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

Last updated: March 17, 2026
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Treatment

Platinum-based chemotherapy

Cemiplimab

Clinical Study ID

NCT05363319
R2810-ONC-2325
U1111-1275-9867
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ornon-squamous NSCLC

  3. Prescribed a cemiplimab-based regimen as part of routine clinical practice asdetermined by the treating physician per standard of care and in accordance with theSummary 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 studyand have signed informed consent prior to any study activities

Exclusion

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 orprocedure

  5. Has cognitive impairment or other medical condition that, in the opinion of theinvestigator, would interfere with the ability to complete the study-relatedquestionnaires

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Platinum-based chemotherapy
Phase:
Study Start date:
October 26, 2022
Estimated Completion Date:
October 30, 2028

Study 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.

Connect with a study center

  • Klinikum Klagenfurt

    Klagenfurt, Carinthia 9020
    Austria

    Active - Recruiting

  • Klinikum Klagenfurt

    Klagenfurt 2774326, Carinthia 2774686 9020
    Austria

    Site Not Available

  • Investigational Site Number: 1-11CBS6QG

    Grimmenstein, Niederösterreich 2840
    Austria

    Site Not Available

  • Salzburger Landeskliniken (SALK)

    Salzburg 2766824, Salzburg 2766823 5020
    Austria

    Site Not Available

  • Investigational Site Number: 040-001

    Klagenfurt, 9020
    Austria

    Site Not Available

  • Investigational Site Number: 040-001

    Klagenfurth Am Wörthersee, 9020
    Austria

    Site Not Available

  • Investigational Site Number: 040-004

    Salzburg, 5020
    Austria

    Site Not Available

  • Salzburger Landeskliniken (SALK)

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital

    Mulhouse, Alsace 68100
    France

    Active - Recruiting

  • Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital

    Mulhouse 2991214, Alsace 68100
    France

    Site Not Available

  • Investigational Site Number: 250-001

    Strasbourg, Bas-Rhin 67000
    France

    Site Not Available

  • APHM - Hopital Nord

    Marseille, Bouches-du-Rhône 13915
    France

    Active - Recruiting

  • Investigational Site Number: 250-004

    Marseille, Bouches-du-Rhône 13015
    France

    Site Not Available

  • Investigational Site Number: 250-007

    Mulhouse, Haut-Rhin 68100
    France

    Site Not Available

  • Investigational Site Number: 250-003

    Angers, Maine-et-Loire 49933
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, Nouvelle-Aquitaine 86021
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers 2986495, Nouvelle-Aquitaine 11071620 86021
    France

    Site Not Available

  • APHM - Hopital Nord

    Marseille 2995469, Provenza 13015
    France

    Site Not Available

  • Investigational Site Number: 250-005

    Clermont-Ferrand, Puy-de-Dôme 63000
    France

    Site Not Available

  • Investigational Site Number: 1-YGJYO79

    Le Mans, Sarthe 72037
    France

    Active - Recruiting

  • Investigational Site Number: 250-008

    Le Mans, Sarthe 72037
    France

    Site Not Available

  • Hopitaux Universitaires de Strasbourg

    Strasbourg 2973783, Strasbourg 67091
    France

    Site Not Available

  • Investigational Site Number: 1-11FMS11M

    Avignon, Vaucluse 84000
    France

    Active - Recruiting

  • Investigational Site Number: 250-009

    Avignon, Vaucluse 84000
    France

    Site Not Available

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, Vaucluse 84918
    France

    Active - Recruiting

  • Investigational Site Number: 1-11F4O2VV

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • Investigational Site Number: 250-006

    Poitiers, Vienne 86021
    France

    Site Not Available

  • Centre Hospitalier Universitaire Angers

    Angers, 49000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Angers

    Angers 3037656, 49933
    France

    Site Not Available

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon 3035681, 84918
    France

    Site Not Available

  • Center Hospitalier Universitaire (CHU) of Clermont

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • Center Hospitalier Universitaire (CHU) of Clermont

    Clermont-Ferrand 3024635, 63003
    France

    Site Not Available

  • Centre Hospitalier - Le mans

    Le Mans, 72037
    France

    Active - Recruiting

  • Centre Hospitalier - Le mans

    Le Mans 3003603, 72037
    France

    Site Not Available

  • Hopital Tenon

    Paris, 75020
    France

    Active - Recruiting

  • Investigational Site Number: 250-002

    Paris, 75970
    France

    Site Not Available

  • Hopital Tenon

    Paris 2988507, 75020
    France

    Site Not Available

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67091
    France

    Active - Recruiting

  • Klinikum Konstanz

    Konstanz, Baden-Wurttemberg 78464
    Germany

    Active - Recruiting

  • MedFISMO

    Weinsberg, Baden-Wurttemberg 74189
    Germany

    Site Not Available

  • Klinikum Konstanz

    Konstanz 2885679, Baden-Wurttemberg 2953481 78464
    Germany

    Site Not Available

  • MedFISMO

    Weinsberg 2812158, Baden-Wurttemberg 2953481 74189
    Germany

    Site Not Available

  • Investigational Site Number: 276-005

    Konstanz, Baden-Württemberg 78464
    Germany

    Site Not Available

  • Investigational Site Number: 276-002

    Weinsberg, Baden-Württemberg 74189
    Germany

    Site Not Available

  • Staedtisches Klinikum Muenchen Bogenhausen

    München, Bavaria 81925
    Germany

    Active - Recruiting

  • Staedtisches Klinikum Muenchen Bogenhausen

    München 2867713, Bavaria 2951839 81925
    Germany

    Site Not Available

  • Investigational Site Number: 276-013

    München, Bayern 81925
    Germany

    Site Not Available

  • Investigational Site Number: 276-006

    Nürnberg, Bayern 90419
    Germany

    Site Not Available

  • Franziskus Hospital Harderberg

    Georgsmarienhütte, Georgsmarienhuette 49124
    Germany

    Active - Recruiting

  • Franziskus Hospital Harderberg

    Georgsmarienhütte 2921242, Georgsmarienhuette 49124
    Germany

    Site Not Available

  • Agaplesion Diakonieklinikum Rotenburg

    Rotenburg (Wümme), Großhansdorf, Schleswig-Holstein 22927
    Germany

    Active - Recruiting

  • Agaplesion Diakonieklinikum Rotenburg

    Rotenburg (Wümme) 2844437, Großhansdorf, Schleswig-Holstein 22927
    Germany

    Site Not Available

  • Investigational Site Number: 276-012

    Georgsmarienhütte, Niedersachsen 49124
    Germany

    Site Not Available

  • Investigational Site Number: 276-015

    Dortmund, Nordrhein-Westfalen 44263
    Germany

    Site Not Available

  • Investigational Site Number: 276-009

    Troisdorf, Nordrhein-Westfalen 53840
    Germany

    Site Not Available

  • St. Franziskus Hospital Münster

    Münster, North Rhine-Westphalia 48145
    Germany

    Active - Recruiting

  • Haematologisch Onkologische Schwerpunktpraxis - Troisdorf

    Troisdorf, North Rhine-Westphalia 53840
    Germany

    Active - Recruiting

  • St. Franziskus Hospital Münster

    Münster 2867543, North Rhine-Westphalia 2861876 48145
    Germany

    Site Not Available

  • Haematologisch Onkologische Schwerpunktpraxis - Troisdorf

    Troisdorf 2821029, North Rhine-Westphalia 2861876 53840
    Germany

    Site Not Available

  • Investigational Site Number: 276-019

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Marienhaus Klinikum Mainz

    Mainz 2874225, Rhineland-Palatinate 2847618 55131
    Germany

    Site Not Available

  • Investigational Site Number: 276-010

    Chemnitz, Sachsen 09116
    Germany

    Site Not Available

  • Investigational Site Number: 276-001

    Leipzig, Sachsen 04357
    Germany

    Site Not Available

  • Investigational Site Number: 276-016

    Halle, Sachsen-Anhalt 6120
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony 09116
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz 2940132, Saxony 2842566 09116
    Germany

    Site Not Available

  • Gemeinschaftskrankenhaus Havelhoehe

    Berlin, 14089
    Germany

    Active - Recruiting

  • Investigational Site Number: 276-003

    Berlin, 14089
    Germany

    Site Not Available

  • Gemeinschaftskrankenhaus Havelhoehe

    Berlin 2950159, 14089
    Germany

    Site Not Available

  • Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)

    Dortmund, 44263
    Germany

    Active - Recruiting

  • Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)

    Dortmund 2935517, 44263
    Germany

    Site Not Available

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120
    Germany

    Active - Recruiting

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle 2911522, 06120
    Germany

    Site Not Available

  • Pneumologische Praxis PD Dr. Med Christian Gessner

    Leipzig, 04357
    Germany

    Active - Recruiting

  • Pneumologische Praxis PD Dr. Med Christian Gessner

    Leipzig 2879139, 04357
    Germany

    Site Not Available

  • Marienhaus Klinikum Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Nuremberg Hospital, Campus North

    Nuremberg, 90419
    Germany

    Active - Recruiting

  • Nuremberg Hospital, Campus North

    Nuremberg 2861650, 90419
    Germany

    Site Not Available

  • AO Universitaria Policlinico Vittorio Emanuele

    Catania 2525068, Catania 95123
    Italy

    Site Not Available

  • Humanitas Istituto Clinico Catanese

    Misterbianco, Catania 95065
    Italy

    Active - Recruiting

  • Humanitas Istituto Clinico Catanese

    Misterbianco 2524123, Catania 95065
    Italy

    Site Not Available

  • AOU Careggi

    Florence, Firenze 50134
    Italy

    Active - Recruiting

  • AOU Careggi

    Florence 3176959, Firenze 50134
    Italy

    Site Not Available

  • IRCCS Humanitas Research Hospital

    Rozzano, Milan 20089
    Italy

    Active - Recruiting

  • IRCCS Humanitas Research Hospital

    Rozzano 3168837, Milan 20089
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena

    Modena 3173331, Modena 41124
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia 3171366, Pavia 27100
    Italy

    Site Not Available

  • San Luigi Gonzaga University Hospital

    Orbassano, Piedmont 10043
    Italy

    Active - Recruiting

  • San Luigi Gonzaga University Hospital

    Orbassano 3171986, Piedmont 3170831 10043
    Italy

    Site Not Available

  • Azienda Sanitaria Locale (ASL) Taranto

    Taranto 3165926, Taranto 74010
    Italy

    Site Not Available

  • Ospedale Di Cisanello Azienda Ospedaliero Universitaria

    Pisa, Tuscany 56126
    Italy

    Active - Recruiting

  • Ospedale Di Cisanello Azienda Ospedaliero Universitaria

    Pisa 3170647, Tuscany 3165361 56126
    Italy

    Site Not Available

  • AO Universitaria Policlinico Vittorio Emanuele

    Catania, 95123
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan 6951411, 20133
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41124
    Italy

    Active - Recruiting

  • AORN dei Colli

    Napoli, 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione G Pascale

    Napoli, 80131
    Italy

    Active - Recruiting

  • AORN dei Colli

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione G Pascale

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

  • Azienda Sanitaria Locale (ASL) Taranto

    Taranto, 74010
    Italy

    Active - Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia

    Udine, 33100
    Italy

    Active - Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia

    Udine 3165072, 33100
    Italy

    Site Not Available

  • Hospital Torrecardenas

    Almería 2521886, Almería 04009
    Spain

    Site Not Available

  • Investigational Site Number: 724-008

    Malaga, Andalucia 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen De La Victoria Malaga

    Málaga, Andalusia 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen De La Victoria Malaga

    Málaga 2514256, Andalusia 2593109 29010
    Spain

    Site Not Available

  • Parc Tauli Sabadell Hospital Universitari

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Parc Tauli Sabadell Hospital Universitari

    Sabadell 3111199, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario De Jerez

    Jerez de la Frontera, Cadiz 11407
    Spain

    Active - Recruiting

  • Investigational Site Number: 724-001

    Jerez de la Frontera, Cadiz 11407
    Spain

    Site Not Available

  • Hospital Universitario De Jerez

    Jerez de la Frontera 2516326, Cadiz 11407
    Spain

    Site Not Available

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Castellon 12002
    Spain

    Active - Recruiting

  • Consorcio Hospitalario Provincial de Castellon

    Castellon 2519752, Castellon 12002
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Ferrol - Hospital Naval

    Ferrol, Galicia 15405
    Spain

    Active - Recruiting

  • Hospital Universitario Alvaro Cunqueiro

    Vigo, Galicia 36204
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Ferrol - Hospital Naval

    Ferrol 3123493, Galicia 3336902 15405
    Spain

    Site Not Available

  • Hospital Universitario Alvaro Cunqueiro

    Vigo 3105976, Pontevedra 36213
    Spain

    Site Not Available

  • Hospital Torrecardenas

    Almería, 04009
    Spain

    Active - Recruiting

  • University Hospital of Jaen

    Jaén, 23005
    Spain

    Active - Recruiting

  • University Hospital of Jaen

    Jaén 2516395, 23005
    Spain

    Site Not Available

  • Hospital Arnau de Vilanova

    Lleida, 25198
    Spain

    Active - Recruiting

  • Investigational Site Number: 724-002

    Lleida, 25198
    Spain

    Site Not Available

  • Hospital Arnau de Vilanova

    Lleida 3118514, 25198
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Senora de Candelaria

    Santa Cruz de Tenerife, 38010
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Senora de Candelaria

    Santa Cruz de Tenerife 2511174, 38010
    Spain

    Site Not Available

  • Hospital Universitari Sant Joan de Reus

    Tarragona, 43204
    Spain

    Active - Recruiting

  • Hospital Universitari Sant Joan de Reus

    Tarragona 3108288, 43204
    Spain

    Site Not Available

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