RecruitingOBSERVATIONAL

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

This study is checking how safe and effective a treatment called amivantamab, when given with chemotherapy, is for people with a type of lung cancer called non-small cell lung cancer (NSCLC). This specific lung cancer has certain gene changes, known as EGFR mutations. The study involves people already receiving this treatment through an early access program. Researchers want to see how long the treatment keeps the cancer from growing or getting worse. This is an 'observational' study, meaning doctors will just collect information from regular appointments without asking anyone to have extra tests or procedures. It helps us learn more about this treatment in real-life situations.

At a glance

Status

Recruiting

Sponsor

GFPC Investigation

Enrolment target

100

Start

19 Nov 2025

Estimated completion

19 Nov 2027

Non-Small Cell Lung Cancer Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer NSCLC Non Small Cell Lung Carcinoma NSCLC EGFR EGFR Exon 20 Insertion Mutation EGFR Exon 19 Deletion Mutation EGFR Exon 21 Mutation

What is this study about?

Imagine you have a type of lung cancer called non-small cell lung cancer, and doctors have found specific changes in your cancer cells’ genes, called EGFR mutations. These mutations can make the cancer grow. Researchers are interested in a treatment that combines chemotherapy (which is a common cancer medicine) with a newer drug called amivantamab.

This study is designed to understand how well this treatment combination works and if it's safe for people like you in their everyday lives. It's not a study where you get a new medicine; instead, it looks at people who are already receiving amivantamab and chemotherapy because their doctor decided it was the best course of action. This is happening through what's called an 'early access program', which means the treatment is available to some patients before it's widely approved.

There are two main groups in the study, depending on the exact gene change in their cancer and whether they've had other treatments. The main goal is to find out how long this treatment keeps the cancer from growing or getting worse. It's like collecting a puzzle, using information from many patients to get a clearer picture of how well a particular treatment works for different people and to ensure treatment pathways are as effective as possible.

Key takeaways

This study helps understand a lung cancer treatment in real life.
It focuses on people with specific gene changes in their lung cancer.
Participation means sharing existing medical information, no extra tests.
It aims to see how long the cancer is kept under control.
Results could help improve future treatments for others.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. You must also have metastatic non-small cell lung cancer, which means the cancer has spread, and it needs to have specific EGFR gene changes.

Specifically, one group includes people whose cancer has an EGFR exon 20 insertion mutation and who are getting amivantamab with platinum-based chemotherapy as their very first treatment for advanced cancer. The other group includes people whose cancer has an EGFR exon 19 or exon 21 mutation and who are getting amivantamab with platinum-based chemotherapy after already being treated with another drug called osimertinib (which may or may not have been with chemotherapy).

Importantly, you must already be receiving this combination treatment through an early access program and be cared for by your usual cancer doctor in France. You also need to agree to your medical information being used for research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer with specific EGFR gene changes?
Are you currently receiving amivantamab with chemotherapy through an early access program?
Are you being treated by a cancer specialist in France?
Are you comfortable with your medical information being used for research?

Answer every question to see your result.

What does participation involve?

If you are already receiving amivantamab and chemotherapy for your lung cancer through an early access program, your participation in this study is very straightforward. You won't have to do anything differently from your normal medical care. You will continue to see your usual cancer doctor as planned, and they will collect your medical information from your appointments. This information will then be used for the study. There are no extra tests, procedures, or hospital visits required because of the study. The researchers will simply gather details from your existing medical records between March 2024 and October 2025.

Potential risks and benefits

Because this is an 'observational' study, meaning you are already receiving the treatment as part of your normal care, there are no additional risks from participating. You won't have any extra tests or procedures. The potential benefit is that the information gathered from your regular medical care will help doctors better understand how well this treatment works in real life for people with your type of lung cancer. This could lead to better care for others in the future. You always have the right to say no to your information being used for research, and this won't affect your medical care in any way.

Locations (16)

CH du Pays d Aix - Service des Maladies Respiratoires
Verified postcode
Aix-en-Provence, France· Recruiting
APHP Hôpital Avicennes
Verified postcode
Bobigny, France· Recruiting
Hôpital Louis Pradel
Verified postcode
Bron, France· Active not recruiting
Pneumologie Centre François Baclesse
Verified postcode
Caen, France· Active not recruiting
Pneumologie Centre Hospitalier Intercommunal de Créteil
Verified postcode
Créteil, France· Recruiting
Hôpital A. Mignot
Verified postcode
Le Chesnay, France· Recruiting
Pneumologie Hôpital Calmette
Verified postcode
Lille, France· Recruiting
Pneumologie Hôpital privé Jean Mermoz
Verified postcode
Lyon, France· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
Hôpital Nord
Verified postcode
Marseille, France· Recruiting
CHRU de Nancy
Verified postcode
Nancy, France· Active not recruiting
Centre Antoine Lacassagne
Verified postcode
Nice, France· Active not recruiting

Common questions

What is an 'observational study'?

It means doctors will simply collect information from your regular medical visits and records. You won't have to do anything differently or have extra tests just for the study.

What is 'amivantamab'?

Amivantamab is a specific type of medicine used to treat certain lung cancers that have particular gene changes. It works differently from traditional chemotherapy.

What are 'EGFR gene mutations'?

EGFR gene mutations are specific changes in the genetic code of your lung cancer cells. They can make the cancer grow and are important for choosing the right treatment.

Will I get new treatment if I join this study?

No, this study is for people already receiving amivantamab and chemotherapy as part of their regular care. You won't start new treatment because of this study.

Will my privacy be protected if I participate?

Yes, your personal medical information will be handled carefully and used for research purposes only, keeping your identity private.

How to find out more

Prof. Laurent Greillier

a.boucheix@g-f-p-c.org +33 4 73 98 39 86 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.