A trial of BKM120 for advanced non small cell lung cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Closed

Phase:

Phase 2

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.

Who can enter

You may be able to enter this trial if you

Have non small cell lung cancer that has spread to other parts of your body and the PI3K pathway is activated (the trial team will test for this)
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Are willing to use reliable contraception during the trial and for 3 months after if there is any chance you or your partner could become pregnant
Are at least 18 years old

As well as all the above, your cancer must have got worse despite having chemotherapy

If your cancer is squamous cell cancer, you can have had only had 1 type of chemotherapy that included a platinum drug for cancer that has spread or
If you have another type of non small cell lung cancer, you can have had 1 or 2 other types of treatment for cancer that has spread – if your cancer was tested for a gene change that affects a growth factor called EGFR this must include at least 1 drug called a tyrosine kinase inhibitor such as erlotinib or gefitinib

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord and has not been treated or is causing symptoms (you can take part if you had treatment for cancer spread to your brain at least 2 weeks ago, it is not causing symptoms and if you are taking steroids, you have been on a low, stable dose for at least 2 weeks)
Have already had a drug that blocks PI3K
Are currently having any other type of cancer drug
Have not recovered from the side effects of other cancer drugs (apart from hair loss) unless they are very mild
Have had radiotherapy in the last 4 weeks, or earlier if you have not fully recovered from any side effects
Have had surgery in the last 4 weeks, or earlier if you have not fully recovered
Have had mental health problems such as severe depression or anxiety
Have diabetes that is not well controlled with medication
Have had any heart problems that are a cause for concern or take other medication that can affect your heart rhythm – the trial doctors can advise you about this
Have any problems with your digestive system that could affect how you absorb tablets
Have been taking steroids or other medication that damps down your immune system (you can take part if you use steroid creams, inhalers or eye drops)
Take drugs that can affect a group of enzymes called CYP3A – the trial doctors can explain this
Take a blood thinning medicine called warfarin or a similar drug
Have had any other type of cancer in the last 5 years apart from non melanoma skin cancer or cervical cancer that was completely removed with surgery
Have any other serious medical condition that the trial doctors think could affect your taking part
Are known to be HIV positive
Are pregnant or breastfeeding

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.

Trial design

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 Open a glossary item . 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 Open a glossary item 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.

Hospital visits

You will see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood and urine tests
Heart trace (ECG )
Heart ultrasound (echocardiogram ) or MUGA scan
CT scan or MRI scan

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 pharmacokinetics Open a glossary item . 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.

Side effects

As BKM120 is a new drug, there may be side effects we don’t know about yet. Possible side effects include

High blood sugar
Skin rash and itching
Sore mouth
Tiredness (fatigue)
General discomfort
Diarrhoea or constipation
Tummy (abdominal) pain
Changes to your liver
Feeling or being sick
Loss of appetite
Changes to your mood, such feeling anxious, depressed or irritable

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.