Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of a vaccine called Lucanix for advanced non small cell lung cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at Lucanix for people who have recently had chemotherapy for non small cell lung cancer that was stage 3 or 4.
Doctors can treat advanced non small cell lung cancer with chemotherapy. Some people also have radiotherapy. The cancer may get smaller, which doctors call a response. Or it may stay the same size, which doctors call
Researchers are looking for ways to improve treatment and stop the cancer starting to grow again. In this trial they are looking at a cancer vaccine called Lucanix. It may help the immune system to recognise and fight lung cancer cells.
The aims of the trial are to
- See if having Lucanix after chemotherapy can help people with non small lung cancer to live longer
- Learn more about the side effects
Who can enter
You may be able to enter this trial if you
- Have non small cell lung cancer that was staged as stage 3A (if it is T3, N2), stage 3B or stage 4
- Have had one type of chemotherapy for advanced non small cell lung cancer that included a
platinum drugand your cancer has stayed the same size ( stable disease) or got smaller
- Are about to finish chemotherapy or finished having it no longer than 3 months ago
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Are between 18 and 75 years old
You cannot enter this trial if you
- Have cancer that has spread to your brain, unless this has been treated and since treatment it has stayed the same size or got smaller
- Have cancer that has spread to your bones and is painful or needs treatment straight away
- Have a build up of fluid in your lungs (pleural effusion) that cannot be controlled
- Are allergic to eggs or soya
- Have lost more than 10% of your body weight within the last 6 weeks
steroids, or have done in the last 4 weeks, unless it is a low daily dose, for example an inhaler for breathing difficulties (it is important that you don’t stop taking steroids without talking to your doctor first)
- Have had surgery to remove your
- Have had a general
anaestheticin the last 4 weeks
- Have had radiotherapy,
immunotherapy, or an experimental drug in the last 4 weeks
- Have nerve damage from other treatment (peripheral neuropathy) unless it is mild
- Have had any other cancer apart from non melanoma skin cancer that has been in
remissionfor at least 2 years
- Have had an infection called Epstein Barr virus in the last 2 months
- Are known to be HIV positive
- Have any other condition that the trial doctors think could affect you taking part in this study
- Are pregnant or breastfeeding
This international phase 3 trial will recruit about 500 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
People in 1 group have injections of Lucanix every month for 18 months, then 2 more injections 3 months apart. So they have 20 injections all together over a 2 year period.
People in the other group have injections in the same way, but instead of the vaccine, they contain a dummy drug (
You have the injections just under the skin of your upper arm. The trial team will alternate the injection between your right and left arms.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination including tests to see how well your nervous system is working (neurological examination)
- Blood tests
- CT scan
- Heart trace (
- MRI scan of your brain
You may also have a bone scan if your cancer has spread to your bones.
You have 20 hospital visits during the 2 years of trial treatment. Each visit lasts 2 to 3 hours. As well as having blood tests, the researchers will ask about any side effects you have had and about your
You have a CT scan every 3 months. If you have cancer in your bones, you have a bone scan every 3 months.
If you have cancer that has spread to your brain, you have an MRI scan every 3 months.
The trial team would also ask you to have another MRI scan if there are signs that your cancer is getting worse.
You go back to see the trial team a month after your last injection. Then you see the team and have blood tests every 3 months for a year. You may have more scans during this time.
As Lucanix is quite a new drug, there may be some side effects we don’t know about yet. In earlier trials, the most common side effect was redness at the injection site. There may also be some swelling at the injection site and it can be itchy or sore for a few days.
There is a risk of a severe allergic reaction, causing difficulty breathing, flushing and low blood pressure. The trial team will monitor you closely and treat any problems. If you have a reaction, they will give you other medication before your next injection to try to stop it happening again.
Other likely side effects include
- High temperature (fever) and chills
- Tiredness (fatigue)
- Muscle and joint pains
- Feeling sick
Other possible side effects include
- An increased risk of bruising and bleeding
- High levels of sugar in your blood
- Low blood pressure
- Infection at the injection site, but this is rare
- Viral infections
It is also possible that Lucanix could cause a very strong response, destroying cancer cells and causing a swelling of the tumour. This might make any symptoms caused by your cancer worse for a while.
There are also some possible side effects associated with the dummy drug. The trial team will discuss these in more detail.
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.
Dr Ernie Marshall and Dr Rohit Lal
Experimental Cancer Medicine Centre (ECMC)