A trial comparing MK3475 with docetaxel 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 2/3

This trial is comparing a new drug called MK3475 (also known as pembrolizumab) with docetaxel (Taxotere) for non small cell lung cancer (NSCLC). The trial is for people who have already had treatment for their lung cancer with a chemotherapy drug from the platinum drugs group Open a glossary item.

Doctors can initially treat NSCLC with chemotherapy including a platinum drug such as carboplatin or cisplatin. If this doesn’t work then they can use another chemotherapy drug called docetaxel. This is the standard treatment Open a glossary item but researchers are always looking for ways to improve treatment.

MK3475 is type of biological therapy. It works by helping the immune system recognise cancer cells. In this trial, the researchers want to compare 2 different doses of MK3475 with docetaxel.

The aims of this trial are to find out

  • How well MK3475 works for people with non small cell lung cancer
  • How safe MK3475 is
  • How MK3475 affects quality of life Open a glossary item

Who can enter

You may be able to enter this trial if

  • You have non small cell lung cancer that is locally advanced (stage 3B), spread to another part of your body (stage 4) or has come back after treatment
  • You have at least 1 area of cancer that can be seen on a scan Open a glossary item
  • You have scans that shows your cancer has continued to grow after having chemotherapy including a platinum drug
  • Your cancer has the EGFR gene change - you must also have had a scan that shows your cancer continued to grow after having erlotinib or gefitinib
  • Your cancer has the ALT gene change - you must also have had a scan that shows your cancer continued to grow after having crizotinib
  • Your cancer produces a protein called PD-L1 – the trial team will test for this
  • 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
  • You are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any chance that you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter this trial if

  • You have already had docetaxel to treat your lung cancer
  • Your cancer has spread to your brain or spinal cord – you may be able to take part if your cancer spread has been treated, you have had a MRI scan Open a glossary item that shows it is stable, you have no symptoms and haven’t had steroids in the 3 days before starting treatment as part of this trial
  • You still have moderate to severe side effects from your previous chemotherapy, apart from hair loss
  • You have had treatment in the past 3 weeks apart from erlotinib, gefitinib or crizotinib
  • You have had above a certain dose of radiotherapy in the past 6 months apart from radiotherapy for pain – your doctor can advise
  • You have taken part in a clinical trial in the past month
  • You are taking medication that damps down your immune system Open a glossary item
  • You have had steroids within 3 days of starting treatment in this clinical trial
  • Your doctor recommends you have further treatment
  • You had a drug that works in the same way as MK3475 – your doctor can tell you this
  • You have had a live vaccine Open a glossary item in the past month
  • You had another cancer in the past 5 years apart from some successfully treated early cancers Open a glossary item
  • You have, or have had, an autoimmune disease Open a glossary item
  • You have any other lung disease, apart from asthma
  • You have had an organ transplant
  • You have had a tissue Open a glossary item transplant, such as a heart valve replacement or a bone marrow transplant from a donor
  • You have an infection that is been treated with antibiotics through a drip (intravenous infusion Open a glossary item)
  • You are known to be HIV, hepatitis B or hepatitis C positive
  • Your use of drugs or alcohol is a cause of concern
  • You have another medical condition that could affect you taking part in this trial
  • You are pregnant or breastfeeding

Trial design

This is a phase 2/3 trial. It will recruit 920 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • People in group 1 have MK3475
  • People in group 2 have a higher dose of MK3475
  • People in group 3 have docetaxel

trial diagram

You have MK3475 or docetaxel as a drip into a vein every 3 weeks. You continue to have treatment for up to 2 years as long as it is helping you and the side effects aren’t too bad.

The researchers will ask for a sample of your cancer that was removed when you had a biopsy Open a glossary item and for some extra blood samples. They will ask your permission to store these for future research. You don’t have to agree to have them stored if you don’t want to.

The trial team will ask you to fill out 3 questionnaires before you have your 1st, 2nd, 3rd and 5th treatments, then every 12 weeks during treatment and after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

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

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

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

You see the doctor 1 month and 3 months after you finish treatment and then every 3 months until your cancer gets worse or you start another cancer treatment.

You have a CT scan or MRI scan every 9 weeks.

If your cancer gets worse or you start another cancer treatment, the trial team will then phone you every 2 months to see how you are.

Side effects

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

We have more information about the side effects of docetaxel.

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 Dean Fennell

Supported by

Experimental Cancer Medicine Centre (ECMC)
Merck
Sharp & Dohme
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10623

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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