Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
This study, called BioEXALK, is for people in France with advanced non-small cell lung cancer that has a specific change in the ALK gene. Participants are already taking part in another study called EXPLORE ALK and are being treated with new generations of ALK inhibitor medicines. Researchers want to understand more about the ALK-rearranged cancer itself, and how it responds to these treatments. They will do this by looking closely at samples of cancer tissue taken at diagnosis and if the cancer progresses, as well as blood samples. The aim is to find out why these cancers behave the way they do and to help develop even better treatments in the future.
At a glance
What is this study about?
Imagine your body as having tiny instruction manuals called genes. In some lung cancers, one of these instruction manuals, called the ALK gene, has a mistake or rearrangement. This particular type of lung cancer is called ALK-rearranged non-small cell lung cancer. This study is designed to help us learn more about how these specific cancers work in people who are already being treated with new, targeted medicines for this condition.
Researchers want to understand the unique features of these cancer cells. They will do this by looking at tissue samples taken when the cancer was first diagnosed and again if it progresses. They will also look at blood samples. By examining these samples very closely, they hope to find out more about the ALK gene change itself, and any other changes that might be happening in the cancer cells that could help explain why some treatments work better than others, or why the cancer might become resistant to treatment over time.
The information gathered from this study is very important. It will help doctors and scientists gain a deeper understanding of ALK-rearranged lung cancer. This knowledge can then be used to develop more effective treatments and improve the care for people living with this type of cancer in the future.
Key takeaways
- This study helps understand ALK-rearranged lung cancer.
- It uses existing tissue and blood samples, not new treatments.
- Participation will not change your current medical care.
- Your contribution helps future patients with this cancer.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must have advanced non-small cell lung cancer that has a specific ALK gene change and isn't suitable for surgery or radiotherapy that aims to cure it. You must also be at least 18 years old and already be part of another study called EXPLORE ALK. You will also need to be taking a new generation ALK inhibitor medicine as your first treatment.
Importantly, for the study, doctors will need to have a sample of your cancer tissue from when you were first diagnosed. You'll also need to be willing to provide blood samples at different times during the study. You're not able to join if you don't want to take part or if you are under a guardianship order.
This study is open to both men and women and is specifically for people in France who are covered by their national health insurance or a third-party payer.
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.
- Do I have advanced non-small cell lung cancer with an ALK gene change?
- Am I already part of the EXPLORE ALK study?
- Am I currently taking a new ALK inhibitor medicine as my first treatment?
- Is my cancer tissue sample from diagnosis available?
- Am I willing to provide blood samples at different times?
What does participation involve?
If you decide to take part in this study, you will continue with your usual medical care, including taking your prescribed ALK inhibitor medicine. The main part of your involvement will be providing samples for analysis. Researchers will use the cancer tissue sample that was taken when you were first diagnosed.
Throughout the study, you will also be asked to provide blood samples, typically at three different times: when you join, at your first review appointment after starting treatment, and if your cancer starts to grow again. If another tissue sample is taken as part of your standard care if the cancer progresses, this may also be used for analysis. There are no extra hospital visits specifically for this study beyond your regular check-ups. The samples collected will be sent to specialized labs for detailed examination.
Potential risks and benefits
Locations (46)
- Pneumologie CHU Félix GuyonVerified postcodeSaint-Denis, France· Recruiting
- Centre Hospitalier d'Aix en ProvenceVerified postcodeAix-en-Provence, France· Not yet recruiting
- Pneumologie CHUVerified postcodeAmiens, France· Not yet recruiting
- Centre Hospitalier UniversitaireVerified postcodeAngers, France· Not yet recruiting
- Centre Hospitalier d'AnnecyVerified postcodeAnnecy, France· Recruiting
- Centre Hospitalier du MorvanVerified postcodeBrest, France· Recruiting
- Centre François BaclesseVerified postcodeCaen, France· Not yet recruiting
- Pneumologie CH Métropole SavoieVerified postcodeChambéry, France· Recruiting
- Oncologie CLCC Jean PerrinVerified postcodeClermont-Ferrand, France· Not yet recruiting
- Centre Hospitalier Intercommunal de CréteilVerified postcodeCréteil, France· Recruiting
- Pneumologie CH Eure-SeineVerified postcodeÉvreux, France· Recruiting
- Pneumologie CHD VendéeVerified postcodeLa Roche-sur-Yon, France· Recruiting
Common questions
What is the ALK gene?
It's a specific gene in your body. In some lung cancers, this gene has a change that makes the cancer grow.
What is an ALK inhibitor?
These are special medicines designed to target and block the effects of the changed ALK gene, helping to slow or stop cancer growth.
Will I take a new medicine in this study?
No, you will be taking medicines that are already approved. This study is about understanding the cancer itself, not testing a new drug.
How many times will I give blood?
You'll be asked to give blood samples three times: at the start, at your first treatment review, and if your cancer progresses.
What happens to my samples?
They will be sent to special labs for detailed testing to understand your cancer's unique features.
How to find out more
Florian GUISIER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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