Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer

Официальное название

Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program

Обзор

The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations. The study includes two groups of people: * Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program. * Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program. The main question the study wants to answer is: How long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people? People already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025. No extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.

Первичные конечные точки

• Investigator Progression Free Survival (Investigator PFS) [Срок оценки: From the date of first dose of combination treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum]
• Independent Panel Progression Free Survival (Independent Panel PFS) [Срок оценки: From the date of first dose of treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum]

Вторичные конечные точки (12)

• Baseline Clinical Characteristics [Срок оценки: At Baseline visit, on a maximum period of 12 months]
• Overall Survival (OS) [Срок оценки: Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum]
• Investigator Objective Response Rate (Investigator ORR) [Срок оценки: From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum]
• Independent Panel Objective Response Rate (Independent Panel ORR) [Срок оценки: From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum]
• Adverse events [Срок оценки: From the combination treatment start date up to a 2-year-period maximum]
• Treatment duration [Срок оценки: From the combination treatment start date up to a 2-year-period maximum]
• Reasons for discontinuation [Срок оценки: From the combination treatment start date up to a 2-year-period maximum]
• Site of progression after treatment combination administration [Срок оценки: Assessed at each tumor evaluation scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum]
• Description of Post-progression type of treatments [Срок оценки: From date of first lung cancer treatment administration for a 2-year-period maximum]
• Post-progression Progression Free Survival (ppPFS) [Срок оценки: Assessed at each site visit scheduled as per local practice, from initiation of the first post-progression treatment until documented progression, death, end of treatment, or study completion, whichever occurs first, for a 2-year-period maximum]
• Treatment outcomes by patients' baseline and disease characteristics [Срок оценки: Assessed at each site visit scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum]
• Investigator Central Nervous System Objective Response Rate (Investigator CNS ORR) [Срок оценки: From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum]

Критерии участия

Критерии включения

• Patient over 18 years old
• Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.
• Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.
• Patient covered by the French National Health Insurance system or by an approved third-party payer
• Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)

Критерии исключения

• Patient placed under legal guardianship or subject to a protective legal measure
• Patient who explicitly refuses the collection or use of their personal data for research purposes
• Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 16 центров

• CH du Pays d Aix - Service des Maladies Respiratoires — Aix-en-Provence
• APHP Hôpital Avicennes — Bobigny
• Hôpital Louis Pradel — Bron
• Pneumologie Centre François Baclesse — Caen
• Pneumologie Centre Hospitalier Intercommunal de Créteil — Créteil
• Hôpital A. Mignot — Le Chesnay
• Pneumologie Hôpital Calmette — Lille
• Pneumologie Hôpital privé Jean Mermoz — Lyon
• … и ещё 8 центров

Идентификаторы

NCT: NCT07563205 · OMAE GFPC 02-2024 · CNRIPH National number · CPP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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