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

Официальное название

An Observational Study to Assess the Effectiveness and Safety of Cemiplimab Based Regimen in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Cemiplimab
  solution for injection via intravenous (IV) infusion
• Препарат Platinum-based chemotherapy
  IV administration

Первичные конечные точки

• Overall survival (OS) [Срок оценки: Up to 72 months]

Вторичные конечные точки (9)

• Overall Response Rate (ORR) [Срок оценки: Up to 72 months]
• Duration of Response (DoR) [Срок оценки: Up to 72 months]
• Time to Response (TTR) [Срок оценки: Up to 72 months]
• Progression-Free Survival (PFS) [Срок оценки: Up to 72 months]
• Time to first subsequent anti-NSCLC treatment (TTST) [Срок оценки: Up to 72 months]
• Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice [Срок оценки: Up to 72 months]
• Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice [Срок оценки: Up to 72 months]
• Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice [Срок оценки: 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 [Срок оценки: Up to 72 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 14 центров

• Klinikum Konstanz — Konstanz
• MedFISMO — Weinsberg
• Staedtisches Klinikum Muenchen Bogenhausen — München
• Nuremberg Hospital, Campus North — Nuremberg
• Franziskus Hospital Harderberg — Georgsmarienhütte
• Agaplesion Diakonieklinikum Rotenburg — Rotenburg (Wümme)
• St. Franziskus Hospital Münster — Münster
• Haematologisch Onkologische Schwerpunktpraxis - Troisdorf — Troisdorf
• … и ещё 6 центров

Италия · 13 центров

• Humanitas Istituto Clinico Catanese — Misterbianco
• AOU Careggi — Florence
• IRCCS Humanitas Research Hospital — Rozzano
• San Luigi Gonzaga University Hospital — Orbassano
• Ospedale Di Cisanello Azienda Ospedaliero Universitaria — Pisa
• AO Universitaria Policlinico Vittorio Emanuele — Catania
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
• Azienda Ospedaliero-Universitaria di Modena — Modena
• … и ещё 5 центров

Испания · 11 центров

• Hospital Universitario Virgen De La Victoria Malaga — Málaga
• Parc Tauli Sabadell Hospital Universitari — Sabadell
• Hospital Universitario De Jerez — Jerez de la Frontera
• Consorcio Hospitalario Provincial de Castellon — Castellon
• Complejo Hospitalario Universitario de Ferrol - Hospital Naval — Ferrol
• Hospital Universitario Alvaro Cunqueiro — Vigo
• Hospital Torrecardenas — Almería
• University Hospital of Jaen — Jaén
• … и ещё 3 центра

Франция · 9 центров

• Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital — Mulhouse
• Hopitaux Universitaires de Strasbourg — Strasbourg
• APHM - Hopital Nord — Marseille
• Sainte Catherine Institut du Cancer Avignon Provence — Avignon
• Centre Hospitalier Universitaire (CHU) de Poitiers — Poitiers
• Centre Hospitalier Universitaire Angers — Angers
• Center Hospitalier Universitaire (CHU) of Clermont — Clermont-Ferrand
• Centre Hospitalier - Le mans — Le Mans
• … и ещё 1 центр

Австрия · 2 центра

• Klinikum Klagenfurt — Klagenfurt
• Salzburger Landeskliniken (SALK) — Salzburg

Идентификаторы

NCT: NCT05363319 · R2810-ONC-2325 · U1111-1275-9867

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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