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Non-small Cell Lung CancerCEMI-LUNGNCT05363319

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 of Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 46 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Cemiplimab and Platinum-based chemotherapy
Type of treatment
Injection or infusion
How many people
509 participants
Where
46 sitesin 5 countries
Study dates
26 Oct 2022to 3 Oct 2028
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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
  • NOTE: Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

46 sites in 5 countries.

46 sites in 5 countries

Italy13 sites

  • AO Universitaria Policlinico Vittorio Emanuele

    Catania, 95123

  • AOU Careggi

    Florence, Firenze, 50134

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Humanitas Istituto Clinico Catanese

    Misterbianco, Catania, 95065

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41124

  • AORN dei Colli

    Naples, 80131

  • Istituto Nazionale Tumori IRCCS Fondazione G Pascale

    Naples, 80131

  • San Luigi Gonzaga University Hospital

    Orbassano, Piedmont, 10043

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Ospedale Di Cisanello Azienda Ospedaliero Universitaria

    Pisa, Tuscany, 56126

  • IRCCS Humanitas Research Hospital

    Rozzano, Milan, 20089

  • Azienda Sanitaria Locale (ASL) Taranto

    Taranto, 74010

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

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Germany11 sites

  • Gemeinschaftskrankenhaus Havelhoehe

    Berlin, 14089

  • Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)

    Dortmund, 44263

  • Franziskus Hospital Harderberg

    Georgsmarienhütte, Georgsmarienhuette, 49124

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120

  • Klinikum Konstanz

    Konstanz, Baden-Wurttemberg, 78464

  • Pneumologische Praxis PD Dr. Med Christian Gessner

    Leipzig, Saxony, 4347

  • Staedtisches Klinikum Muenchen Bogenhausen

    München, Bavaria, 81925

  • St. Franziskus Hospital Münster

    Münster, North Rhine-Westphalia, 48145

  • Nuremberg Hospital, Campus North

    Nuremberg, Bavaria, 90419

  • Agaplesion Diakonieklinikum Rotenburg

    Rotenburg (Wümme), Lower Saxony, 27356

  • Haematologisch Onkologische Schwerpunktpraxis - Troisdorf

    Troisdorf, North Rhine-Westphalia, 53840

Other trials in Germany

Spain11 sites

  • Hospital Torrecardenas

    Almería, 04009

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Castellon, 12002

  • Complejo Hospitalario Universitario de Ferrol - Hospital Naval

    Ferrol, Galicia, 15405

  • University Hospital of Jaen

    Jaén, 23007

  • Hospital Universitario De Jerez

    Jerez de la Frontera, Cadiz, 11407

  • Hospital Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario Virgen De La Victoria Malaga

    Málaga, Andalusia, 29010

  • Parc Tauli Sabadell Hospital Universitari

    Sabadell, Barcelona, 08208

  • Hospital Universitario Nuestra Senora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitari Sant Joan de Reus

    Tarragona, 43204

  • Hospital Universitario Alvaro Cunqueiro

    Vigo, Galicia, 36204

Other trials in Spain

France9 sites

  • Centre Hospitalier Universitaire Angers

    Angers, 49000

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, Vaucluse, 84918

  • Center Hospitalier Universitaire (CHU) of Clermont

    Clermont-Ferrand, 63003

  • Centre Hospitalier - Le mans

    Le Mans, 72037

  • APHM - Hopital Nord

    Marseille, Bouches-du-Rhône, 13915

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

    Mulhouse, Alsace, 68100

  • Hopital Tenon

    Paris, 75020

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, Vienne, 86021

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, Bas-Rhin, 67000

Other trials in France

Austria2 sites

  • Klinikum Klagenfurt

    Klagenfurt, Carinthia, 9020

  • Salzburger Landeskliniken (SALK)

    Salzburg, 5020

Other trials in Austria

About this study

Official title: 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)

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.

Read the detailed 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.

Being tested
Cemiplimab, Platinum-based chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    Also called SAR439684- Libtayo

    solution for injection via intravenous (IV) infusion

  • Platinum-based chemotherapyDrug

    IV administration

Study groups in NCT05363319
Study groupRoleWhat they receive
Cohort 1Cemiplimab monotherapy
Receives: Drug: Cemiplimab
Cohort 2Cemiplimab in combination with platinum-based chemotherapy
Receives: Drug: Cemiplimab; Drug: Platinum-based chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Date and primary cause of death

    Measured: Up to 72 months

Secondary outcomes (9)

  1. Overall Response Rate (ORR)

    Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response.

    Measured: Up to 72 months

  2. Duration of Response (DoR)

    Defined among responders (patients with a complete response or partial response) as the time from the date of the first response after cemiplimab treatment initiation until the first date of disease progression or death due to any cause.

    Measured: Up to 72 months

  3. Time to Response (TTR)

    Defined as the time from the first cemiplimab dose until the date of first response observed for that patient. Patients who die during the study will be censored using the date of the last valid disease assessment).

    Measured: Up to 72 months

  4. Progression-Free Survival (PFS)

    Defined as the time from the first dose of cemiplimab until the date of the first documented tumour progression or death due to any cause.

    Measured: Up to 72 months

  5. Time to first subsequent anti-NSCLC treatment (TTST)

    Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment.

    Measured: Up to 72 months

  6. Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

    Number of patients with treatment related adverse events occurring during treatment

    Measured: Up to 72 months

  7. Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

    Number of patients with serious treatment related adverse events occurring during treatment

    Measured: Up to 72 months

  8. Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

    Number of patients with immune-mediated adverse events and serious immune-mediated adverse events occurring during treatment

    Measured: Up to 72 months

  9. Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

    Number of patients with infusion related reactions and serious infusion related reactions adverse events occurring during treatment

    Measured: Up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start26 Oct 2022
  3. Primary completion3 Oct 2028 (estimated)
  4. Study completion3 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
509 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363319
Sponsor's protocol ID
R2810-ONC-2325
Other IDs
U1111-1275-9867
Acronym
CEMI-LUNG
Status last verified
Oct 2026
First submitted
2 May 2022
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 46 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Italy, Germany, Spain, France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Up to 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05363319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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