"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of immunotherapy after surgery to remove non small cell lung cancer (PEARL)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a type of
In this trial, they are testing a treatment called PRAME immunotherapy. It works by teaching your immune system to recognise and destroy cancer cells.
You have injections of an
The aims of the trial are to
- See if PRAME immunotherapy is safe and how well it works in delaying or stopping non small cell lung cancer coming back after surgery
- 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 hasn’t spread beyond one side of your chest (stage 1A to stage 3A) and has been (or can be) completely removed with surgery
- Have cancer that produces the PRAME antigen – the trial team will test for this
- 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 at least 18 years old
- Are willing to use reliable contraception for a month before the trial, during treatment and for 2 months afterwards if there is any chance you could become pregnant
You cannot enter this trial if you
- Have had any other anti cancer treatment apart from surgery and chemotherapy to try to stop the cancer coming back (
- Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
- Have problems with your immune system, an
autoimmune disease, or your adrenal glandsdon’t work very well – the trial team can advise you about this
- Need to take
steroidsor other drugs that damp down your immune system (steroid inhalers and creams are allowed)
- Need to have continuous oxygen
- Have high blood pressure or certain heart problems – the trial team can advise you about this
- Have problems with bleeding that can’t be controlled with medication
- Have had your
- Have had allergic reactions in the past
- Have had any experimental treatment as part of another clinical trial in the last month
- Are known to be HIV positive
- Have any other medical condition or mental health problem that could affect you taking part
This phase 2 trial aims to recruit 220 people in a number of different countries. 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. This is called a double blind trial.
To begin with, the researchers need your permission to test your cancer to see if it produces the PRAME antigen. A piece of your cancer removed during surgery will be sent to the laboratory. It takes about a week to do this test. If your lung cancer does make the antigen, the trial team will give you more information about the trial and ask if you want to join.
If you agree to take part in the trial, you have up to 13 injections into a muscle in your thigh or your arm over the course of the treatment. Some people have PRAME immunotherapy, some have dummy injections (
You start having the trial injections after your surgery. If you have chemotherapy after surgery, you start the injections after your chemotherapy.
For the first 5 treatments, you have an injection once every 3 weeks. For the next 8 treatments, you have an injection once every 3 months.
You have regular blood tests throughout the trial. The researchers will look at your blood samples to see how your immune system is responding to the treatment.
The trial team will ask to take one extra blood sample to look at how differences in people’s DNA could be linked to the response to PRAME immunotherapy. But this test is optional. If you don’t want to give this sample for research you don’t have to. You can still take part in the trial.
If your cancer comes back during treatment, you will stop the injections and the trial doctor will talk to you about other treatment options. The trial team will then phone you once a year for up to 5 years to see how you are.
You see the trial team and have some tests before you start the injections. The tests include
You go to hospital to have the injections every 3 weeks for the first 12 weeks and then every 3 months for nearly 2 years. You have blood tests before each injection.
You have more CT scans during the trial to check if your cancer has come back. You have them every 3 months for 6 months, then every 6 months until a year after you have finished treatment, then once a year.
You see the trial team again 4 weeks after your last injection. You have follow up appointments after 2 months and then every 6 months for up to 5 years.
As PRAME immunotherapy is a new treatment, there may be side effects we don’t know about yet. The possible side effects include
- Pain, redness, swelling, itching or warmth at the injection site
- Flu like symptoms
- Loss of appetite
- Feeling or being sick
- Aching joints and muscles
Rarely, people have a severe reaction to immunotherapy. If this happens, it can be treated and you will not have any more injections.
How to join a clinical trial
Dr Paul Taylor
NIHR Clinical Research Network: Cancer