A study looking at a new immunotherapy to treat non small cell lung cancer (MAGRIT)

Who can enter

You can enter this study if you

• Have non small cell lung cancer (NSCLC) that has not spread to another part of your body (stage 1b, 2 or 3a)
• Have NSCLC that makes a protein called ‘MAGE-A3’
• Have had surgery to remove your lung cancer (with or without chemotherapy after surgery)
• Have satisfactory blood tests
• Are well enough to take part (performance status 0, 1 or 2)
• Are willing to use reliable contraception during the study and for 2 months after if there is any chance that you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this study if you

• Have more than one cancer in the affected lobe of your lung, cancer cells in lymph nodes on the other side of your chest, or above your collarbone, or in the fluid around your lungs (stage 3b) or cancer that has spread to another part of your body
• Had surgery, but the surgeon could not remove all the lung cancer
• Had a type of lung cancer surgery called a wedge resection or a segmentectomy
• Have or have had another cancer, unless you have been clear for at least 5 years
• May be allergic to the study drug - you can check this with your doctor
• Have a disease where your immune system attacks your body tissues (an ‘autoimmune disease’) - except the skin condition ‘vitiligo’
• Are taking high dose steroids every day (not including inhalers or steroid cream) or other medication to suppress your immune system - please note, you must not stop taking steroids without speaking to your doctor
• Have had an organ transplant (for example, a kidney or heart transplant)
• Have a bleeding disorder that isn’t being controlled by treatment
• Have problems with the arteries that carry blood from your heart to the rest of your body, that are not controlled with treatment
• Have heart failure that is not controlled with treatment
• Have problems with heart rhythm that are not controlled with treatment
• Have high blood pressure that is not controlled by medication
• Have HIV
• Have oxygen therapy at home
• Will be taking other trial medication, or drug that is not licensed yet, within 30 days of the start of the study, or during the study
• Have any other condition that would make you unwell if you took part, or affect the results of the study - you can check this with your doctor
• Are pregnant or breastfeeding

Trial design

This is a phase 3randomised study. It will recruit 2,270 people around the world. 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. Or know which group you are in. This is called a ‘double blind’ study.

If you are in group 1, you have the MAGE-A3 ASCI. If you are in group 2, you have a dummy injection (‘a placebo’). 2 out of 3 people entering the trial will be in group 1, and so will have the immunotherapy.

Both groups will have a course of 13 injections, over 108 weeks. You have your injections into the muscle of your thigh or upper arm.

You will also give some blood samples. Researchers hope to identify proteins that may be linked to how well the vaccine works. The study team will also ask for permission to use these blood samples in future research.

If your cancer comes back you will stop the injections, but the research team will continue to monitor your progress. Your team will explain how they will do this.

Hospital visits

Before you start the study, you will see the doctor and have some tests. These tests include

• Blood test
• Chest X-ray
• CT scan of your chest and tummy area (your ‘abdomen’)
• CT scan or MRI scan of your brain (if appropriate)

Altogether, you have 13 injections of the vaccine or dummy drug. You start with an injection every 3 weeks for 5 doses. You then have an injection every 12 weeks for 8 doses. You will stay at the hospital for 30 minutes after each injection, so staff can monitor you for any immediate reactions to treatment.

This course of injections will last for 108 weeks. During this time you will also have

• Blood tests
• Pregnancy tests if appropriate (before each treatment, then every 3 months)
• A CT scan or chest X-ray (every 24 months)

When you have finished your injections you will see the doctor every 6 months. You may have the following tests

• CT scan or chest X-ray (every 12 months)
• CT scan or MRI scan of your brain (if appropriate)

At one visit you will also have a blood test. You will continue these checks until it is 5 years since your first injection.

After this, the study team will phone you once a year for another 5 years to monitor your progress.

Side effects

MAGE-A3 ASCI is still a new study drug, so there may be side effects we don’t know about yet. Side effects so far have included

• Redness, swelling and pain where you have your injection
• Flu like symptoms
• Tiredness
• Itching and a feeling of warmth

You may also have a rash, fever and chills (a ‘hypersensitivity reaction’) following your injection. Nurses will monitor you for this and treat any allergic reaction straight away.