Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer NSCLC, Non Small Cell Lung Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program
Overview
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.
Primary outcome measures
- Investigator Progression Free Survival (Investigator PFS) [Time frame: 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) [Time frame: 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]
Secondary outcome measures (12)
- Baseline Clinical Characteristics [Time frame: At Baseline visit, on a maximum period of 12 months]
- Overall Survival (OS) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: From the combination treatment start date up to a 2-year-period maximum]
- Treatment duration [Time frame: From the combination treatment start date up to a 2-year-period maximum]
- Reasons for discontinuation [Time frame: From the combination treatment start date up to a 2-year-period maximum]
- Site of progression after treatment combination administration [Time frame: 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 [Time frame: From date of first lung cancer treatment administration for a 2-year-period maximum]
- Post-progression Progression Free Survival (ppPFS) [Time frame: 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 [Time frame: 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) [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 16 centers
- 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
- … and 8 more centers
Identifiers
NCT: NCT07563205 · OMAE GFPC 02-2024 · CNRIPH National number · CPP