
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.
This trial is looking at adding oleclumab or monalizumab to durvalumab for non small cell lung cancer.
It is for people whose cancer:
Chemoradiotherapy is a combination of chemotherapy and radiotherapy. It is a standard treatment for non small cell lung cancer (NSCLC). After chemoradiotherapy you might have durvalumab.
Durvalumab is an immunotherapy. It works by stimulating the to fight cancer. This can slow down or stop the growth of the cancer. It is a
for some people after chemoradiotherapy for NSCLC.
Oleclumab and monalizumab are also immunotherapies. They work in slightly different ways. They also help the immune system to recognise and attack cancer cells.
Doctors are looking at ways to improve treatment for non small cell lung cancer after chemoradiotherapy. In this trial you have one of the following:
The main aims of the trial are to:
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 phase 3 trial is taking place worldwide. The team need 999 people to have treatment in the trial with 44 people from the UK.
It is a randomised trial. There are 3 treatment groups with about 333 people in each group. Neither you nor your doctor can choose which group you are in. Nor will you know which group you are in. Your doctor can find this out if necessary.
You have one of the following:
You have all your treatment as a drip into a vein. It takes about an hour to have each drug.
You have treatment in cycles. Each 4 week period is a . The first day of each treatment cycle is called day 1. For the first 2 months only, you have:
After that you have all your treatment on day 1 of each treatment cycle. You have this once every 4 weeks for up to one year. This is for as long as it is working and the side effects aren’t too bad.
You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Samples for research
The trial team ask you to give some extra blood samples. Where possible you have these at the same time as your routine blood tests.
They might ask you to give an extra sample of tissue if your cancer gets worse.
The researchers plan to use the samples to:
You can say no to giving the extra tissue sample if your cancer gets worse. It won’t affect you taking part in the rest of the trial.
Quality of life
The trial team ask you to fill out a questionnaire:
You do this on a phone or an electronic device. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have tests before you can take part. These include:
You see the doctor before each treatment to see how you are and for blood tests.
At home the team ask you to check your levels of oxygen in the blood. They provide you with a small device to do this. They’ll let you know when and how often to do this.
Scans
You have a scan every:
You stop having these trial scans if your cancer gets worse. If this happens, you will also have one more scan a few months later. Your doctor can tell you more about this.
Follow up
After you finish treatment you see the doctor for a check up one month later. And then you see them:
The team then contact you every 2 months to see how you are getting on. They check if you have started another cancer treatment.
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.
Durvalumab, oleclumab and monalizumab 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. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The combination of durvalumab and monalizumab is a new treatment. The combination of durvalumab and oleclumab is also a new treatment. So there may be possible side effects we don’t know about yet.
Not many people have had oleclumab. The most common side effects of durvalumab and oleclumab we know about so far include:
The most common side effects of oleclumab alone include:
Other possible side effects of oleclumab include:
The possible side effects of monalizumab we know about so far include:
Symptoms of an allergic reaction include flushing, skin rash, fever, chills or shortness of breath. Severe reactions can cause breathing problems, low blood pressure and heart problems. This needs urgent treatment.
The team keep a close eye on you during treatment and afterwards. They will treat any problems straight away.
We have more information about durvalumab and its side effects.
Your doctor will talk to you about all the possible side effects of treatment before you join the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Grant Stewart
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
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.