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Clinical Trials in Germany / NCT05363319
Recruiting Observational

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

NCT05363319 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2022-10-26
Last updated
2026-09-24

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Cemiplimab →Platinum-based chemotherapy

Cemiplimab: solution for injection via intravenous (IV) infusion

Platinum-based chemotherapy: IV administration

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Klinikum Klagenfurt Klagenfurt Carinthia Recruiting
Salzburger Landeskliniken (SALK) Salzburg Austria Recruiting
Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital Mulhouse Alsace Recruiting
Hopitaux Universitaires de Strasbourg Strasbourg Bas-Rhin Recruiting
APHM - Hopital Nord Marseille Bouches-du-Rhône Recruiting
Sainte Catherine Institut du Cancer Avignon Provence Avignon Vaucluse Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers Poitiers Vienne 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 Recruiting
MedFISMO Weinsberg Baden-Wurttemberg Withdrawn
Staedtisches Klinikum Muenchen Bogenhausen München Bavaria Recruiting
Nuremberg Hospital, Campus North Nuremberg Bavaria Completed
Franziskus Hospital Harderberg Georgsmarienhütte Georgsmarienhuette Recruiting
Agaplesion Diakonieklinikum Rotenburg Rotenburg (Wümme) Lower Saxony Recruiting
St. Franziskus Hospital Münster Münster North Rhine-Westphalia Recruiting
Haematologisch Onkologische Schwerpunktpraxis - Troisdorf Troisdorf North Rhine-Westphalia Recruiting
Klinikum Chemnitz gGmbH Chemnitz Saxony Withdrawn
Pneumologische Praxis PD Dr. Med Christian Gessner Leipzig Saxony 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 Recruiting
AOU Careggi Florence Firenze Recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia Udine Friuli Venezia Giulia Recruiting
IRCCS Humanitas Research Hospital Rozzano Milan Recruiting
San Luigi Gonzaga University Hospital Orbassano Piedmont Recruiting
Ospedale Di Cisanello Azienda Ospedaliero Universitaria Pisa Tuscany 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 Recruiting
Parc Tauli Sabadell Hospital Universitari Sabadell Barcelona Recruiting

+ 9 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

More Regeneron Pharmaceuticals trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05363319 on ClinicalTrials.gov ↗ ← All trials in Germany