A trial comparing MK3475 with chemotherapy 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

Status:

Closed

Phase:

Phase 3

This trial is comparing a drug called MK3475 (also known as pembrolizumab) with chemotherapy for non small cell lung cancer. The trial is for people whose non small cell lung cancer has spread to another part of their body.

Doctors usually use a combination of the following chemotherapy drugs to treat non small cell lung cancer (NSCLC) that has spread

This is called standard treatment Open a glossary item. It works but they are always looking for better treatments.

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

In this trial the researchers want to compare MK3475 with the standard treatment for lung cancer that has spread.

The aims are to find out

  • How well MK3475 works for people with non small cell lung cancer
  • How safe MK3475 is
  • More about the side effects of MK3475
  • How MK3475 affects people’s quality of life Open a glossary item

Who can enter

You may be able to join this trial if all of the following apply

  • You have non small cell lung cancer (NSCLC) that has spread to another part of your body (stage 4)
  • Your cancer cells produce enough of a protein called PD-L1 (the trial team will test a sample of your cancer for this)
  • You have at least 1 area of cancer that can be seen on a CT scan
  • You have satisfactory blood test results
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply

  • Your cancer has certain gene changes (the trial team will test a sample of your cancer for these)
  • Your cancer has spread to your brain or spine, unless this has been successfully treated and is stable
  • You have had anti cancer drug treatment in the past 3 weeks, or radiotherapy Open a glossary item in the past 6 months
  • You have had a stem cell or bone marrow transplant from a donor Open a glossary item
  • You have had an organ transplant
  • You are expected to have any other anti cancer treatment during the time you will be in this trial
  • You have had an experimental drug as part of a clinical trial in the past month
  • You have already had MK3475 or other drugs that work in a similar way (your doctor can advise you about this)
  • You need to take steroids or any other drugs that damp down your immune system Open a glossary item, unless it is a low dose (the trial team can advise you about this)
  • You are going to have a live vaccine Open a glossary item within a month of starting treatment in the trial
  • You have an autoimmune disease Open a glossary item
  • You have certain lung diseases (the trial team can advise about this)
  • You have an infection that is being treated with antibiotics through a drip into your vein Open a glossary item
  • You have HIV, hepatitis B or hepatitis C
  • You have another medical condition or a mental health problem that the trial team thinks could affect you taking in the trial
  • You are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The researchers need 300 people to join.

Before you start treatment in the trial, the researchers need to make sure that your cancer produces enough of the PD-L1 protein. To do this they need a sample of your cancer tissue. They can take a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. If this isn’t available they will need to take a fresh sample of cancer tissue.

This trial is randomised. If you are able to take part, you will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in

  • People in group 1 will have MK3475
  • People in group 2 will have standard chemotherapy

Trial diagram

You have MK3475 through a drip into a vein every 3 weeks. It takes 30 minutes to give. You can continue having MK3475 for 2 years, as long as it is helping you and the side effects aren’t too bad.

If your cancer continues to get worse during treatment, you will stop having MK3475. If this happens your doctor will talk to you about having chemotherapy.

For people in group 2, your doctor will talk to you about which chemotherapy treatment may be the best for you. You will have one of the following

You have all the chemotherapy drugs through a drip into a vein every 3 weeks. Every 3 week period is called a cycle of treatment. You have between 4 and 6 cycles of treatment (so up to 18 weeks of treatment in total).

If your cancer gets worse during treatment, you doctor may talk to you about the possibility of having MK3475.

The trial team will ask you to fill out a questionnaire before you start treatment, every 3 weeks for 9 weeks, then every 9 weeks during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

The researchers will ask for some extra blood samples on 1 occasion when you have your routine blood tests done. You don’t have to agree to this, you can still take part in the trial.

Hospital visits

You see the doctor to have some tests before you take part in the trial. These tests include

  • A physical examination
  • Blood tests
  • Urine test
  • Heart trace (ECG Open a glossary item)
  • CT scan
  • MRI scan

During treatment you see the doctor every 3 weeks for blood tests and a physical examination. You have a CT scan every 9 weeks.

When you finish treatment you see the doctor about a month later, at 3 months, 6 months and then every 3 months for a physical examination until your cancer starts to get worse. If you had MK3475 you will also have a blood test. You have a CT scan every 9 weeks.

Side effects

MK3475 is a new drug and there may be side effects we don’t know about yet. The most common side effects include

We have information on the side effects of

Your doctor will talk to you about all the possible side effects before you agree to take part in 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 Christian Ottensmeier

Supported by

Experimental Cancer Medicine Centre (ECMC)
Merck Sharp & Dohme

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12270

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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