RecruitingNCT05363319

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)


Sponsor

Regeneron Pharmaceuticals

Enrollment

500 participants

Start Date

Oct 26, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria5

  • 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

Interventions

DRUGCemiplimab

solution for injection via intravenous (IV) infusion

DRUGPlatinum-based chemotherapy

IV administration


Locations(49)

Klinikum Klagenfurt

Klagenfurt, Carinthia, Austria

Salzburger Landeskliniken (SALK)

Salzburg, Austria

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

Mulhouse, Alsace, France

APHM - Hopital Nord

Marseille, Bouches-du-Rhône, France

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, Nouvelle-Aquitaine, France

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, Vaucluse, France

Centre Hospitalier Universitaire Angers

Angers, France

Center Hospitalier Universitaire (CHU) of Clermont

Clermont-Ferrand, France

Centre Hospitalier - Le mans

Le Mans, France

Hopital Tenon

Paris, France

Hopitaux Universitaires de Strasbourg

Strasbourg, France

Klinikum Konstanz

Konstanz, Baden-Wurttemberg, Germany

MedFISMO

Weinsberg, Baden-Wurttemberg, Germany

Staedtisches Klinikum Muenchen Bogenhausen

München, Bavaria, Germany

Franziskus Hospital Harderberg

Georgsmarienhütte, Georgsmarienhuette, Germany

Agaplesion Diakonieklinikum Rotenburg

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

St. Franziskus Hospital Münster

Münster, North Rhine-Westphalia, Germany

Haematologisch Onkologische Schwerpunktpraxis - Troisdorf

Troisdorf, North Rhine-Westphalia, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany

Gemeinschaftskrankenhaus Havelhoehe

Berlin, Germany

Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)

Dortmund, Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, Germany

Pneumologische Praxis PD Dr. Med Christian Gessner

Leipzig, Germany

Marienhaus Klinikum Mainz

Mainz, Germany

Nuremberg Hospital, Campus North

Nuremberg, Germany

Humanitas Istituto Clinico Catanese

Misterbianco, Catania, Italy

AOU Careggi

Florence, Firenze, Italy

IRCCS Humanitas Research Hospital

Rozzano, Milan, Italy

San Luigi Gonzaga University Hospital

Orbassano, Piedmont, Italy

Ospedale Di Cisanello Azienda Ospedaliero Universitaria

Pisa, Tuscany, Italy

AO Universitaria Policlinico Vittorio Emanuele

Catania, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

AORN dei Colli

Napoli, Italy

Istituto Nazionale Tumori IRCCS Fondazione G Pascale

Napoli, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Azienda Sanitaria Locale (ASL) Taranto

Taranto, Italy

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

Udine, Italy

Hospital Universitario Virgen De La Victoria Malaga

Málaga, Andalusia, Spain

Parc Tauli Sabadell Hospital Universitari

Sabadell, Barcelona, Spain

Hospital Universitario De Jerez

Jerez de la Frontera, Cadiz, Spain

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellon, Spain

Complejo Hospitalario Universitario de Ferrol - Hospital Naval

Ferrol, Galicia, Spain

Hospital Universitario Alvaro Cunqueiro

Vigo, Galicia, Spain

Hospital Torrecardenas

Almería, Spain

University Hospital of Jaen

Jaén, Spain

Hospital Arnau de Vilanova

Lleida, Spain

Hospital Universitario Nuestra Senora de Candelaria

Santa Cruz de Tenerife, Spain

Hospital Universitari Sant Joan de Reus

Tarragona, Spain

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NCT05363319


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