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.

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at a type of immunotherapy Open a glossary item to help delay or stop non small cell lung cancer coming back after surgery. If it’s diagnosed early enough, doctors may treat non small cell lung cancer (NSCLC) with surgery. You may also have chemotherapy after your surgery.But there is a risk that your cancer could come back and researchers are looking for new treatments to try to stop this happening.

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 antigen Open a glossary item that is found in your tumour (the PRAME antigen). To help your immune system, another substance called an adjuvant is added to the antigen. The adjuvant is a mixture of natural and manmade substances that help the immune system to respond.

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 (adjuvant therapy )
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 glands don’t work very well – the trial team can advise you about this
Need to take steroids or 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 spleen removed
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

Trial design

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 (placebos Open a glossary item ). There are twice as many people in the immunotherapy group as in the group having dummy injections.

10183 Trial Diagram

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.

Hospital visits

You see the trial team and have some tests before you start the injections. The tests include

Physical examination
Blood tests
Urine test
CT scan or MRI scan

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.