A trial of canakinumab for non small cell lung cancer

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 2

This trial is for people with non small lung cancer that has been completely removed by surgery.

More about this trial

Canakinumab works by stopping inflammation Open a glossary item.
 
We know that ongoing (chronic) inflammation plays an important role in the development of non small cell lung cancer. Researchers think that stopping inflammation could help stop non small cell lung cancer developing.
 
In this trial researchers will compare canakinumab with a dummy drug (placebo Open a glossary item).
 
The aims of this trial are to find out:
  • how well canakinumab works for non small cell lung cancer
  • more about the side effects
  • what happens to canakinumab in the body
  • what effect it has on the quality of life Open a glossary item

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. 
 
Who can take part
You may be able to join this trial if all of the following apply. You:
  • have non small cell lung cancer (NSCLC) that is stage 2A or 2B, or stage 3A or 3B
  • have had surgery to remove the cancer completely
  • have had chemotherapy containing cisplatin unless your cancer was stage 2A and was less than 4cm across
  • are able to do anything apart from heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results
  • are willing to use reliable contraception during treatment and for up to 5 months after if you or your partner could become pregnant
  • are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. 
 
Cancer related
You:
  • have cancer that can’t be removed by surgery or wasn’t completely removed by surgery 
  • have cancer that has spread to another part of the body 
  • had chemotherapy or radiotherapy before surgery 
  • have had radiotherapy to your lung 4 weeks or less before starting treatment in this trial 
  • still have side effects from any treatment apart from hair loss and mild nerve damage
  • have had or have been treated for another cancer in the past 3 years apart from successfully treated non melanoma skin cancer Open a glossary item or a carcinoma in situ Open a glossary item
Medical conditions
You cannot join this trial if any of these apply. You:
  • have a disease of the lung tissue that can cause breathing difficulties
  • have had a heart attack, heart surgery or unstable angina in the past 6 months 
  • have another serious heart condition such as congestive heart failure
  • have had major surgery within 4 weeks before being put into a treatment group for this trial 
  • have diabetes that isn’t controlled
  • have an active or ongoing liver problem such as hepatitis B, hepatitis C or cirrhosis
  • have or have had tuberculosis Open a glossary item (TB) or are at risk of getting TB
  • have HIV
  • are taking medications such as steroids that damp down your immune system Open a glossary item apart from creams and inhalers
  • had an experimental drug or used an experimental device as part of another clinical trial in the past month
  • are to take part in another clinical trial using an experimental drug or device
  • are taking other drugs that target the immune system for example TNF blockers, rituximab or anakinra 
  • have any other medical or mental health condition that your doctor or the trial team think could affect you taking part
Other
You cannot join this trial if any of these apply. You:
  • have had canakinumab before or another drug that works in a similar way
  • are sensitive or allergic to canakinumab or any of its ingredients
  • had a live vaccine Open a glossary item within 3 months of starting treatment
  • are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The team need about 1,500 people to take part worldwide.

It is a randomised trial. Everyone taking part is put into 1 of 2 groups. Neither you or your doctor can choose which group you are in. Neither you or your doctor will know which group you are in. This is called a double blind trial.

Half the people will have canakinumab. The other half will have a dummy drug (placebo Open a glossary item).

You have canakinumab and the dummy drug as an injection under the skin (subcutaneous injection). You have 2 injections at each treatment. You have the injections in your upper arm, upper leg or the tummy (abdomen). 
 
You have the injections every 3 weeks. Each 3 week period is called a cycle of treatment. You have 18 cycles of treatment. 
 
Quality of life
You fill in a questionnaire:
  • when you agree to take part
  • before each treatment
  • when you have finished treatment
  • then every 4 weeks for about 4½ months
  • every 6 months for 2 years
  • then once a year for 2 years
The questions are about your general health and wellbeing, and any side effects you might have. This is a quality of life questionnaire
 
Tissue samples
The team will take a small piece of tissue from your lung if they think your cancer has come back and this can’t be confirmed using a scan such as a CT scan Open a glossary item
 
They will ask for a small piece of cancer tissue if your cancer comes back or you start a new treatment for your cancer. If your doctor has already taken a piece of tissue because your cancer has come back, then the researchers can use this. 
 
You don’t have to agree to this. You can still take part in the trial.
 
The team will use these tissue samples to look for changes (mutations Open a glossary item) in the genes Open a glossary item that could tell them why your cancer has come back.
 
Blood samples
The team will take several blood samples during treatment. They will use these samples to:
  • find out what happens to canakinumab in the body 
  • find out how canakinumab works in the body and what effect it has on the body
  • find out how the immune system responds to canakinumab
  • look for substances in the blood (biomarkers Open a glossary item) that could tell them how well canakinumab is working
When taking canakinumab, the team will also ask for a blood sample if you have a side effect that affects the immune system Open a glossary item, such as an infection or inflammation Open a glossary item. They will use this sample to find out why it happened. You don’t have to agree to have this sample taken. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before you take part. These include:
  • a physical examination
  • blood tests
  • heart trace (ECG Open a glossary item)
  • CT scan
  • MRI scan
  • bone scan if needed
  • test for tuberculosis Open a glossary item (TB)
During treatment you see the doctor at the beginning of each treatment for a physical examination and blood tests. 
 
You have a heart trace at cycle 6 of treatment (24 weeks).
 
You have a CT scan and, or MRI scan every 12 weeks. 
 
You see the doctor at the end of treatment for:
  • a physical examination
  • blood tests
  • heart trace
You then see the doctor every month for about 5 months for blood tests and to see how you are. 
 
Then you see the doctor every:
  • 6 months for 2 years 
  • year for another 2 years
At each visit you have:
  • a physical examination
  • blood tests 
  • CT scan and, or MRI scan
Every 3 months until the end of the trial a member of the team will phone you to see how you are.

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
  • you have severe side effects 
  • your side effects aren’t getting any better
  • your side effects are getting worse
The most common side effects of canakinumab are:
Your doctor or a member of the trial team will tell you about the possible side effects of canakinumab before you agree to take part.

Location

Birmingham
Bodelwyddan
Bristol
Cheltenham
Guildford
Ipswich
Liverpool
London
Norwich
Nottingham
Oxford
Preston
Scunthorpe
Stoke-on-Trent
Truro

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 Kent Yip

Supported by

Novartis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15820

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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