A trial looking at pembrolizumab with radiotherapy for non small cell lung cancer (KEYNOTE-867)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 3

This is a trial of pembrolizumab with stereotactic radiotherapy for early stage non small cell lung cancer. 

Early stage cancer is cancer that is small and hasn’t spread. 

It is for people who can’t have surgery to remove their non small cell lung cancer.

More about this trial

Surgery is the main treatment for early stage non small cell lung cancer (NSCLC). But if you aren’t fit enough to have surgery you might have stereotactic radiotherapy. 

Researchers are looking for ways to help improve the treatment for these people. They think that having pembrolizumab and stereotactic radiotherapy might help. 

Pembrolizumab is an immunotherapy. It works by stimulating the body’s immune system to fight cancer cells. 

In this trial half the people have:

  • stereotactic radiotherapy and pembrolizumab
  • stereotactic radiotherapy and a dummy drug (placebo Open a glossary item)

The main aims of the trial are to compare these 2 groups to find out:

  • which works best
  • how safe it is to have pembrolizumab and stereotactic radiotherapy
  • how each treatment affects quality of life Open a glossary item

Who can enter

The following bullet points list 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:

  • have non small cell lung cancer that measures less than 5cm across (stage 1 or stage 2A)
  • haven’t had treatment for your cancer
  • can’t have surgery to remove your cancer
  • can have stereotactic radiotherapy unless your cancer is very much in the centre of your chest
  • can look after yourself and are up and about for half the day (performance status 0, 1 or 2)
  • have satisfactory blood test results
  • are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant
  • are at least 18 years old 

Who can’t take part

You cannot join this trial if any of these apply. You:

  • have had treatment that works in a similar way to pembrolizumab
  • have had radiotherapy to the chest including the food pipe and breast
  • have had a live vaccination Open a glossary item within 30 days before starting treatment
  • have had an experimental drug or used an experimental device as part of another clinical trial within 4 weeks before starting treatment
  • are taking steroids at a dose of more than 10mg a day or any other medication that damps down the immune system Open a glossary item within 7days of starting treatment
  • have had another cancer within the past 3 years that has got worse or needed treatment apart from successfully treated non melanoma skin cancer Open a glossary item or any carcinoma in situ Open a glossary item for example breast and cervical
  • are known to be allergic to pembrolizumab or any of its ingredients
  • have inflammation of the lungs not caused by an infection (pneumonitis) or have had steroids to treat this in the past
  • have had hepatitis B
  • have an active infection of hepatitis C
  • have or had an autoimmune disease Open a glossary item in the past 2 years that needed treatment unless it was treatment to replace substances needed in the body for example hormone replacement for a thyroid gland that isn’t working well or insulin
  • have an infection that needs treatment that reaches the whole body (systemic treatment Open a glossary item)
  • have HIV
  • have had tuberculosis (TB)
  • have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part in the trial
  • are pregnant or breastfeeding
  • have had a stem cell or bone marrow transplant from another person (allogenic transplant Open a glossary item)
  • have had a solid organ transplant Open a glossary item such as kidneys or liver

Trial design

This is an international phase 3 trial. The trial team need 530 people worldwide with 40 in the UK to join. 

This is a randomised trial. There are 2 treatment groups. Neither you nor your doctor can choose which group you are in. And neither you nor your doctor will know which group you are in. This is a double blinded trial. 

The groups are:

  • stereotactic radiotherapy and pembrolizumab
  • stereotactic radiotherapy and a dummy drug (placebo)


You have a planning appointment before starting radiotherapy. This is to work out how much radiation you need and exactly where you need it. You have radiotherapy once a day Monday to Friday for 2 weeks. 

You have pembrolizumab or the dummy drug as a drip into a vein. You have it once every 3 weeks. Each 3 week period is a cycle of treatment Open a glossary item. You have 17 cycles of treatment that is about 1 year. 

Samples
You give extra blood samples and tissue samples (biopsies Open a glossary item) during the trial. Researchers use these to look for substances (biomarkers Open a glossary item) that can:

  • tell them how well treatment is working
  • what is happening in the body
  • tell them more about NSCLC

They’ll store these samples so other researchers can use them in the future.

You don’t have to agree to have these samples taken. You can still take part in the trial. 

Quality of life 
The researchers also want to find out what impact the treatment has on your quality of life. They will ask you fill in some questionnaires:

  • before you start treatment
  • during treatment
  • at the end of treatment
  • and during follow up

The questions ask about:

  • your general health
  • how active you are
  • any side effects 

These are quality of life questionnaires

Hospital visits

You see the doctor to have tests before taking part. These tests include:

You see the doctor:

  • every 3 weeks during treatment
  • at the end of treatment
  • then every 4 months to 3 years
  • then every 6 months 

You continue to see the doctor as part of the trial until you start another treatment, or your cancer starts to grow again. 

You have a CT scan and or an MRI scan at 3 months and then:

  • every 4 months to 3 years  
  • then every 6 months

Side effects

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. 

Pembrolizumab can affect the immune system. It may cause inflammation in different parts of the body which 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.

If you have any of these side effects, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy. 

The most common side effects of pembrolizumab include:

  • itching
  • rash
  • diarrhoea
  • cough
  • joint pain
  • loss of skin colour
  • back pain
  • tummy (abdominal) pain
  • high temperature (fever)
  • your thyroid gland not making enough hormone that might cause tiredness, weight gain, feeling cold, constipation
  • low level of salts in the blood that might cause tiredness, confusion, headaches, muscle cramps and or feeling sick 

We have more information about pembrolizumab and its side effects.

We have information about stereotactic radiotherapy and its side effects.

Location

Bristol
Darlington
Leicester
London
Northwood
Norwich
Oxford
Preston
Sheffield
Wirral

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 Ming Lee

Supported by

Merck, Sharp & Dohme

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16685

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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