
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at pembrolizumab and epacadostat as the first treatment for non small cell lung cancer that has spread elsewhere in the body.
The usual treatment for advanced non small cell lung cancer is chemotherapy, radiotherapy or a targeted cancer drug. You might have a type of targeted drug called pembrolizumab. It is a type of immunotherapy. It stimulates the body’s to recognise and attack cancer cells.
But sometimes it stops working and the cancer starts to grow again. So researchers are always looking for ways to improve treatment. In this study, they are looking at a new drug called epacadostat.
Epacadostat also works on the immune system but in a different way to pembrolizumab. It blocks a protein which can help the immune system to work better.
Researchers think that adding epacadostat to pembrolizumab will improve treatment. But they aren’t sure, so want to find out more.
In this study, some people have pembrolizumab and epacadostat. And some pembrolizumab alone.
The aims of the study are to:
The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all the following apply.
You:
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You
Medical conditions
You:
Other
You:
This is a phase 3 trial. The researchers hope to find 588 people to join the study including 6 from the UK.
It is a randomised study. A computer will put you into a treatment group. 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. We call this a double blind study.
You have 1 of the following treatments:
You have pembrolizumab as a drip into a vein. You have it once every 3 weeks.
Epacadostat and the dummy drug are tablets. You have either epacadostat or the dummy drug twice a day, everyday.
You have treatment for up to 2 years, for as long as it is working and the side effects aren’t too bad.
After 2 years of treatment you might be able to continue if the treatment is working. The trial doctor can tell you more about this.
You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Quality of life
The study team will ask you to complete some questionnaires before treatment starts and then regularly throughout treatment. We call these questionnaires. They look at how the treatment affects you physically and emotionally.
Research samples
The researchers will ask you to have some extra blood tests. They will also ask to use a tissue sample (biopsy) of your cancer that you had taken when you were diagnosed. You need to have a biopsy if there isn’t a suitable sample available.
They plan to use the samples to:
They might ask to use any leftover samples for future research. You don’t have to agree to this if you don’t want to. You can still take part in the study.
You see a doctor and have some tests before taking part. These tests might include:
You might need to give a tissue sample ( if there isn’t a sample available for the study team to do some tests on.
You have a CT or MRI scan every:
The study team will follow you up every 3 months if your cancer gets worse. They will phone you to see how you are getting on.
Having epacadostat and pembrolizumab together is a new combination of treatment. And epacadostat is a new drug, so there might be some side effects we don’t know about yet.
The study team will monitor you during the time you have treatment and you’ll have a phone number to call them if you are worried about anything.
The most common side effects of epacadostat include:
The most common side effects of pembrolizumab include:
The study team will talk to you about all the possible side effects of having treatment. We have more information about pembrolizumab.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Katy Clarke
Merck, Sharp & Dohme
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”