Observační studie k posouzení účinnosti a bezpečnosti cemiplimabu u pacientů s pokročilým nemalobuněčným karcinomem plic (NSCLC) v prostředí rutinní klinické praxe v Evropě (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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Angers, Francie, 49000
- Centre Hospitalier Universitaire Angers
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Clermont-Ferrand, Francie, 63003
- Center Hospitalier Universitaire (CHU) of Clermont
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Le Mans, Francie, 72037
- Centre Hospitalier - Le mans
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Paris, Francie, 75020
- Hopital Tenon
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Alsace
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Mulhouse, Alsace, Francie, 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, Francie, 67000
- Hopitaux Universitaires de Strasbourg
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Francie, 13915
- APHM - Hopital Nord
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Vaucluse
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Avignon, Vaucluse, Francie, 84918
- Sainte Catherine Institut du Cancer Avignon Provence
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Vienne
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Poitiers, Vienne, Francie, 86021
- Centre Hospitalier Universitaire (CHU) de Poitiers
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Catania, Itálie, 95123
- AO Universitaria Policlinico Vittorio Emanuele
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Milan, Itálie, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Modena, Itálie, 41124
- Azienda Ospedaliero-Universitaria di Modena
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Naples, Itálie, 80131
- Istituto Nazionale Tumori IRCCS Fondazione G Pascale
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Naples, Itálie, 80131
- AORN dei Colli
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Pavia, Itálie, 27100
- Fondazione IRCCS Policlinico San Matteo
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Taranto, Itálie, 74010
- Azienda Sanitaria Locale (ASL) Taranto
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Catania
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Misterbianco, Catania, Itálie, 95065
- Humanitas Istituto Clinico Catanese
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Firenze
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Florence, Firenze, Itálie, 50134
- AOU Careggi
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Friuli Venezia Giulia
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Udine, Friuli Venezia Giulia, Itálie, 33100
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
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Milan
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Rozzano, Milan, Itálie, 20089
- IRCCS Humanitas Research Hospital
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Piedmont
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Orbassano, Piedmont, Itálie, 10043
- San Luigi Gonzaga University Hospital
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Tuscany
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Pisa, Tuscany, Itálie, 56126
- Ospedale Di Cisanello Azienda Ospedaliero Universitaria
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Berlin, Německo, 14089
- Gemeinschaftskrankenhaus Havelhoehe
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Dortmund, Německo, 44263
- Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
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Halle, Německo, 06120
- Krankenhaus Martha-Maria Halle-Doelau gGmbH
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Baden-Wurttemberg
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Konstanz, Baden-Wurttemberg, Německo, 78464
- Klinikum Konstanz
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Bavaria
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München, Bavaria, Německo, 81925
- Staedtisches Klinikum Muenchen Bogenhausen
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Nuremberg, Bavaria, Německo, 90419
- Nuremberg Hospital, Campus North
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Georgsmarienhuette
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Georgsmarienhütte, Georgsmarienhuette, Německo, 49124
- Franziskus Hospital Harderberg
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Lower Saxony
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Rotenburg (Wümme), Lower Saxony, Německo, 27356
- Agaplesion Diakonieklinikum Rotenburg
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Německo, 48145
- St. Franziskus Hospital Münster
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Troisdorf, North Rhine-Westphalia, Německo, 53840
- Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
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Saxony
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Leipzig, Saxony, Německo, 4347
- Pneumologische Praxis PD Dr. Med Christian Gessner
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Salzburg, Rakousko, 5020
- Salzburger Landeskliniken (SALK)
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Carinthia
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Klagenfurt, Carinthia, Rakousko, 9020
- Klinikum Klagenfurt
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Almería, Španělsko, 04009
- Hospital Torrecardenas
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Jaén, Španělsko, 23007
- University Hospital of Jaen
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Lleida, Španělsko, 25198
- Hospital Arnau de Vilanova
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Santa Cruz de Tenerife, Španělsko, 38010
- Hospital Universitario Nuestra Senora de Candelaria
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Tarragona, Španělsko, 43204
- Hospital Universitari Sant Joan de Reus
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Andalusia
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Málaga, Andalusia, Španělsko, 29010
- Hospital Universitario Virgen De La Victoria Malaga
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Barcelona
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Sabadell, Barcelona, Španělsko, 08208
- Parc Tauli Sabadell Hospital Universitari
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Cadiz
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Jerez de la Frontera, Cadiz, Španělsko, 11407
- Hospital Universitario De Jerez
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Castellon
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Castellon, Castellon, Španělsko, 12002
- Consorcio Hospitalario Provincial de Castellon
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Galicia
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Ferrol, Galicia, Španělsko, 15405
- Complejo Hospitalario Universitario de Ferrol - Hospital Naval
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Vigo, Galicia, Španělsko, 36204
- Hospital Universitario Alvaro Cunqueiro
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Cohort 1
Cemiplimab monotherapy |
solution for injection via intravenous (IV) infusion
Ostatní jména:
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Cohort 2
Cemiplimab in combination with platinum-based chemotherapy |
solution for injection via intravenous (IV) infusion
Ostatní jména:
IV administration |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall survival (OS)
Časové okno: Up to 72 months
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Date and primary cause of death |
Up to 72 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall Response Rate (ORR)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Up to 72 months
|
Number of patients with immune-mediated adverse events and serious immune-mediated adverse events occurring during treatment |
Up to 72 months
|
|
Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Časové okno: Up to 72 months
|
Number of patients with infusion related reactions and serious infusion related reactions adverse events occurring during treatment |
Up to 72 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Clinical Trial Management, Regeneron Pharmaceuticals
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R2810-ONC-2325
- U1111-1275-9867 (Identifikátor registru: ICTRP)
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