
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This is a trial of pembrolizumab with stereotactic radiotherapy for early stage non small cell lung cancer.
Early stage cancer is cancer that is small and hasn’t spread.
It is for people who can’t have surgery to remove their non small cell lung cancer.
Surgery is the main treatment for early stage non small cell lung cancer (NSCLC). But if you aren’t fit enough to have surgery you might have stereotactic radiotherapy.
Researchers are looking for ways to help improve the treatment for these people. They think that having pembrolizumab and stereotactic radiotherapy might help.
Pembrolizumab is an immunotherapy. It works by stimulating the body’s immune system to fight cancer cells.
In this trial half the people have:
The main aims of the trial are to compare these 2 groups to find out:
The following bullet points list 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
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The trial team need 530 people worldwide with 40 in the UK to join.
This is a randomised trial. There are 2 treatment groups. Neither you nor your doctor can choose which group you are in. And neither you nor your doctor will know which group you are in. This is a double blinded trial.
The groups are:
You have pembrolizumab or the dummy drug as a drip into a vein. You have it once every 3 weeks. Each 3 week period is a . You have 17 cycles of treatment that is about 1 year.
Samples
You give extra blood samples and tissue samples () during the trial. Researchers use these to look for substances (
) that can:
They’ll store these samples so other researchers can use them in the future.
You don’t have to agree to have these samples taken. You can still take part in the trial.
Quality of life
The researchers also want to find out what impact the treatment has on your quality of life. They will ask you fill in some questionnaires:
The questions ask about:
These are quality of life questionnaires.
You see the doctor to have tests before taking part. These tests include:
You see the doctor:
You continue to see the doctor as part of the trial until you start another treatment, or your cancer starts to grow again.
You have a CT scan and or an MRI scan at 3 months and then:
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.
Pembrolizumab can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They 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, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy.
The most common side effects of pembrolizumab include:
We have more information about pembrolizumab and its side effects.
We have information about stereotactic radiotherapy and its side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Ming Lee
Merck, Sharp & Dohme
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”