"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at ceritinib for people with advanced non-small cell lung cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people with non small cell lung cancer that has spread to the brain or the membranes covering the brain and spinal cord (the leptomeninges). The tumour must also have a change to a protein called anaplastic lymphoma kinase (ALK).
More about this trial
Non-small cell lung cancer (NSCLC) can sometimes spread to other parts of the body, including the brain and the membranes surrounding your brain. This is called advanced non-small cell lung cancer.
There aren’t many options to treat advanced NSCLC that has spread to the brain and that have a change on the ALK protein. Doctors usually treat it with
Researchers are looking for other drugs to help people in this situation. In this trial they are looking at a drug called ceritinib.
When NSCLC has a change on the ALK protein it is called ALK positive. ALK proteins send signals to cancer cells telling them to grow. Ceritinib works by blocking the ALK protein. It stops the cancer dividing and growing.
The aims of this trial are to
- find out how well ceritinib works
- find out what happens to ceritinib in your body
- learn more about the side effects of ceritinib
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply
- You have non-small cell lung cancer that has spread into the brain or the surrounding tissues (leptomeningeal carcinomatosis)
- Your cancer has a change on the ALK protein (ALK positive)- the doctors will check for this
- You are willing to have a sample of your cancer taken (a biopsy) if there is no suitable sample available
- You have at least 1 area of cancer outside your brain that can be seen on a scan, measures at least 10 mm and hasn’t been treated with
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood tests
- You are at least 18 years old
- You are able to swallow tablets
- Any symptoms you have related to the cancer in your brain are stable in the week before you start the trial
- You are willing to use reliable contraception during treatment and for 3 months afterwards if there is any possibility you or your partner could become pregnant
You cannot join this trial if any of these apply.
- You have already had ceritinib
- You are known to be sensitive to ceritinib or anything it contains
- You have had chemotherapy, a biological therapy or a new experimental treatment in the last 2 weeks. If you have had chemotherapy using the drug mitomycin C or one from a group of drugs called
nitrosoureasyou must have finished your treatment at least 6 weeks ago
- You have had a drug that blocks the ALK protein in the last week (such as crizotinib)
- You have had surgery or stereotactic radiosurgery in the last 2 weeks.
- You need or are due to have any treatment to your brain such as surgery, radiotherapy or intrathecal chemotherapy after you have started the trial
- You have had radiotherapy to your lungs in the past 4 weeks or you had radiotherapy to any other part of your body in the past 2 weeks
- You have had a major surgery in the past 4 weeks. If you had a small operation where your doctor looked inside your chest through a camera you may still be able to take part
- You have moderate to severe side effects from any previous anti cancer treatments (apart from hair loss)
- You have had another cancer in the last 3 years apart from cancers that have not spread (known as
carcinoma in situ), basal cell cancers or squamous cell skin cancers that have been successfully treated
- You have heart problems such as congestive heart failure, a heart attack in the last 6 months, high blood pressure that is not controlled by medication or angina that is not controlled
- You have certain lung conditions such as interstitial lung disease or inflammation of the lung tissue (called
- You have problems with your
digestive systemsuch as ulcers, constantly feeling or being sick, diarrhoea or a malabsorption syndrome
- You have problems with your pancreas such as
pancreatitisand raised pancreas enzymescalled amylase and lipase
- You have problems with your
immune systemor you are not on a stable dose of corticosteroids (drugs that damp down your immune system)
- You are taking warfarin sodium or any other similar drug that stops your blood from
- You are taking drugs that affect some enzymes called CYP or can affect your heart function
- You have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- You are pregnant or breast feeding
This is an international phase 2 trial. The researchers hope that about 6 people in the UK will take part.
Everyone will take 5 tablets of ceritinib every day, at the same time. You will continue taking ceritinib for as long as it helps you and the side effects aren’t too bad.
You have some extra blood tests as part of this trial. The researchers want to find out what happens to ceritinib in the body.
They will also ask your permission to look for substances in your blood called
The researchers need to check to see if your cancer is ALK positive. They will use a tissue sample of your cancer (a
Researchers will also ask your permission to look for biomarkers in your tissue sample. You can tell the researchers if you don’t want them to use your sample for this research. You can still take part in the trial.
Cerebrospinal fluid samples
If you are one of the first 15 people taking part on this trial, the researchers will ask you to have a sample of the fluid around your brain taken at set times. This is called
If you have these samples taken, the researchers will ask your permission to look for biomarkers. Again you do not need to agree to this research if you don’t want to.
You see a doctor and have some tests before taking part. These tests include:
- A physical and neurological examination
- Blood tests
- Urine test
- CT scan and MRI scan of the brain
- Heart trace (
You see the doctor every week for the first month and then every 3 weeks. During each visit you have a physical examination, blood tests, urine test and a heart trace.
You have a CT scan and a MRI scan of the brain every 8 weeks. This continues as long as your cancer stays the same and does not get worse. If your cancer gets worse, you stop ceritinib.
When you stop treatment you see the trial team
- After 1 month
- Then every 3 months
Ceritinib is a new drug and there may be side effects we don’t know about yet.
The trial team monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
The most common side effects of ceritinib are
How to join a clinical trial
Dr Joyce Thompson