유럽의 일상적인 임상 진료 환경에서 진행성 비소세포폐암(NSCLC) 환자를 대상으로 세미플리맙의 효과 및 안전성을 평가하기 위한 관찰 연구(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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Berlin, 독일, 14089
- Gemeinschaftskrankenhaus Havelhoehe
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Dortmund, 독일, 44263
- Gesellschaft fur Onkologische Studien Dortmund mbH (Gefos)
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Halle, 독일, 06120
- Krankenhaus Martha-Maria Halle-Doelau gGmbH
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Baden-Wurttemberg
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Konstanz, Baden-Wurttemberg, 독일, 78464
- Klinikum Konstanz
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Bavaria
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München, Bavaria, 독일, 81925
- Staedtisches Klinikum Muenchen Bogenhausen
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Nuremberg, Bavaria, 독일, 90419
- Nuremberg Hospital, Campus North
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Georgsmarienhuette
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Georgsmarienhütte, Georgsmarienhuette, 독일, 49124
- Franziskus Hospital Harderberg
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Lower Saxony
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Rotenburg (Wümme), Lower Saxony, 독일, 27356
- Agaplesion Diakonieklinikum Rotenburg
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, 독일, 48145
- St. Franziskus Hospital Münster
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Troisdorf, North Rhine-Westphalia, 독일, 53840
- Haematologisch Onkologische Schwerpunktpraxis - Troisdorf
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Saxony
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Leipzig, Saxony, 독일, 4347
- Pneumologische Praxis PD Dr. Med Christian Gessner
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Almería, 스페인, 04009
- Hospital Torrecardenas
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Jaén, 스페인, 23007
- University Hospital of Jaen
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Lleida, 스페인, 25198
- Hospital Arnau de Vilanova
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Santa Cruz de Tenerife, 스페인, 38010
- Hospital Universitario Nuestra Senora de Candelaria
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Tarragona, 스페인, 43204
- Hospital Universitari Sant Joan de Reus
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Andalusia
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Málaga, Andalusia, 스페인, 29010
- Hospital Universitario Virgen De La Victoria Malaga
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Barcelona
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Sabadell, Barcelona, 스페인, 08208
- Parc Tauli Sabadell Hospital Universitari
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Cadiz
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Jerez de la Frontera, Cadiz, 스페인, 11407
- Hospital Universitario De Jerez
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Castellon
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Castellon, Castellon, 스페인, 12002
- Consorcio Hospitalario Provincial de Castellon
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Galicia
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Ferrol, Galicia, 스페인, 15405
- Complejo Hospitalario Universitario de Ferrol - Hospital Naval
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Vigo, Galicia, 스페인, 36204
- Hospital Universitario Alvaro Cunqueiro
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Salzburg, 오스트리아, 5020
- Salzburger Landeskliniken (SALK)
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Carinthia
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Klagenfurt, Carinthia, 오스트리아, 9020
- Klinikum Klagenfurt
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Catania, 이탈리아, 95123
- AO Universitaria Policlinico Vittorio Emanuele
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Milan, 이탈리아, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Modena, 이탈리아, 41124
- Azienda Ospedaliero-Universitaria di Modena
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Naples, 이탈리아, 80131
- Istituto Nazionale Tumori IRCCS Fondazione G Pascale
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Naples, 이탈리아, 80131
- AORN dei Colli
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Pavia, 이탈리아, 27100
- Fondazione IRCCS Policlinico San Matteo
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Taranto, 이탈리아, 74010
- Azienda Sanitaria Locale (ASL) Taranto
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Catania
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Misterbianco, Catania, 이탈리아, 95065
- Humanitas Istituto Clinico Catanese
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Firenze
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Florence, Firenze, 이탈리아, 50134
- AOU Careggi
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Friuli Venezia Giulia
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Udine, Friuli Venezia Giulia, 이탈리아, 33100
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
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Milan
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Rozzano, Milan, 이탈리아, 20089
- IRCCS Humanitas Research Hospital
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Piedmont
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Orbassano, Piedmont, 이탈리아, 10043
- San Luigi Gonzaga University Hospital
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Tuscany
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Pisa, Tuscany, 이탈리아, 56126
- Ospedale Di Cisanello Azienda Ospedaliero Universitaria
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Angers, 프랑스, 49000
- Centre Hospitalier Universitaire Angers
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Clermont-Ferrand, 프랑스, 63003
- Center Hospitalier Universitaire (CHU) of Clermont
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Le Mans, 프랑스, 72037
- Centre Hospitalier - Le mans
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Paris, 프랑스, 75020
- Hopital Tenon
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Alsace
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Mulhouse, Alsace, 프랑스, 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, 프랑스, 67000
- Hopitaux Universitaires de Strasbourg
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, 프랑스, 13915
- APHM - Hopital Nord
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Vaucluse
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Avignon, Vaucluse, 프랑스, 84918
- Sainte Catherine Institut du Cancer Avignon Provence
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Vienne
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Poitiers, Vienne, 프랑스, 86021
- Centre Hospitalier Universitaire (CHU) de Poitiers
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Cohort 1
Cemiplimab monotherapy |
solution for injection via intravenous (IV) infusion
다른 이름들:
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|
Cohort 2
Cemiplimab in combination with platinum-based chemotherapy |
solution for injection via intravenous (IV) infusion
다른 이름들:
IV administration |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall survival (OS)
기간: Up to 72 months
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Date and primary cause of death |
Up to 72 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Response Rate (ORR)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
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공동 작업자 및 조사자
수사관
- 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .