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.

Cancer type:

Lung cancer
Non small cell lung cancer




Phase 1

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.

MK3475 is a type of biological therapy. It helps cells in the immune system to attack cancer cells.

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 steroids Open a glossary item or 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 autoimmune disease Open a glossary item
  • Have had certain lung diseases – the trial team can advise you about this
  • Have ever had leukaemia Open a glossary item or lymphoma Open a glossary item, 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 (ascites Open a glossary item or a pleural effusion Open a glossary item) 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

Trial design

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

Trial diagram

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.

Hospital visits

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 (ECG Open a glossary item)
  • A test to see how well your lungs are working

The trial team may ask you to have a new biopsy Open a glossary item. They will use this sample of your cancer to look for substances called biomarkers Open a glossary item. These may help to measure how well cancer responds to MK3475. You don’t have to have this biopsy if you don’t want to. You can still take part in the trial.

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.

Side effects

As MK3475 is a new drug, there may be side effects we don’t know about yet. In trials so far, the most common side effects have been

The trial team will talk to you about other possible side effects before you agree to join the trial.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Gary Middleton

Supported by

Sharp & Dohme

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 11477

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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