A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting

Официальное название

Prospective, Multi Country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Approved Amivantamab-containing Regimens Under Standard Clinical Practice

Обзор

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).

Первичные конечные точки

• Real-World Time to Treatment Discontinuation (rwTTD) [Срок оценки: Up to approximately 60 Months]

Вторичные конечные точки (10)

• Real-World Progression-Free Survival (rwPFS) [Срок оценки: Up to approximately 60 Months]
• Real-World Time to Next Treatment (rwTTNT) [Срок оценки: Up to approximately 60 Months]
• Real-World Overall Survival (rwOS) [Срок оценки: Up to approximately 60 Months]
• Real-World Time to Subsequent Treatment Discontinuation (rwTTD2) [Срок оценки: Up to approximately 60 Months]
• Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: Up to approximately 60 Months]
• Number of Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy [Срок оценки: Up to approximately 60 Months]
• Number of Participants Using Concomitant Medications [Срок оценки: Up to approximately 60 Months]
• Health-Related Quality of Life (HRQoL) Assessed by SKINDEX Scale Score [Срок оценки: 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 [Срок оценки: Up to approximately 60 Months]
• Quality of Life Impact on Questions Regarding Reactive and Prophylactic Management of AEs Related to the Amivantamab-Containing Regimen [Срок оценки: Up to approximately 60 Months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 27 центров

• Ospedale San Giuseppe Moscati di Avellino — Avellino
• Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II — Bari
• ASST Papa Giovanni XXIII Bergamo — Bergamo
• ASST Spedali Civili Brescia — Brescia
• Istituto di Candiolo, IRCCS — Candiolo
• PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania — Catania
• Azienda Ospedaliera Pugliese Ciaccio Catanzaro — Catanzaro
• Ospedale Policlinico San Martino IRCCS — Genova
• … и ещё 19 центров

Германия · 19 центров

• MVZ am Klinikum Aschaffenburg Onkologie — Aschaffenburg
• Evangelisches Klinikum Bethel — Bielefeld
• Augusta Kliniken Bochum Hattingen — Bochum
• Klinikum Chemnitz gGmbH — Chemnitz
• Haematologie u Onkologie Koeln MV Zentrum — Cologne
• Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim — Cologne
• Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung — Essen
• Universitaetsklinikum Essen — Essen
• … и ещё 11 центров

Испания · 9 центров

• Hosp Reina Sofia — Córdoba
• Hosp. de Jerez de La Frontera — Jerez de la Frontera
• Hosp. Univ. Lucus Augusti — Lugo
• Hosp Regional Univ de Malaga — Málaga
• Complexo Hosp. Univ. de Ourense — Ourense
• Hosp. Univ. Son Espases — Palma de Mallorca
• Hosp. Clinico Univ. de Santiago — Santiago de Compostela
• Hospital Universitario Virgen Rocio — Seville
• … и ещё 1 центр

Великобритания · 8 центров

• Royal United Hospital — Bath
• Velindre Hospital — Cardiff
• Eastbourne District General Hospital — Eastbourne
• Royal Surrey County Hospital NHS Trust — Guildford
• New Cross Hospital — Heath Town
• Royal Marsden Hospital — London
• The Christie NHS Foundation Trust Christie Hospital — Manchester
• Royal Marsden Hospital (Sutton) — Sutton

Бельгия · 7 центров

• UZ Brussel — Brussels
• UZ Antwerpen — Edegem
• Jessa Ziekenhuis — Hasselt
• Az Groeninge — Kortrijk
• Chu Helora Hospital La Louviere Site Jolimont — La Louvière
• CHU de Liege — Liège
• Vitaz — Sint-Niklaas

Чехия · 4 центра

• Fakultni nemocnice Brno — Brno
• Fakultni nemocnice Hradec Kralove — Hradec Králové
• Fakultni nemocnice Olomouc — Olomouc
• Fakultni Thomayerova nemocnice — Prague

Австрия · 3 центра

• University Hospital Graz — Graz
• Klinikum Klagenfurt am Worthersee — Klagenfurt
• Landeskrankenhaus Hochzirl Natters — Natters

Израиль · 3 центра

• Rabin Medical Center — Petah Tikva
• Sheba Medical Center — Ramat Gan
• Assuta MC — Tel Aviv

Идентификаторы

NCT: NCT07230691 · 61186372NSC4014 · 61186372NSC4014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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