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RecruitingNAINTERVENTIONAL

Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion

This research aims to understand why the treatment amivantamab might stop working for people with advanced non-small cell lung cancer (NSCLC) who have a particular gene change called an EGFR exon 20 insertion. By studying blood and, if possible, tumour samples when the cancer progresses, researchers hope to discover the reasons for this resistance. This knowledge could help doctors better predict how future treatments might work and develop new strategies to keep the cancer under control for longer. Taking part involves providing blood samples and, if available, a tumour sample.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Groupe Francais De Pneumo-Cancerologie
Enrolment target
30
Start
15 Jan 2024
Estimated completion
30 Jul 2026

What is this study about?

This study, called RESAMEX, is designed to understand something very important for people living with a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically when they have a certain gene change called an EGFR exon 20 insertion. When you have this type of cancer, you might be treated with a medicine called amivantamab.

Over time, some treatments can stop working as well as they once did. This study wants to find out *why* this happens with amivantamab. By looking closely at samples from patients when their cancer starts to grow again despite treatment, the researchers hope to discover the biological reasons behind this 'resistance'. Think of it like trying to understand how a lock changes so that the original key no longer works.

The information gathered from this study is really important. If doctors can understand why a treatment stops being effective, they might be able to predict which other treatments would work best next, or even help guide the development of new and more effective medicines in the future. It’s all about helping patients with this specific type of lung cancer have better outcomes.

Key takeaways

  • This study investigates why amivantamab stops working for certain lung cancer patients.
  • It focuses on advanced non-small cell lung cancer with an EGFR exon 20 insertion.
  • Participation involves providing blood and, if possible, tumour samples when cancer progresses.
  • The goal is to understand resistance and improve future treatment strategies.
  • There are no direct benefits to participants, but information helps future patients.
  • This specific study is based in France.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have advanced non-small cell lung cancer (NSCLC) with a specific gene change called an EGFR exon 20 insertion. You must also be currently receiving amivantamab as your only cancer treatment within France under a special access program.

Your doctor must have confirmed that your cancer has started to progress while on amivantamab. You also need to be covered by the French National Health Insurance or a similar private insurance.

Unfortunately, you can't join if you're taking amivantamab alongside another cancer treatment, or if you're not able to provide the necessary blood samples when your cancer progresses.

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.

  1. Are you 18 years old or older?
  2. Do you have advanced non-small cell lung cancer with an EGFR exon 20 insertion?
  3. Are you currently receiving amivantamab as your only cancer treatment?
  4. Has your doctor confirmed that your cancer is progressing on amivantamab?
  5. Are you willing to provide blood samples and, if possible, a tumour sample at progression?
  6. Are you enrolled in the French National Health Insurance or a third-party payer?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is to have a chat with the study team and read through all the information. If you're happy to proceed, you'll be asked to sign a consent form, which means you understand and agree to the study procedures.

The main part of your involvement happens if and when your doctor confirms that your cancer is growing again while you're on amivantamab. At this point, the study team will take a small amount of blood from you. This is a routine blood draw, usually two small tubes (about 20ml in total).

If it's possible and your doctor agrees, a small sample of your tumour tissue might also be collected at the same time. These samples will then be sent to a specialist lab for detailed analysis to look for changes in your cancer cells. There are no extra hospital visits needed for this study; the samples are collected during your usual medical appointments. The study continues for as long as needed to collect these samples after your disease has progressed on amivantamab.

Potential risks and benefits

Taking part in this study could help future patients by providing valuable information about how lung cancer treatments work and why they sometimes stop being effective. However, there are no immediate direct benefits to you as an individual patient, as your treatment will not change based on this research. The main risk involves the blood tests, which are generally safe but may cause minor bruising or discomfort. If a tumour tissue sample is taken, there are very small risks associated with that procedure, which your doctor will explain. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (18)

  • Oncologie Polyclinique Bordeaux Nord Aquitaine
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • Centre Hospitalier du Morvan
    Verified postcode
    Brest, France· Recruiting
  • Pneumologie Centre Hospitalier Intercommunal de Créteil
    Verified postcode
    Créteil, France· Recruiting
  • Oncologie, CLCC Dijon
    Verified postcode
    Dijon, France· Not yet recruiting
  • Pneumologie, CHU Grenoble
    Verified postcode
    Grenoble, France· Recruiting
  • Pneumologie CH
    Verified postcode
    Le Mans, France· Not yet recruiting
  • Oncologie thoracique Hôpital Nord
    Verified postcode
    Marseille, France· Recruiting
  • Oncologie, Centre Antoine Lacassagne
    Verified postcode
    Nice, France· Withdrawn
  • Oncologie Institut Curie
    Verified postcode
    Paris, France· Not yet recruiting
  • Hôpital Cochin
    Verified postcode
    Paris, France· Recruiting
  • Pneumologie, Hôpital Tenon
    Verified postcode
    Paris, France· Recruiting
  • Pneumologie Centre Hospitalier
    Verified postcode
    Pau, France· Not yet recruiting

Common questions

What is an EGFR exon 20 insertion?

It's a specific change or 'mutation' in a gene within your cancer cells that makes them grow. It's important because it guides which treatments might work best.

What is amivantamab?

Amivantamab is a medication used to treat certain types of advanced non-small cell lung cancer, particularly when it has the EGFR exon 20 insertion.

Why do you need blood and tissue samples?

We use these samples to look for changes in your cancer’s genes. This helps us understand why the amivantamab treatment might have stopped working.

Will taking part change my cancer treatment?

No, this study is for research only. Your current and future cancer treatments will be decided by your medical team and won't be affected by your participation in this study.

Is this study happening in the UK?

No, this particular study is currently taking place in France for patients receiving amivantamab under their special access programs.

How to find out more

Laurent GRELLIER

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

Interested in taking part?

Register your interest

Share your details and the research team for "Mechanisms of Resistance to Amivantamab in Patients With NSC…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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