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NCT05363319Active, not recruiting

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 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
509 (actual)
First submitted
2 May 2022
Start date
26 Oct 2022
Primary completion date
3 Oct 2028
Lead sponsor
Regeneron Pharmaceuticals
Diseases
Lung cancer
NCT number
NCT05363319

What you commit to

  • Study type: Observational
  • Participants enrolled: 509
  • From 26 Oct 2022 to the primary completion date, 3 Oct 2028
  • 46 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received cemiplimab prior to enrollment
  • Is concurrently participating in any other study of an investigational drug or procedure

Other illness

  • Has uncontrolled autoimmune disease
  • 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

Other

  • Has a contraindication to cemiplimab as noted in the local SmPC

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Klinikum Klagenfurt
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KlagenfurtAustriaUnknown status
Salzburger Landeskliniken (SALK)
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SalzburgAustriaUnknown status
Gemeinschaftskrankenhaus Havelhoehe
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BerlinGermanyUnknown status
Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
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DortmundGermanyUnknown status
Franziskus Hospital Harderberg
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GeorgsmarienhütteGermanyUnknown status
Krankenhaus Martha-Maria Halle-Doelau gGmbH
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HalleGermanyUnknown status
Klinikum Konstanz
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KonstanzGermanyUnknown status
Pneumologische Praxis PD Dr. Med Christian Gessner
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LeipzigGermanyUnknown status
Staedtisches Klinikum Muenchen Bogenhausen
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MünchenGermanyUnknown status
St. Franziskus Hospital Münster
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MünsterGermanyUnknown status
Nuremberg Hospital, Campus North
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NurembergGermanyUnknown status
Agaplesion Diakonieklinikum Rotenburg
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Rotenburg (Wümme)GermanyUnknown status
Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
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TroisdorfGermanyUnknown status
Hospital Torrecardenas
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AlmeríaSpainUnknown status
Consorcio Hospitalario Provincial de Castellon
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CastellonSpainUnknown status
Complejo Hospitalario Universitario de Ferrol - Hospital Naval
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FerrolSpainUnknown status
University Hospital of Jaen
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JaénSpainUnknown status
Hospital Universitario De Jerez
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Jerez de la FronteraSpainUnknown status
Hospital Arnau de Vilanova
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LleidaSpainUnknown status
Hospital Universitario Virgen De La Victoria Malaga
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MálagaSpainUnknown status
Parc Tauli Sabadell Hospital Universitari
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SabadellSpainUnknown status
Hospital Universitario Nuestra Señora de Candelaria
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Santa Cruz de TenerifeSpainUnknown status
Hospital Universitari Sant Joan de Reus
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TarragonaSpainUnknown status
Hospital Universitario Alvaro Cunqueiro
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VigoSpainUnknown status
Centre Hospitalier Universitaire Angers
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AngersFranceUnknown status
Sainte Catherine Institut du Cancer Avignon Provence
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AvignonFranceUnknown status
Center Hospitalier Universitaire (CHU) of Clermont
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Clermont-FerrandFranceUnknown status
Centre Hospitalier Le Mans
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Le MansFranceUnknown status
APHM - Hopital Nord
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MarseilleFranceUnknown status
Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
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MulhouseFranceUnknown status
Hôpital Tenon
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ParisFranceUnknown status
Centre Hospitalier Universitaire (CHU) de Poitiers
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PoitiersFranceUnknown status
Hopitaux Universitaires de Strasbourg
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StrasbourgFranceUnknown status
AO Universitaria Policlinico Vittorio Emanuele
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CataniaItalyUnknown status
AOU Careggi
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FlorenceItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyUnknown status
Humanitas Istituto Clinico Catanese
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MisterbiancoItalyUnknown status
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyUnknown status
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
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NaplesItalyUnknown status
AORN dei Colli
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NaplesItalyUnknown status
San Luigi Gonzaga University Hospital
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OrbassanoItalyUnknown status
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown status
Ospedale Di Cisanello Azienda Ospedaliero Universitaria
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PisaItalyUnknown status
IRCCS Humanitas Research Hospital
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RozzanoItalyUnknown status
Azienda Sanitaria Locale (ASL) Taranto
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TarantoItalyUnknown status
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
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UdineItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.