
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at 2 new drugs called dabrafenib and trametinib to treat non small cell lung cancer. It is for people who have non small cell lung cancer (NSCLC) that has spread to another part of the body (advanced non small cell lung cancer).
Doctors can treat advanced NSCLC with chemotherapy. This can work for a while but sometimes the cancer begins to grow again. So doctors are always looking for new ways to improve treatment.
In a small number of people who have NSCLC there are changes in the genes called BRAF and MEK. These genes makes proteins that affects how cancer cells divide and grow.
Dabrafenib and trametinib are both a type of biological therapy. They are cancer growth blockers. They stop signals that cancer cells use to divide and grow.
We know from research that dabrafenib may help people with other cancers that have a particular gene change (mutation). The researchers think it may help people with NSCLC that has the same gene change.
We know from research that trametinib alongside dabrafenib may work better than dabrafenib only. The researchers think that this may be the case for people with NSCLC.
The aims of this study are to find out
You may be able to enter this trial if
You cannot enter this trial if you
This is an international phase 2 trial. It will recruit 100 people. There are 2 groups in this trial.
The researchers have enough people in group A. So everyone joining the trial will now go into group B.
Dabrafenib is a tablet. You take it twice a day. Trametinib is a tablet. You take it once a day.
You continue treatment as long as the side effects aren’t too bad and it is still helping you.
If you agree to take part in this study, the researchers will ask for a piece of tissue taken when you had surgery to remove your cancer or a sample () taken. This is to test for a particular gene change in your lung cancer cells. If there isn’t enough tissue to do this, or your doctor thinks they need another biopsy, they will talk to you about it. You must agree to this if you want to take part in this trial.
The researchers will also ask for blood samples taken before you start treatment and if your cancer gets worse. They will ask for a skin sample if you develop cancer on your skin. They will use these samples to look for substances in your body () that may help to show how your cancer is going and how well treatment is working. If you don’t want to give these samples for this study, you don’t have to. You can still take part in the trial.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor every 3 weeks for a physical examination and blood tests. You have the other tests regularly during treatment.
After treatment, every 3 months you either see the doctor or are contacted by the research team to see how you are.
Dabrafenib and trametinib are new drugs and there may be side effects we don’t know about yet. The most common side effects reported include
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Sanjay Popat
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.