Исследование клинических исходов у пациентов с EGFR-мутированным распространенным немелкоклеточным раком легкого (НМРЛ) в реальной клинической практике (LEPIDOPTERA)
Проспективное, многострановое, обсервационное исследование клинических исходов у пациентов с EGFR-мутированным распространенным немелкоклеточным раком легкого (НМРЛ), получающих одобренные режимы лечения, содержащие амивантамаб, в условиях стандартной клинической практики
The purpose of this study is to describe the clinical and health-related outcomes of amivantamab-containing regimens for the treatment of common epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC; most common type of lung cancer) in a real-world setting. Metastatic NSCLC is when this disease spreads to other parts of body. NSCLC may occur due to mutations (changes) in many genes including epidermal growth factor receptor (EGFR).
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Study Contact
- Номер телефона: 844-434-4210
- Электронная почта: Participate-In-This-Study1@its.jnj.com
Места учебы
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Graz, Австрия, 8036
- Рекрутинг
- University Hospital Graz
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Klagenfurt, Австрия, 9020
- Рекрутинг
- Klinikum Klagenfurt am Worthersee
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Natters, Австрия, 6161
- Рекрутинг
- Landeskrankenhaus Hochzirl Natters
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Brussels, Бельгия, 1090
- Рекрутинг
- UZ Brussel
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Edegem, Бельгия, 2650
- Рекрутинг
- UZ Antwerpen
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Hasselt, Бельгия, 3500
- Рекрутинг
- Jessa Ziekenhuis
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Kortrijk, Бельгия, 8500
- Рекрутинг
- Az Groeninge
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La Louvière, Бельгия, 7100
- Рекрутинг
- Chu Helora Hospital La Louviere Site Jolimont
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Liège, Бельгия, 4000
- Рекрутинг
- CHU de Liege
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Sint-Niklaas, Бельгия, 9100
- Рекрутинг
- Vitaz
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Aschaffenburg, Германия, 63739
- Рекрутинг
- MVZ am Klinikum Aschaffenburg Onkologie
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Bielefeld, Германия, 33611
- Рекрутинг
- Evangelisches Klinikum Bethel
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Bochum, Германия, 44791
- Рекрутинг
- Augusta Kliniken Bochum Hattingen
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Bremen, Германия, 28325
- Рекрутинг
- Gesundheit Nord - Klinikverbund Bremen
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Chemnitz, Германия, 09113
- Рекрутинг
- Klinikum Chemnitz gGmbH
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Cologne, Германия, 50677
- Рекрутинг
- Haematologie u Onkologie Koeln MV Zentrum
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Cologne, Германия, 51109
- Рекрутинг
- Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
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Düsseldorf, Германия, 40489
- Рекрутинг
- Florence Nightingale Krankenhaus
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Essen, Германия, 45147
- Рекрутинг
- Universitaetsklinikum Essen
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Essen, Германия, 45136
- Рекрутинг
- Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
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Hamburg, Германия, 20249
- Рекрутинг
- Facharztzentrum Eppendorf
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Hanover, Германия, 30625
- Рекрутинг
- Medizinische Hochschule Hannover
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Hanover, Германия, 30161
- Рекрутинг
- Onkologie am Raschplatz
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Hanover, Германия, 30449
- Рекрутинг
- Klinikum Region Hannover Klinikum Siloah
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Hemer, Германия, 58675
- Рекрутинг
- Lungenklinik Hemer
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Konstanz, Германия, 78464
- Рекрутинг
- Klinikum Konstanz
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Landshut, Германия, 84034
- Рекрутинг
- LA Regio Kliniken Klinik Landshut Mitte
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Neuss, Германия, 41462
- Рекрутинг
- MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH
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Recklinghausen, Германия, 45659
- Рекрутинг
- Knappschaft Kliniken MVZ Nord GmbH
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Solingen, Германия, 42699
- Рекрутинг
- Hospital Bethanien Solingen
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Stolberg, Германия, 52222
- Рекрутинг
- MVZ Onkologie Groschek Keller
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Ulm, Германия, 89081
- Рекрутинг
- Bundeswehrkrankenhaus Ulm
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Petah Tikva, Израиль, 4941492
- Рекрутинг
- Rabin Medical Center
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Ramat Gan, Израиль, 5262000
- Рекрутинг
- Sheba Medical Center
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Tel Aviv, Израиль, 6971028
- Рекрутинг
- Assuta MC
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A Coruña, Испания, 15006
- Рекрутинг
- Hosp Univ A Coruna
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Burgos, Испания, 09006
- Рекрутинг
- Hosp. Univ. de Burgos
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Córdoba, Испания, 14004
- Рекрутинг
- Hosp Reina Sofia
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Jerez de la Frontera, Испания, 11407
- Рекрутинг
- Hosp. de Jerez de La Frontera
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Lugo, Испания, 27003
- Рекрутинг
- Hosp. Univ. Lucus Augusti
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Málaga, Испания, 29011
- Рекрутинг
- Hosp Regional Univ de Malaga
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Ourense, Испания, 32005
- Рекрутинг
- Complexo Hosp. Univ. de Ourense
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Palma de Mallorca, Испания, 07120
- Рекрутинг
- Hosp. Univ. Son Espases
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Santiago de Compostela, Испания, 15706
- Рекрутинг
- Hosp. Clinico Univ. de Santiago
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Seville, Испания, 41013
- Рекрутинг
- Hospital Universitario Virgen Rocio
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Valladolid, Испания, 47003
- Рекрутинг
- Hosp. Clinico Univ. de Valladolid
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Vigo, Испания, 36312
- Рекрутинг
- Hosp. Alvaro Cunqueiro
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Avellino, Италия, 83100
- Рекрутинг
- Ospedale San Giuseppe Moscati di Avellino
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Aviano, Италия, 33081
- Рекрутинг
- CRO IRCCS Istituto Nazionale Tumori
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Bari, Италия, 70124
- Рекрутинг
- Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
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Bergamo, Италия, 24127
- Рекрутинг
- ASST Papa Giovanni XXIII Bergamo
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Brescia, Италия, 25123
- Рекрутинг
- ASST Spedali Civili Brescia
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Candiolo, Италия, 10060
- Рекрутинг
- Istituto di Candiolo, IRCCS
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Catania, Италия, 95123
- Рекрутинг
- PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
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Catanzaro, Италия, 88100
- Рекрутинг
- Azienda Ospedaliera Pugliese Ciaccio Catanzaro
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Genova, Италия, 16132
- Рекрутинг
- Ospedale Policlinico San Martino IRCCS
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Lecce, Италия, 73100
- Рекрутинг
- Azienda Ospedaliera ''Vito Fazzi''
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Milan, Италия, 20162
- Рекрутинг
- ASST Grande Ospedale Metropolitano Niguarda
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Milan, Италия, 20132
- Рекрутинг
- San Raffaele Hospital
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Milan, Италия, 20133
- Рекрутинг
- Istituto Dei Tumori Di Milano
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Milan, Италия, 20141
- Рекрутинг
- European Institute of Oncology
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Monza, Италия, 20900
- Рекрутинг
- San Gerardo Hospital
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Naples, Италия, 80131
- Рекрутинг
- Fondazione G Pascale Istituto Nazionale Tumori IRCCS
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Naples, Италия, 80131
- Рекрутинг
- Universita degli Studi della Campania Luigi Vanvitelli
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Novara, Италия, 28100
- Рекрутинг
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
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Olbia, Италия, 07026
- Рекрутинг
- ASL Gallura - Ospedale Giovanni Paolo II
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Orbassano, Италия, 10043
- Рекрутинг
- Aou San Luigi Gonzaga
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Palermo, Италия, 90127
- Рекрутинг
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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Palermo, Италия, 90146
- Рекрутинг
- A.O.R Villa Sofia Cervello
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Parma, Италия, 43126
- Рекрутинг
- Azienda Ospedaliero-Universitaria Di Parma
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Pisa, Италия, 56124
- Рекрутинг
- Azienda Ospedaliero Universitaria Pisana
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Ravenna, Италия, 48121
- Рекрутинг
- U.O.C. Ematologia Ospedale S. Maria delle Croci
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Roma, Италия, 00168
- Рекрутинг
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, Италия, 128
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- Campus Bio Medico di Roma
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Rome, Италия, 00144
- Рекрутинг
- Istituto Nazionale Tumori Regina Elena
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Sassari, Италия, 07100
- Рекрутинг
- Azienda Ospedaliero Universitaria di Sassari
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Torrette-Ancona, Италия, 60126
- Рекрутинг
- Ospedali Riuniti Di Ancona
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Urbino, Италия, 61121
- Рекрутинг
- Azienda Sanitaria Territoriale Pesaro Urbino
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Bath, Соединенное Королевство, BA1 3NG
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- Royal United Hospital
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Cardiff, Соединенное Королевство, CF14 2TL
- Рекрутинг
- Velindre Hospital
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Eastbourne, Соединенное Королевство, BN21 2UD
- Рекрутинг
- Eastbourne District General Hospital
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Guildford, Соединенное Королевство, GU2 7XX
- Рекрутинг
- Royal Surrey County Hospital NHS Trust
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Heath Town, Соединенное Королевство, WV10 0QP
- Рекрутинг
- New Cross Hospital
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London, Соединенное Королевство, SW3 6JJ
- Рекрутинг
- Royal Marsden Hospital
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Manchester, Соединенное Королевство, M20 4BX
- Рекрутинг
- The Christie NHS Foundation Trust Christie Hospital
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Sutton, Соединенное Королевство, SM2 5PT
- Рекрутинг
- Royal Marsden Hospital (Sutton)
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Brno, Чехия, 625 00
- Рекрутинг
- Fakultni nemocnice Brno
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Hradec Králové, Чехия, 500 05
- Рекрутинг
- Fakultni nemocnice Hradec Kralove
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Olomouc, Чехия, 77900
- Рекрутинг
- Fakultni nemocnice Olomouc
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Prague, Чехия, 140 59
- Рекрутинг
- Fakultni Thomayerova nemocnice
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
The study population will include participants with advanced NSCLC.
Описание
Inclusion Criteria:
- Participant has a confirmed diagnosis of common epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) (EGFR exon 19 deletions or exon 21 L858R substitution) and is eligible for an amivantamab-containing regimen per the judgment of the treating physician and in alignment with the approved amivantamab indications and recommended prophylactic and reactive medication as described in the local specific summary of product characteristics (SmPC) for amivantamab
- Participants or their legally acceptable representative, where applicable, must sign a participation agreement/Informed consent form (ICF) allowing source data verification in accordance with local requirements
- Participant is being planned to be initiated with an amivantamab-containing regimen for the first time within 4 weeks following the visit for start of data collection
- Decision to administer an amivantamab-containing regimen has been made prior to participant's enrollment in the study and is separate from the physician's decision to include the participant in the current study
Exclusion criteria:
- At the time of the initiation of the amivantamab-containing regimen, the participant is receiving an active systemic anticancer treatment for advanced NSCLC that is not included in the locally approved combination regimen with amivantamab (regardless of whether it is part of an interventional study). One cycle of platinum-based chemotherapy (for example, carboplatin-pemetrexed) is permitted prior to the first dose of amivantamab in a 1L while awaiting biopsy results
- Participant has received prior treatment with amivantamab in a clinical trial or for compassionate use
- Participants who are not receiving amivantamab but are being treated with a biosimilar or a non-original biologic agent
- Participants with conditions listed in the contraindications of the SmPC for amivantamab or other agents essential for the applicable amivantamab-containing treatment regimen (lazertinib/ platinum/ pemetrexed)
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
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Cohort B: Amivantamab with carboplatin and pemetrexed
Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR TKI, who received at least 1 dose of amivantamab in combination with carboplatin and pemetrexed, as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study. |
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Cohort C: Amivantamab and lazertinib
Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations (first-line therapy) who received at least 1 dose of amivantamab in combination with lazertinib as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Real-World Time to Treatment Discontinuation (rwTTD)
Временное ограничение: Up to approximately 60 Months
|
rwTTD is defined as the time from the date of initiation of the amivantamab-containing regimen to discontinuation of the full amivantamab containing regimen for any reason, including disease progression, treatment toxicity or death. |
Up to approximately 60 Months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Real-World Progression-Free Survival (rwPFS)
Временное ограничение: Up to approximately 60 Months
|
rwPFS is defined as the time from the date of initiation of the amivantamab-containing regimen to the date of investigator-determined disease progression (radiological or clinical) or death due to any cause, whichever occurs first. |
Up to approximately 60 Months
|
|
Real-World Time to Next Treatment (rwTTNT)
Временное ограничение: Up to approximately 60 Months
|
rwTTNT is defined as the time from initiation of the amivantamab-containing regimen to start of a subsequent systemic treatment following discontinuation of the full amivantamab-containing regimen or death, whichever occurs first. |
Up to approximately 60 Months
|
|
Real-World Overall Survival (rwOS)
Временное ограничение: Up to approximately 60 Months
|
rwOS is defined as the time from the date of initiation of the amivantamab-containing regimen to the date of death from any cause or reason. |
Up to approximately 60 Months
|
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Real-World Time to Subsequent Treatment Discontinuation (rwTTD2)
Временное ограничение: Up to approximately 60 Months
|
rwTTD2 is defined as the time from initiation of the amivantamab-containing regimen to the discontinuation of the first subsequent therapy for any reason, including disease progression, treatment toxicity or death. |
Up to approximately 60 Months
|
|
Number of Participants with Adverse Events (AEs) by Severity
Временное ограничение: Up to approximately 60 Months
|
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Up to approximately 60 Months
|
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Number of Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy
Временное ограничение: Up to approximately 60 Months
|
Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy will be reported. |
Up to approximately 60 Months
|
|
Number of Participants Using Concomitant Medications
Временное ограничение: Up to approximately 60 Months
|
Participants using concomitant medications including those to manage specific AEs related to the amivantamab-containing regimen, namely infusion related reactions (IRRs), venous thromboembolism (VTEs), and dermatologic AEs including paronychia, will be reported. |
Up to approximately 60 Months
|
|
Health-Related Quality of Life (HRQoL) Assessed by SKINDEX Scale Score
Временное ограничение: Up to approximately 60 Months
|
The SKINDEX-16 measures how a participant's skin condition impacts their health-related quality of life. There are 16 questions on a 7-point scale, ranging from 0 (never bothered) to 6 (always bothered). The questionnaire is divided into 3 domains: symptoms (items 1 to 4), emotions (items 5 to 11), and functionality (items 12 to 16). An overall score is the average of the 3 domain scores. All domain scores will be linearly transformed to be in the range from 0 to 100. A score of 0 indicates that the skin condition has no impact on QoL, while a score of 100 indicates the worst possible impact. |
Up to approximately 60 Months
|
|
Quality of Life Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Items-30 Scale Score
Временное ограничение: Up to approximately 60 Months
|
The EORTC QLQ-C30 is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. |
Up to approximately 60 Months
|
|
Quality of Life Impact on Questions Regarding Reactive and Prophylactic Management of AEs Related to the Amivantamab-Containing Regimen
Временное ограничение: Up to approximately 60 Months
|
Three questions regarding reactive and prophylactic management of AEs related to the amivantamab-containing regimen will be reported. These questions cover the type of prophylactic/reactive concomitant medication recommended by the treating physician, frequency of use, and the degree of impact on daily life due to use of the respective medication. |
Up to approximately 60 Months
|
Соавторы и исследователи
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 61186372NSC4014
- 61186372NSC4014 (Другой идентификатор: Janssen Research & Development, LLC)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .