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NCT05363319From ClinicalTrials.govRecruiting

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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An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced | Trialion