A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung Cancer (BR31)
This important study, called BR31, is testing a new treatment called durvalumab (also known as MEDI4736) for people who have already had surgery to remove a type of lung cancer called non-small cell lung cancer (NSCLC). Doctors want to find out if this drug can help prevent the cancer from returning. They are particularly interested in patients whose cancer has a certain marker called PD-L1, and who don't have other specific genetic changes (EGFR/ALK-). Half the patients will receive durvalumab, and the other half will receive a dummy drug (placebo) to fairly compare the results. The main goal is to see how long people stay cancer-free, and they will also look at overall survival, quality of life, and any side effects.
At a glance
What is this study about?
Imagine you've had surgery to remove a type of lung cancer called non-small cell lung cancer, which is the most common kind. Even after surgery, there's a chance the cancer could come back. This study, known as BR31, is designed to see if a new drug called durvalumab (also called MEDI4736) can help prevent this.
Durvalumab is a type of medicine that helps your body's own immune system fight cancer. The researchers want to know if giving this drug after surgery can make a difference. They are particularly focusing on people whose cancer cells show a certain feature called PD-L1, which can tell doctors how likely a cancer is to respond to this type of treatment. They are also looking at patients whose cancer *doesn't* have changes in the EGFR or ALK genes.
By comparing durvalumab to a dummy drug (placebo), the study aims to understand if this new treatment can help people stay cancer-free for longer and improve their overall health. This kind of research is really important because it helps doctors find better ways to treat lung cancer and improve the lives of patients.
Key takeaways
- This study is testing a new drug (durvalumab) to stop lung cancer from returning after surgery.
- It focuses on specific types of non-small cell lung cancer based on certain markers.
- Participants will receive either the study drug or a dummy drug (placebo).
- The main aim is to see if the drug helps people stay cancer-free for longer.
- Both men and women aged 18 and over can be considered.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 or older.
You would have recently had surgery to completely remove a non-small cell lung cancer that was at certain stages (IB, II, or IIIA). The doctors will also check specific features of your cancer, such as how much PD-L1 it has and whether it has particular genetic changes (EGFR or ALK).
Both men and women can take part in this study. Your medical team will carefully review your health records to make sure you meet all the necessary requirements.
- Are you 18 years old or older?
- Have you recently had surgery to completely remove non-small cell lung cancer?
- Was your cancer at stage IB (if 4cm or larger), II, or IIIA?
- Has your doctor confirmed specific genetic markers (PD-L1 positive, EGFR/ALK negative) for your cancer?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either the study drug, durvalumab, or a placebo (a dummy drug that looks like the real thing but has no active medicine). Neither you nor your doctor will know which one you're receiving – this helps ensure the results are fair. You'll receive this treatment over a period of time, likely through injections or infusions.
Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and see how the treatment is working. Doctors will carefully look for any side effects and track if your cancer stays away. This will involve ongoing follow-up for several years, even after you stop receiving the study drug, to see the long-term effects.
Potential risks and benefits
Locations (8)
- —Bulgaria
- —Spain
- —Romania
- —Netherlands
- —France
- —Poland
- —Hungary
- —Italy
Common questions
What is durvalumab?
Durvalumab is a medicine that helps your body's own immune system fight cancer cells. It's designed to help prevent lung cancer from coming back after surgery.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real drug but contains no active medicine. It's used in studies to fairly compare the new drug to no active treatment.
Why are doctors looking at 'PD-L1'?
PD-L1 is a marker on cancer cells. Knowing how much PD-L1 a cancer has can help doctors predict if treatments like durvalumab are likely to work.
What does 'non-small cell lung cancer' mean?
Non-small cell lung cancer is the most common type of lung cancer. This study is for people who have had surgery for it at certain stages.
Will I know if I'm getting the real drug or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know whether you're receiving durvalumab or the placebo. This helps make the study results as accurate as possible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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