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Lung cancer drug under the microscope: how does cemiplimab perform in real life?

NCT ID NCT05363319

Knowledge-focused Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study follows 500 European patients with advanced non-small cell lung cancer who are already prescribed cemiplimab (Libtayo) as part of their normal care. Researchers will track how long patients live, how well the cancer responds, and any side effects. The goal is to see if the drug works as well in everyday clinics as it did in earlier clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cemiplimab (Libtayo) with or without platinum-based chemotherapy
What this could lead to
If successful, this study could confirm that cemiplimab works well in everyday clinical practice, not just in controlled trials, for advanced lung cancer.
What could go wrong
This is an observational study, not a controlled experiment, so results may be less reliable. It only looks at patients already prescribed the drug, so it cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The source population for this study will be patients with either locally advanced NSCLC not suitable for definitive chemoradiation or metastatic NSCLC and who are initiating a cemiplimab-based regimen of treatment as part of routine clinical practice at the time of study enrollment. The study will aim to enroll approximately 500 adult patients from up to 50 sites across Europe.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    44 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AO Universitaria Policlinico Vittorio Emanuele

    RECRUITING

    Catania, 95123, Italy

  • AORN dei Colli

    RECRUITING

    Naples, 80131, Italy

  • AOU Careggi

    RECRUITING

    Florence, Firenze, 50134, Italy

  • APHM - Hopital Nord

    RECRUITING

    Marseille, Bouches-du-Rhône, 13915, France

  • Agaplesion Diakonieklinikum Rotenburg

    RECRUITING

    Rotenburg (Wümme), Lower Saxony, 27356, Germany

  • Azienda Ospedaliero-Universitaria di Modena

    RECRUITING

    Modena, 41124, Italy

  • Azienda Sanitaria Locale (ASL) Taranto

    RECRUITING

    Taranto, 74010, Italy

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

    RECRUITING

    Udine, 33100, Italy

  • Center Hospitalier Universitaire (CHU) of Clermont

    COMPLETED

    Clermont-Ferrand, 63003, France

  • Centre Hospitalier - Le mans

    RECRUITING

    Le Mans, 72037, France

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    RECRUITING

    Poitiers, Vienne, 86021, France

  • Centre Hospitalier Universitaire Angers

    RECRUITING

    Angers, 49000, France

  • Complejo Hospitalario Universitario de Ferrol - Hospital Naval

    RECRUITING

    Ferrol, Galicia, 15405, Spain

  • Consorcio Hospitalario Provincial de Castellon

    RECRUITING

    Castellon, Castellon, 12002, Spain

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • Franziskus Hospital Harderberg

    RECRUITING

    Georgsmarienhütte, Georgsmarienhuette, 49124, Germany

  • Gemeinschaftskrankenhaus Havelhoehe

    RECRUITING

    Berlin, 14089, Germany

  • Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)

    RECRUITING

    Dortmund, 44263, Germany

  • Haematologisch Onkologische Schwerpunktpraxis - Troisdorf

    RECRUITING

    Troisdorf, North Rhine-Westphalia, 53840, Germany

  • Hopital Tenon

    RECRUITING

    Paris, 75020, France

  • Hopitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, Bas-Rhin, 67000, France

  • Hospital Arnau de Vilanova

    RECRUITING

    Lleida, 25198, Spain

  • Hospital Torrecardenas

    RECRUITING

    Almería, 04009, Spain

  • Hospital Universitari Sant Joan de Reus

    RECRUITING

    Tarragona, 43204, Spain

  • Hospital Universitario Alvaro Cunqueiro

    RECRUITING

    Vigo, Galicia, 36204, Spain

  • Hospital Universitario De Jerez

    RECRUITING

    Jerez de la Frontera, Cadiz, 11407, Spain

  • Hospital Universitario Nuestra Senora de Candelaria

    RECRUITING

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Virgen De La Victoria Malaga

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Humanitas Istituto Clinico Catanese

    RECRUITING

    Misterbianco, Catania, 95065, Italy

  • IRCCS Humanitas Research Hospital

    RECRUITING

    Rozzano, Milan, 20089, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G Pascale

    RECRUITING

    Naples, 80131, Italy

  • Klinikum Chemnitz gGmbH

    WITHDRAWN

    Chemnitz, Saxony, 09116, Germany

  • Klinikum Klagenfurt

    RECRUITING

    Klagenfurt, Carinthia, 9020, Austria

  • Klinikum Konstanz

    RECRUITING

    Konstanz, Baden-Wurttemberg, 78464, Germany

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    RECRUITING

    Halle, 06120, Germany

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

    RECRUITING

    Mulhouse, Alsace, 68100, France

  • Marienhaus Klinikum Mainz

    WITHDRAWN

    Mainz, 55131, Germany

  • MedFISMO

    WITHDRAWN

    Weinsberg, Baden-Wurttemberg, 74189, Germany

  • Nuremberg Hospital, Campus North

    COMPLETED

    Nuremberg, Bavaria, 90419, Germany

  • Ospedale Di Cisanello Azienda Ospedaliero Universitaria

    RECRUITING

    Pisa, Tuscany, 56126, Italy

  • Parc Tauli Sabadell Hospital Universitari

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Pneumologische Praxis PD Dr. Med Christian Gessner

    RECRUITING

    Leipzig, Saxony, 4347, Germany

  • Sainte Catherine Institut du Cancer Avignon Provence

    RECRUITING

    Avignon, Vaucluse, 84918, France

  • Salzburger Landeskliniken (SALK)

    RECRUITING

    Salzburg, 5020, Austria

  • San Luigi Gonzaga University Hospital

    RECRUITING

    Orbassano, Piedmont, 10043, Italy

  • St. Franziskus Hospital Münster

    RECRUITING

    Münster, North Rhine-Westphalia, 48145, Germany

  • Staedtisches Klinikum Muenchen Bogenhausen

    RECRUITING

    München, Bavaria, 81925, Germany

  • University Hospital of Jaen

    RECRUITING

    Jaén, 23007, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.