RecruitingNAINTERVENTIONAL

Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer

This study is gathering new tumour samples from people with lung cancer (both NSCLC and SCLC types) who have been treated with a type of medicine called immunotherapy, but whose cancer has started to grow again. The main goal is to create a tissue bank at Ambroise Paré hospital. Scientists will then use these samples to look closely at the cancer cells. They want to find out the exact reasons why the immunotherapy treatment stopped working for these patients. By understanding these 'molecular mechanisms', researchers hope to develop better treatments for lung cancer in the future. This research is important for improving cancer care and finding new ways to fight the disease.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

18 Aug 2020

Estimated completion

01 Aug 2027

Lung Cancer

What is this study about?

Imagine you have lung cancer and you're getting a special kind of treatment called immunotherapy, which helps your body's own defence system fight the cancer. Sometimes, after a while, the cancer starts to grow again, even with this treatment. This study is for people like you, where their immunotherapy has stopped working. Doctors in this study want to take another small sample of your tumour, almost like taking a tiny biopsy again.

The main idea is to collect these new tumour samples and store them safely. Think of it like building a library of samples. Scientists can then study these samples very carefully. They will be looking for tiny clues – changes in the cancer cells' makeup – that might explain why the immunotherapy stopped being effective. By understanding these changes, they hope to discover new ways to make immunotherapy work better or to find completely new treatments for lung cancer.

This research is not about testing a new treatment on you. Instead, it's about learning from your experience to help future patients. The information gathered from these samples will be used by researchers at the University of Paris-Saclay to dig deeper into the science of lung cancer and immunotherapy. Their aim is to pave the way for more effective treatments for everyone affected by lung cancer.

Key takeaways

This study collects tumour samples from lung cancer patients whose immunotherapy is no longer working.
The goal is to understand why treatments fail and find new solutions for the future.
Participation involves a single 'rebiopsy' procedure to take a new tumour sample.
There are no new treatments or medications involved in this research study.
Your contribution helps advance scientific knowledge for future lung cancer patients.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you must have been diagnosed with either NSCLC (non-small cell lung cancer) or SCLC (small cell lung cancer). Importantly, you must have already been receiving immunotherapy for your cancer, and your doctors must have found that your cancer has started to grow again while on this treatment.

You also need to be at least 18 years old when you agree to join the study, and you must be able to understand and sign a consent form, which explains everything about the study. This shows you agree to take part voluntarily.

There are a few reasons why you might not be able to join. For example, if you have a guardian or someone else legally managing your affairs, or if it's not possible to safely take another small sample of your tumour using a local anaesthetic (which numbs just a small area).

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.

I have been diagnosed with lung cancer (NSCLC or SCLC).
I am currently receiving or have recently received immunotherapy for my lung cancer.
My doctors have confirmed that my cancer has started to grow again while on immunotherapy.
I am 18 years old or older.
I am able to understand and sign an agreement to join the study (informed consent).
It is medically possible for me to have another small tumour sample taken.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you would do is have a 'rebiopsy'. This means doctors will take another small sample of your tumour. This is usually done with a local anaesthetic, so you shouldn't feel much pain during the procedure. The procedure itself is generally quick, but includes preparation and recovery time.

There will be no daily medication or extra visits specifically for this study beyond what your regular cancer care involves. The tumour sample will be stored for future research. Your participation effectively ends after the rebiopsy and once your sample has been successfully collected and stored. The total duration of your direct involvement would be the time it takes to complete the rebiopsy procedure and any immediate follow-up related to it.

Potential risks and benefits

The main benefit of taking part in this study is contributing to our understanding of lung cancer and immunotherapy, which could help develop better treatments for future patients. There are no direct personal medical benefits for you from participating, as this study is about collecting samples for research, not providing treatment. The risks associated with the rebiopsy are similar to any biopsy, which can include discomfort, bleeding, or a small risk of infection, although these are usually minor. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your standard medical care.

Locations (1)

Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
Verified postcode
Boulogne-Billancourt, France· Recruiting

Common questions

What is a 'rebiopsy'?

A rebiopsy means taking another small sample of your tumour after an initial one was taken, usually done to see how the cancer has changed.

Will I get a new treatment in this study?

No, this study is about collecting samples to understand cancer better, not about giving new treatments. Your medical care will continue as usual.

Why is this research important?

By studying your tumour sample, researchers hope to find out why immunotherapy stopped working, which could lead to better medicines for others in the future.

What if I change my mind after joining?

You can withdraw from the study at any time, and it will not affect your ongoing medical care or relationship with your doctors.

Who will use my tumour sample?

Your sample will be used by researchers at the University of Paris-Saclay to study lung cancer and immunotherapy.

How to find out more

Etienne Giroux Leprieur, MD, PhD

etienne.giroux-leprieur@aphp.fr +33 1 49 09 58 02 Official trial record

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