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.

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Closed

Phase:

Phase 2

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 chemotherapy Open a glossary item. They can also use biological therapies and often give a drug called crizotinib.

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

Trial design

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. 

Blood tests 
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 biomarkers Open a glossary item. The researchers are looking to see why treatments work better for some people than others. You do not have to agree to have this blood test for research if you don’t want to. You can still take part in the trial. 

Tissue samples
The researchers need to check to see if your cancer is ALK positive. They will use a tissue sample of your cancer (a biopsy) Open a glossary item taken either when you were diagnosed or during other treatment if it is available. If there is not a suitable sample available the researchers will ask you to have another biopsy.

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 cerebrospinal fluid Open a glossary item.

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.

Hospital visits

You see a doctor and have some tests before taking part. These tests include:

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

Side effects

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

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Joyce Thompson

Supported by

Novartis 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13654

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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