
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at BKM120 for people who have non small cell lung cancer that has spread. To enter the trial, your lung cancer cells must have changes to a cell signalling system called the PI3K pathway.
If non small cell lung cancer spreads to another part of your body, you may have chemotherapy. But the cancer can get worse or come back after having chemotherapy. Researchers are looking for new drugs to help people in this situation. In this trial, they are looking at a drug called BKM120.
BKM120 is a type of biological therapy that blocks the action of proteins called PI3K (a PI3K inhibitor).
PI3K proteins do a number of different things, such as sending signals to tell cancer cells to grow. This is called the PI3K pathway. In some cancers PI3K is permanently switched on (activated), which means that the cancer cells grow and reproduce uncontrollably. People taking part in this study have an activated PI3K pathway. Researchers hope that blocking PI3K proteins may help stop cancer cells from growing.
The aim of this trial is to see if BKM120 helps people who have non small cell lung cancer that has come back, despite having other treatment, and where the lung cancer cells have changes to the P13K pathway.
You may be able to enter this trial if you
As well as all the above, your cancer must have got worse despite having chemotherapy
You cannot enter this trial if you
As well as the above, you cannot join the 2nd part of the trial if you have squamous cell cancer and have already had a drug called docetaxel, or you have other types of non small cell lung cancer (non squamous) and have already had docetaxel and a drug called pemetrexed.
This international phase 2 trial will recruit about 180 people around the world.
Before you can join the trial, the researchers will test to see if your cancer cells have changes to the PI3K pathway. To do this, they need a sample of your lung cancer. They may be able to get a sample that was removed when you had surgery or a . If not, they will ask you to have a new biopsy. They will also take a blood sample.
The trial is in 2 parts. In the 1st part of the trial, everybody has BKM210 capsules. You take them by mouth once a day. The trial team will give you more information about exactly how and when to take the capsules.
In the 2nd part of the study, some people will have BKM120, some will have chemotherapy. This part of the study is randomised. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. There will be twice as many people in the BKM120 group as in the chemotherapy group.
If you have chemotherapy, you have either docetaxel or pemetrexed. Your doctor will decide which drug you have, depending on the type of non small cell lung cancer you have. In this trial, you have chemotherapy through a drip into a vein once every 3 weeks. It takes about an hour each time.
The trial team will ask you to fill out a questionnaire once every 3 weeks during treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you. If you are in the chemotherapy group and your cancer gets worse, it may be possible for you to then have BKM120. The trial doctor will discuss this with you at the time.
Depending on where the cancer is in your lung, the trial team may ask you to have another at the beginning of the trial and again if your cancer gets worse. They will also ask you to have some extra blood tests. They will use these blood and tissue samples to look for
. These are substances that can help doctors to see how well the treatment is working. They hope that finding biomarkers will help them develop tests to work out who is most likely to benefit from this treatment.
You will see the trial team and have some tests before you start treatment. The tests include
You may also have a bone scan.
During the trial treatment, you go to hospital to see the trial team every 10 days. You have regular blood tests and ECGs. You have a CT or MRI scan every 6 weeks and a MUGA or echocardiogram every 12 weeks.
At some hospitals, doctors will take extra blood samples to learn more about what happens to BKM120 in your body. This is called . If you are involved in this part of the study, you may be at the hospital for quite a few hours on a couple of days.
When you finish having treatment, you see the trial doctors again and have more tests and scans. After that, a member of the trial team will contact you every 2 months to see how you are.
As BKM120 is a new drug, there may be side effects we don’t know about yet. Possible side effects include
In earlier trials, some people taking BKM120 had such significant changes in their mood (including anxiety and depression) that they had to stop taking the drug. Researchers don’t fully understand why these changes happen and the impact they have on people. But at some hospital visits they will ask you to fill in questionnaires about how you are feeling (your mood), so they can monitor this.
The side effects of the chemotherapy drugs in this trial include tiredness (fatigue) and a drop in blood cells causing an increased risk of infection, bleeding problems and breathlessness. We have more information about the possible side effects of docetaxel and pemetrexed.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Rohit Lal
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Novartis
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”