Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A study looking at adding a biological therapy to radiotherapy for non small cell lung cancer
This study is looking at how well a new biological therapy called BKM120 works alongside radiotherapy for non small cell lung cancer.
This study is supported by Cancer Research UK.
More about this trial
Doctors usually treat non small cell lung cancer with radiotherapy. Researchers in this study want to find out if adding a type of biological therapy will make cancer cells more sensitive to radiotherapy, meaning that more cancer cells are killed.
BKM120 is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The people taking part in this study will have BKM120 in different doses, along with a 5 day course of radiotherapy. After finding the best dose of BKM120 to give alongside radiotherapy, the researchers will test the chosen dose in another group of people.
The aim of this study is to see if adding BKM120 to radiotherapy is safe and works well.
Who can enter
You may be able to enter this study if you
- Have non small cell lung cancer
- Have had a scan in the last 8 weeks that shows an area of cancer in your lung or chest that is not curable
- Need to have radiotherapy to control symptoms
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood tests
- Are able to swallow and keep down medicine
- Would be willing to use a type of reliable contraception approved by the study team, if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this study if you
- Have cancer spread to your brain or spinal cord that is not well controlled with medication and causing symptoms despite treatment
- Have had chemotherapy or biological therapy in the last 4 weeks
- Have ever had radiotherapy to your chest, or radiotherapy to anywhere else in the last 28 days
- Have had major surgery in the last 14 days
- Have taken any trial medication in the last 28 days
- Are still having moderate to severe side effects from any cancer treatment (if you have hair loss, you may still be able to take part)
- Are taking any medication that affects the CYP3A4 enzyme – you can ask your doctor about this
- Have already taken a drug similar to the study drug – you can ask your doctor about this
- Are sensitive or allergic to any of the ingredients of the study drug – you can ask your doctor about this
- Have poorly controlled
- Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 3 years ago
- Have a mental health condition
- Have moderate to severe depression or anxiety
- Have ever thought about killing yourself, or have tried this
- Have any digestive system problem that could affect how well your body can take in and use the study drug
- Have hepatitis B, hepatitis C or HIV
- Have serious heart problems
- Are pregnant or breastfeeding
- Have any other condition that would make you unwell if you took part, or affect the results of the study – you can ask your doctor about this
This study will recruit about 30 people.
Everyone will have 5 doses (fractions) of radiotherapy. You have treatment once a day for a week. Everyone will also take BKM120. The dose and how long you take it for depends on when you join the study.
The first patients taking part will have the lowest dose of BKM120. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
When team have found the best dose to give, they will recruit 6 more people to take this dose. The team call this group the ‘dose expansion group’.
If scans from those who have taken part so far do not show that BKM120 has made the lung cancer more sensitive to radiotherapy, the team will then recruit people to join the next group, group 4. If you join group 4 you have the same dose as those in the dose expansion group, but take it for longer before your radiotherapy.
If you are in the dose escalation study or the dose expansion group, you start taking BKM120 a week before you start radiotherapy and continue until you finish radiotherapy. If you are in group 4, you start taking the drug 3 weeks before your radiotherapy and continue until you finish radiotherapy.
You take BKM120 capsules each morning with a glass of water. You take them an hour after a light breakfast, and you should not eat for 2 hours afterwards. You should not eat Seville oranges, or grapefruit, or drink their juices, from 7 days before you start taking BKM120, until you finish the course of capsules. You can drink normal orange juice. You record on a diary card when you took each dose.
The PET-CT scan uses a mildly radioactive dye to show up oxygen in your cancer. The team will be able to see if BKM120 makes the cancer cells more sensitive to radiotherapy by changing their oxygen levels. During the scan the team will take more blood tests, to help them better understand the scan pictures.
If you are in the dose escalation or dose expansion study, you take part in the study for about 8 weeks. You see the doctor 5 times during this time for
- A physical examination
- Blood pressure and pulse check
- Weight check
- Blood tests
You will also have a PET-CT scan and CT scan the day before starting BKM120, and again a week later.
If you join group 4, you take part in the study for about 10 weeks. You see the doctor 7 times during this time. You have the same scans as above, but have them the day before starting BKM120 and then 3 weeks later.
Your PET-CT scan appointment will last about 5 hours. This is because the dye needs to work its way round your body before the scan. You have the CT scan on the same day.
The scans and 2 of the doctor appointments are extra to what you would have if you were not in the study.
The radiotherapy you have in the study is the same as what you would have if you were not taking part. Side effects include
Adding BKM120 to radiotherapy may make these side effects worse, but the team do not think they will be severe.
The most common side effects of BKM120 include
- Loss of appetite
- Feeling or being sick
- Severe tiredness (fatigue)
- High blood sugar levels
- Tummy pain
- Feeling low in mood
- Getting sunburnt more easily
You will have a small amount of extra radiation from the scans in this study. The team think that any health risks to you are very low, as the dose you will get is very small compared to radiotherapy.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Geoff Higgins
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Oxford Cancer Imaging Centre
University of Oxford
This is Cancer Research UK trial number CRUKD/12/016.