Un estudio observacional para evaluar la eficacia y la seguridad de cemiplimab en pacientes con cáncer de pulmón de células no pequeñas (NSCLC) avanzado en entornos de práctica clínica de rutina en 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 14089
- Gemeinschaftskrankenhaus Havelhoehe
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Dortmund, Alemania, 44263
- Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
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Halle, Alemania, 06120
- Krankenhaus Martha-Maria Halle-Doelau gGmbH
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Baden-Wurttemberg
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Konstanz, Baden-Wurttemberg, Alemania, 78464
- Klinikum Konstanz
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Bavaria
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München, Bavaria, Alemania, 81925
- Staedtisches Klinikum Muenchen Bogenhausen
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Nuremberg, Bavaria, Alemania, 90419
- Nuremberg Hospital, Campus North
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Georgsmarienhuette
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Georgsmarienhütte, Georgsmarienhuette, Alemania, 49124
- Franziskus Hospital Harderberg
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Lower Saxony
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Rotenburg (Wümme), Lower Saxony, Alemania, 27356
- Agaplesion Diakonieklinikum Rotenburg
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Alemania, 48145
- St. Franziskus Hospital Münster
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Troisdorf, North Rhine-Westphalia, Alemania, 53840
- Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
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Saxony
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Leipzig, Saxony, Alemania, 4347
- Pneumologische Praxis PD Dr. Med Christian Gessner
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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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Almería, España, 04009
- Hospital Torrecardenas
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Jaén, España, 23007
- University Hospital of Jaen
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Lleida, España, 25198
- Hospital Arnau de Vilanova
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Santa Cruz de Tenerife, España, 38010
- Hospital Universitario Nuestra Senora de Candelaria
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Tarragona, España, 43204
- Hospital Universitari Sant Joan de Reus
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Andalusia
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Málaga, Andalusia, España, 29010
- Hospital Universitario Virgen De La Victoria Malaga
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Barcelona
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Sabadell, Barcelona, España, 08208
- Parc Tauli Sabadell Hospital Universitari
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Cadiz
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Jerez de la Frontera, Cadiz, España, 11407
- Hospital Universitario De Jerez
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Castellon
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Castellon, Castellon, España, 12002
- Consorcio Hospitalario Provincial de Castellon
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Galicia
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Ferrol, Galicia, España, 15405
- Complejo Hospitalario Universitario de Ferrol - Hospital Naval
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Vigo, Galicia, España, 36204
- Hospital Universitario Alvaro Cunqueiro
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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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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Cohort 1
Cemiplimab monotherapy |
solution for injection via intravenous (IV) infusion
Otros nombres:
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Cohort 2
Cemiplimab in combination with platinum-based chemotherapy |
solution for injection via intravenous (IV) infusion
Otros nombres:
IV administration |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall survival (OS)
Periodo de tiempo: Up to 72 months
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Date and primary cause of death |
Up to 72 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Response Rate (ORR)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Clinical Trial Management, Regeneron Pharmaceuticals
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma de pulmón de células no pequeñas
- Químicos inorgánicos
- Compuestos de platino
- cemiplimab
Otros números de identificación del estudio
- R2810-ONC-2325
- U1111-1275-9867 (Identificador de registro: ICTRP)
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