A trial of canakinumab for 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:
Status:
Phase:
This trial is for people with non small lung cancer that has been completely removed by surgery.
More about this trial


- 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
Who can enter
- 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 3 months after if you or your partner could become pregnant
- are at least 18 years old
- 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 or a
carcinoma in situ
- 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 (TB) or are at risk of getting TB
- have HIV
- are taking medications such as steroids that damp down your
immune system 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
- 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 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 ().
- 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



- 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 ) that could tell them how well canakinumab is working


Hospital visits
- a physical examination
- blood tests
- heart trace (
ECG )
- CT scan
- MRI scan
- bone scan if needed
- test for
tuberculosis (TB)
- a physical examination
- blood tests
- heart trace
- 6 months for 2 years
- year for another 2 years
- a physical examination
- blood tests
- CT scan and, or MRI scan
Side effects
- you have severe side effects
- your side effects aren’t getting any better
- your side effects are getting worse
- a drop in white blood cells causing an increased risk of infection
- infections
- an increase in red blood cells
- redness, itching, swelling and pain at the injection site
- changes to how the kidneys and liver work
- joint pain
- dizziness
- a problem with your balance that can make you feel dizzy (vertigo)
- tiredness
- feeling weak
- muscle and back pain
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.
Chief Investigator
Dr Kent Yip
Supported by
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040