A trial looking at how food affects ceritinib in people with non small cell lung cancer

The following bullet points list the entry conditions for this study. Talk to your doctor or the study if you are unsure about any of these. They will be able to advise you.

You may be able to join this study if all of the following apply

• You have non small cell lung cancer that is stage 3b or stage 4 and has a change (mutation) in the ALK protein
• If your cancer has come back (relapsed) within a year of finishing your  initial treatment and you haven’t had any treatment for the relapsed cancer
• If you haven’t had treatment for your advanced NSCLC before
• You must have at least 1 area of cancer that can be measured on a scan
• 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 test results
• You are willing to reduce your alcohol intake to 1 drink a day for the 3 days before having blood samples taken as part of the study
• You are willing not to eat or drink the juice of grapefruit, pomegranate, starfruit and Seville orange for the 3 days before having blood samples taken as part of the study
• You are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
• You are at least 18 years old

You cannot join this study if any of these apply. You

• Have cancer spread to the brain or spinal cord unless there are no symptoms and you don’t need to have your dose of steroids increased within 2 weeks of starting treatment
• Have had any other treatment within 2 weeks of starting treatment in this study. For nitrosoureas  and mitomycin C you must have had them at least 6 weeks before starting treatment
• Still have side effects from any previous treatment apart from hair loss, skin and nail changes and mild peripheral neuropathy
• Have had another cancer in the past 3 years apart from non melanoma skin cancer  that has been completely removed by surgery and carcinoma in situ  of any kind that has been completely removed by surgery
• Have had radiotherapy to the lungs within 4 weeks of starting treatment. For radiotherapy to another part of the body and to relieve symptoms of bone pain it is 2 weeks
• Still have side effects from having radiotherapy
• Have had heart problems such as angina or heart attack, in the past 6 months
• Have congestive heart failure
• Have high blood pressure that isn’t controlled by medication
• Have had a disease affecting the lung, such as interstitial lung disease or pneumonia caused by radiotherapy, that affects your daily life
• Have a problem, such as ulcerative colitis, Crohn’s disease, being sick or diarrhoea, that could affect how your gut absorbs ceritinib
• Have had inflammation of the pancreas (pancreatitis) or an increase in the pancreatic enzymes amylase or lipase due to a disease of the pancreas 
• Are having certain medications that affect how the heart works or body substances called CYP enzymes unless they can be stopped at least 1 week before starting treatment
• Are taking warfarin or similar medication that affects how your blood clots
• Are taking steroids and the dose keeps changing or increasing. If you are taking steroids to replace hormones in the body or for symptom control you might be able to take part. The dose of these steroids must be stable or decreasing within 5 days of starting treatment
• Are taking medication to control fits (seizures), such as carbamazepine or phenytoin, unless it can be stopped a week before starting and during the study
• Are sensitive to ceritinib or its ingredients
• Have had major surgery within 4 weeks of starting treatment apart from video assisted thoracic surgery (VATS) and mediastinoscopy
• Have any other medical or mental health condition that the study team think could affect you taking part
• Are pregnant or breastfeeding