Uno studio osservazionale per valutare l'efficacia e la sicurezza di cemiplimab in pazienti con carcinoma polmonare non a piccole cellule avanzato (NSCLC) in contesti di pratica clinica di routine in Europa (CEMI-LUNG) (CEMI-LUNG)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Salzburg, Austria, 5020
- Salzburger Landeskliniken (SALK)
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Carinthia
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Klagenfurt, Carinthia, Austria, 9020
- Klinikum Klagenfurt
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Angers, Francia, 49000
- Centre Hospitalier Universitaire Angers
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Clermont-Ferrand, Francia, 63003
- Center Hospitalier Universitaire (CHU) of Clermont
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Le Mans, Francia, 72037
- Centre Hospitalier - Le mans
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Paris, Francia, 75020
- Hopital Tenon
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Alsace
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Mulhouse, Alsace, Francia, 68100
- Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
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Bas-Rhin
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Strasbourg, Bas-Rhin, Francia, 67000
- Hopitaux Universitaires de Strasbourg
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Francia, 13915
- APHM - Hopital Nord
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Vaucluse
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Avignon, Vaucluse, Francia, 84918
- Sainte Catherine Institut du Cancer Avignon Provence
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Vienne
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Poitiers, Vienne, Francia, 86021
- Centre Hospitalier Universitaire (CHU) de Poitiers
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Berlin, Germania, 14089
- Gemeinschaftskrankenhaus Havelhoehe
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Dortmund, Germania, 44263
- Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
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Halle, Germania, 06120
- Krankenhaus Martha-Maria Halle-Doelau gGmbH
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Baden-Wurttemberg
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Konstanz, Baden-Wurttemberg, Germania, 78464
- Klinikum Konstanz
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Bavaria
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München, Bavaria, Germania, 81925
- Staedtisches Klinikum Muenchen Bogenhausen
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Nuremberg, Bavaria, Germania, 90419
- Nuremberg Hospital, Campus North
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Georgsmarienhuette
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Georgsmarienhütte, Georgsmarienhuette, Germania, 49124
- Franziskus Hospital Harderberg
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Lower Saxony
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Rotenburg (Wümme), Lower Saxony, Germania, 27356
- Agaplesion Diakonieklinikum Rotenburg
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Germania, 48145
- St. Franziskus Hospital Münster
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Troisdorf, North Rhine-Westphalia, Germania, 53840
- Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
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Saxony
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Leipzig, Saxony, Germania, 4347
- Pneumologische Praxis PD Dr. Med Christian Gessner
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Catania, Italia, 95123
- AO Universitaria Policlinico Vittorio Emanuele
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Milan, Italia, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Modena, Italia, 41124
- Azienda Ospedaliero-Universitaria di Modena
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Naples, Italia, 80131
- Istituto Nazionale Tumori IRCCS Fondazione G Pascale
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Naples, Italia, 80131
- AORN dei Colli
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Pavia, Italia, 27100
- Fondazione IRCCS Policlinico San Matteo
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Taranto, Italia, 74010
- Azienda Sanitaria Locale (ASL) Taranto
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Catania
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Misterbianco, Catania, Italia, 95065
- Humanitas Istituto Clinico Catanese
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Firenze
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Florence, Firenze, Italia, 50134
- AOU Careggi
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Friuli Venezia Giulia
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Udine, Friuli Venezia Giulia, Italia, 33100
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
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Milan
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Rozzano, Milan, Italia, 20089
- IRCCS Humanitas Research Hospital
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Piedmont
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Orbassano, Piedmont, Italia, 10043
- San Luigi Gonzaga University Hospital
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Tuscany
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Pisa, Tuscany, Italia, 56126
- Ospedale Di Cisanello Azienda Ospedaliero Universitaria
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Almería, Spagna, 04009
- Hospital Torrecardenas
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Jaén, Spagna, 23007
- University Hospital of Jaen
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Lleida, Spagna, 25198
- Hospital Arnau de Vilanova
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Santa Cruz de Tenerife, Spagna, 38010
- Hospital Universitario Nuestra Senora de Candelaria
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Tarragona, Spagna, 43204
- Hospital Universitari Sant Joan de Reus
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Andalusia
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Málaga, Andalusia, Spagna, 29010
- Hospital Universitario Virgen De La Victoria Malaga
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Barcelona
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Sabadell, Barcelona, Spagna, 08208
- Parc Tauli Sabadell Hospital Universitari
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Cadiz
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Jerez de la Frontera, Cadiz, Spagna, 11407
- Hospital Universitario De Jerez
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Castellon
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Castellon, Castellon, Spagna, 12002
- Consorcio Hospitalario Provincial de Castellon
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Galicia
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Ferrol, Galicia, Spagna, 15405
- Complejo Hospitalario Universitario de Ferrol - Hospital Naval
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Vigo, Galicia, Spagna, 36204
- Hospital Universitario Alvaro Cunqueiro
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Cohort 1
Cemiplimab monotherapy |
solution for injection via intravenous (IV) infusion
Altri nomi:
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Cohort 2
Cemiplimab in combination with platinum-based chemotherapy |
solution for injection via intravenous (IV) infusion
Altri nomi:
IV administration |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall survival (OS)
Lasso di tempo: Up to 72 months
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Date and primary cause of death |
Up to 72 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall Response Rate (ORR)
Lasso di tempo: Up to 72 months
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Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response. |
Up to 72 months
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Duration of Response (DoR)
Lasso di tempo: Up to 72 months
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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. |
Up to 72 months
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Time to Response (TTR)
Lasso di tempo: Up to 72 months
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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). |
Up to 72 months
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Progression-Free Survival (PFS)
Lasso di tempo: Up to 72 months
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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. |
Up to 72 months
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Time to first subsequent anti-NSCLC treatment (TTST)
Lasso di tempo: Up to 72 months
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Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment. |
Up to 72 months
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Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Lasso di tempo: Up to 72 months
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Number of patients with treatment related adverse events occurring during treatment |
Up to 72 months
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Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Lasso di tempo: Up to 72 months
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Number of patients with serious treatment related adverse events occurring during treatment |
Up to 72 months
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Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Lasso di tempo: Up to 72 months
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Number of patients with immune-mediated adverse events and serious immune-mediated adverse events occurring during treatment |
Up to 72 months
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Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Lasso di tempo: Up to 72 months
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Number of patients with infusion related reactions and serious infusion related reactions adverse events occurring during treatment |
Up to 72 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Clinical Trial Management, Regeneron Pharmaceuticals
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R2810-ONC-2325
- U1111-1275-9867 (Identificatore di registro: ICTRP)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .