
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at adding nivolumab to chemoradiotherapy and comparing it to chemoradiotherapy alone.
It is also comparing 3 different immunotherapy treatments to have after these first treatments. These are nivolumab plus ipilumumab, nivolumab on its own and durvalumab.
It is for people with locally advanced lung cancer.
There are different treatment options for stage 3 non small cell lung cancer. Stage 3 lung cancer can also be called locally advanced cancer.
One common treatment is and
together, this is called
.
You might also have immunotherapy.
Immunotherapy uses our immune system to fight cancer. It works by helping the immune system recognise and attack cancer cells. But researchers don’t know if giving a type of immunotherapy at the same time as chemoradiotherapy is better than chemoradiotherapy on its own.
They also want to see if follow up treatment with two immunotherapy drugs that work slightly differently, helps people more than just one. Doctors call this follow up treatment maintenance. It is to try and keep the cancer under control.
Nivolumab blocks a protein called PD-L1 on the surface of immune cells. Blocking this protein triggers the immune system to find and kill cancer cells.
Ipilimumab works by attaching itself to normal immune cells. This changes the way these cells work and helps the immune system destroy cancer cells.
Durvalumab seeks out cancer cells by looking for the PD-L1 protein and attaching to it. The immune system then recognises the marked cells and kills them.
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.
There are some additional entry conditions for the second part of the trial.
Who can take part (chemoradiotherapy stage)
You may be able to join the chemoradiotherapy part of trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join the chemoradiotherapy part of the 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:
Maintenance treatment
There are some additional entry conditions for the second part of the trial. This is the maintenance part of the trial.
Who can take part (maintenance stage)
You may be able to join the maintenance part of trial if all of the following apply:
You might not be able to take part in the maintenance part of the trial if any of these apply. You:
This is a phase 3 trial. The researchers hope 888 people will take part worldwide including 30 from the UK.
The trial is split into 4 stages:
It is a randomised trial. You are put into 1 of the following treatment groups by computer:
You have chemotherapy and immunotherapy as a drip into a vein. You have radiotherapy from a machine outside the body.
Chemoradiotherapy stage
Everyone has chemotherapy with or without immunotherapy in cycles. Each 3 week period is a cycle of treatment. The trial team will let you know how often you have treatment, which chemotherapy drugs you have, and how long each cancer drug takes.
Everyone has radiotherapy, this is usually Monday to Friday for 6 to 7 weeks. You start radiotherapy with your second cycle of chemotherapy.
Maintenance stage
Everyone has immunotherapy:
The maintenance stage is up to a year. You have treatment for as long as it is working, and the side effects aren’t too bad.
Quality of life
The trial team will ask you to fill out questionnaires:
The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Samples for research
The trial team will ask you to give some extra blood samples. Where possible you have these at the same time as your routine samples.
They will ask to look at a sample of tissue you gave when you were first diagnosed.
The researchers plan to look at:
They might also ask you to give a new sample if your cancer gets worse.
Treatment during follow up
You might be able to have more treatment if your cancer gets bigger during the follow up period. To have this you need to have completed a year of treatment with nivolumab, with or without ipilimumab.
This will be the same treatment you had as maintenance treatment.
You’ll see a doctor and have some tests before you can take part. These include:
Hospital visits during treatment
You have treatment at the hospital. How often you go depends on which treatment group you are in.
At each visit, you see the trial doctor for a check up and blood tests. You have extra blood tests to check the levels of nivolumab and ipilimumab, if you are in these study groups.
CT or MRI Scans
You have a scan:
The trial team think you will have 10 more scans during the trial, than you would if receiving standard of care treatment. It’s likely that you will have to visit the hospital as an extra visit for these.
After the maintenance treatment phase, you see the trial doctor for a check up and blood tests:
After that, the trial team will catch up with you every 3 months. This will be either at the hospital or over the phone.
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.
Nivolumab, ipilimumab and durvalumab can affect the immune system. They may cause inflammation in different parts of the body. This 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. In particular, the team caring for you will look out for signs of breathlessness or other signs of lung inflammation. 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 nivolumab include:
The most common side effects of having nivolumab and ipilimumab together are:
The most common side effects of durvalumab are:
We have information about:
The side effects of radiotherapy to the chest include:
We have more information on possible side effects of lung chemoradiotherapy. Your doctor will talk to you about all the possible side effects before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Anoop Haridass
Bristol-Myers Squibb
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.