submitted
May 2, 2022
First Submitted That Met QC Criteria
May 2, 2022
First Posted (Actual)
May 5, 2022
Study Record Updates
Last Update Posted (Actual)
July 24, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R2810-ONC-2325
- U1111-1275-9867 (Registry Identifier: ICTRP)
Plan for Individual participant data (IPD)
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.