A trial looking at ceritinib for people with advanced non-small cell lung cancer

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 radiotherapy
• 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 nitrosoureas you 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 pneumonitis )   
• You have problems with your digestive system such as ulcers, constantly feeling or being sick, diarrhoea or a malabsorption syndrome
• You have problems with your pancreas such as pancreatitis and raised pancreas enzymes called amylase and lipase
• You have problems with your immune system or 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 clotting
• 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