Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic… (NCT07563205) | Clinical Trial Compass
RecruitingNot Applicable
Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer
France100 participantsStarted 2025-11-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Timeframe: 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
Timeframe: 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