
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This trial is looking at 2 vaccines with standard treatment for non small cell lung cancer that has spread from where it started.
Cancer Research UK supports this trial.
One of the for non small cell lung cancer (NSCLC) is chemotherapy and
. The chemotherapy can be either:
The immunotherapy can be pembrolizumab.
In this trial researchers are looking at the ChAdOx1-MAGEA3-NYESO vaccine and the MAGE-A3 vaccine.
MAGE-A3 and NYESO-1 are proteins found on some cancer cells. Not everyone has them and not every cancer type has these proteins.
The vaccines contain harmless parts of the MAGE-A3 and NYESO-1 proteins. The vaccines work by helping the find the proteins. The immune system recognizes them as something foreign in the body and attacks them.
have shown that the vaccines help the immune system recognize and attack cancer cells with these proteins.
Researchers want to find out if this happens when people with cancer have the vaccines.
There are 2 parts to this trial. In the first part a small number of people have the vaccines with the standard treatment. The team want to find out how safe it is to give them with standard treatment.
In the second part you either have:
The aims of this trial are to find out:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is a phase 1/2 trial. There are 2 parts to this trial.
In the first part the team need up to 6 people to join. All have the vaccines with the standard treatment. They are monitored for any side effects. This is to make sure it is safe to give the vaccines with chemotherapy and pembrolizumab.
For the second part the team need 80 people to join. This part is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:
Your doctor will talk to about which is best treatment for you.
Pembrolizumab, pemetrexed and cisplatin or carboplatin
You have pembrolizumab, pemetrexed and cisplatin or carboplatin as a drip into a vein. You have them every 3 weeks. This is a .
After 4 cycles of treatment you then have either:
Pembrolizumab, paclitaxel and carboplatin
You have pembrolizumab, paclitaxel and carboplatin as a drip into a vein. You have them on the same day every 3 weeks. This is a cycle of treatment. You have 4 cycles of treatment.
You then have pembrolizumab:
Vaccines
You have the vaccines as an injection into a muscle. You have them in the muscle at the top of the arm, top of the leg or the buttocks. You have them in the same muscle all the time unless it becomes sore or there is a reaction.
You have the first vaccine just before you have your 3rd cycle of treatment (9 weeks). You then have the second vaccine before you have the 4th cycle of treatment (12 weeks).
If you continue with the standard treatment you might have the first vaccine again before the 8th cycle of treatment. And the second vaccine before the 9th cycle of treatment.
Patient diary cards
You have a diary cards to complete every day. The team explains how to use them. You record details about:
You must bring the cards with you when you attend your hospital appointments.
Samples for research
The team take extra blood samples during the trial. Where possible they take these when you have your routine bloods done.
Researchers use these samples to find out:
You see the doctor to have tests before taking part. These tests include:
• a
• blood tests
• CT scan or an MRI scan
• urine test
• heart trace ()
Everyone sees the doctor at regular times during treatment. This is for blood tests and to see how you are. You also have another CT scan or MRI scan.
Before your 10th cycle of treatment (between 30 and 60 weeks) you see the doctor. This is for blood tests and to see how you are. This is your last visit for the trial.
If you have side effects caused by the vaccines you see the doctor every month until the side effects are gone. Where possible these will be at the same time you have your routine appointments.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
This is the first time the ChAdOx1-MAGEA3-NYESO vaccine and MVA-MAGE3 vaccine are being used in humans. There might be side effects we don’t know about yet. Based on similar vaccines and laboratory studies the possible side effects might include:
Pembrolizumab and the vaccines can affect the immune system. They may cause inflammation in different parts of the body. This can cause serious side effects. These side effects could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
We have information about:
• pembrolizumab
• paclitaxel and carboplatin
• pemetrexed and cisplatin
• pemetrexed and carboplatin
Your doctor or a member of the trial team will talk to you about the possible side effects of the treatments before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Fiona Blackhall
Cancer Research UK
This is Cancer Research UK trial number CRUKD/20/001.
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”