Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of MK3475 for non small cell lung cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called MK3475 (also known as pembrolizumab) for non small cell lung cancer.
If non small cell lung cancer (NSCLC) has spread into the tissues surrounding the lungs or to another part of your body, doctors can treat it with chemotherapy. But researchers are looking for new ways of treating NSCLC. In this trial, they are looking at a new drug called MK3475.
The aims of this trial are to
- Learn more about the side effects of MK3475 and what happens to the drug in your body
- See if MK3475 helps people with non small cell lung cancer
Who can enter
You may be able to enter this trial if
- You have non small cell lung cancer that has spread into the tissues surrounding the lungs or to another part of your body
- Your cancer has certain gene changes – the trial team will test a sample of your cancer to check these
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- Your cancer can be measured on a scan
- You are at least 18 years old
- You are willing to use reliable contraception during the trial and for 4 months afterwards if there is any chance you or your partner could become pregnant
As well as the above, if you haven’t had any other lung cancer treatment, your cancer must produce a protein called PD-L1 – the trial team will test for this.
You cannot enter this trial if you
- Have cancer that has spread to your brain or spinal cord unless this has been successfully treated, has not got any worse for at least 4 weeks and you haven’t taken steroids for at least a week
- Have had a high dose of radiotherapy to your chest in the last 6 months (the trial team can advise you about this)
- Have had any other anti cancer treatment in the last 4 weeks (or in the last week if you had erlotinib, gefitinib, afatinib or crizotinib)
- Haven’t recovered from the side effects of earlier treatment
- Have had an experimental drug as part of another clinical trial in the last month
- Are expected to have any other anti cancer treatment during the time you will be in this trial
- Have already had MK3475 or another drug that works in a similar way – the trial team can advise you about this
- Need to take
steroidsor any other drugs that damp down your immune system, unless it is a low dose – the trial team can advise you about this
- Are at risk of bowel problems such as a blockage (bowel obstruction) or a split in the bowel wall (perforation) – your doctor can advise you about this
- Have an
- Have had certain lung diseases – the trial team can advise you about this
- Have ever had
leukaemiaor lymphoma, sarcoma or certain types of brain tumour, or you’ve had any other type of cancer unless it was successfully treated at least 5 years ago or more recently if it was very early stage
- Have had a bad reaction to a type of drug called a monoclonal antibody
- Have an infection that needs treatment
- Have a build up of fluid in your body (
ascitesor a pleural effusion) that is causing symptoms
- Have any other medical condition or mental illness that could affect your taking part
- Take drugs or drink large amounts of alcohol
- Are HIV, hepatitis B or hepatitis C positive
- Are pregnant or breastfeeding
This is a phase 1 trial. Everybody taking part has MK3475 through a drip into a vein. It takes half an hour each time.
There are 2 different groups of people in the trial.
- People in group 1have lung cancer that has spread to another part of their body (stage 4) and haven’t had any other treatment
- People in group 2 have had other treatment but their cancer has got worse since – some people will have had just 1 type of treatment, some will have had 2 or more other treatments - Please note recruitment to this group has now finished.
In each group, some people have MK3475 every 2 weeks and some have it every 3 weeks. How often you have treatment is chosen at random. Neither you nor your doctor can decide how you have treatment.
- In group 1, equal numbers of people have treatment 2 weekly and 3 weekly
- In group 2, for every 3 people who have treatment 3 weekly, 2 people have it 2 weekly
As long as you don’t have bad side effects, you can carry on having MK3475 for as long as it helps you.
If your cancer disappears completely after 6 months of treatment, you may stop having MK3475. If your cancer comes back later on, you are still taking part in the trial follow up phase, and you haven’t had any other cancer treatment, you may be able to start having it again.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests and urine tests
- CT scan or MRI scan
- Heart trace (
- A test to see how well your lungs are working
The trial team may ask you to have a new
Depending on how often you have treatment, you go to hospital every 2 or 3 weeks. Each visit lasts between 2 and 5 hours.
You have regular blood tests and urine tests. You have a CT or MRI scan at least every 9 weeks. And you may have an extra scan after 3 months of treatment.
When you finish treatment, you see the trial team about a month later. You then see them every 3 months until your cancer starts to get worse, or you start another treatment. From then on, a member of the trial team will contact you by phone every 3 months to see how you are.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Gary Middleton
Sharp & Dohme