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 biopsy
. 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 biopsy
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 biomarkers
. 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.