A trial of pembrolizumab with other treatment for non small cell lung cancer (KEYNOTE-799)

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

This trial is looking at adding pembrolizumab to chemotherapy and radiotherapy for non small cell lung cancer that can’t be removed by surgery.

It is open to people who haven’t yet had treatment for their lung cancer.

More about this trial

To treat non small cell lung cancer (NSCLC) that can’t be removed with surgery doctors use a combination of chemotherapy and radiotherapy (chemoradiotherapy). There are 2 main combinations of chemotherapy they use:

• carboplatin and paclitaxel
• cisplatin and pemetrexed

In this trial researchers want to find out if adding pembrolizumab to these treatments might work better.

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

The main aims of this trial are to find how:

well pembrolizumab works with these chemotherapy combinations and radiotherapy
safe it is to have pembrolizumab with these chemotherapy combinations and radiotherapy
having pembrolizumab with these chemotherapy combinations and radiotherapy affects your body

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 (NSCLC), haven’t had treatment for it and it can’t be removed by surgery
have stage 3 NSCLC
have an area of cancer that can be seen and measured on a scan
are fully active and are more or less as you were before your cancer (performance status 0 and 1)
have had a breathing test (lung function test) that shows your lungs are working well enough
have satisfactory blood test results
are willing to use reliable contraception during treatment and for up to 6 months after treatment 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.

Cancer related
You:

have had a scan that shows your cancer has spread to another part of the body
have small cell lung cancer (SCLC)
are to have radiotherapy to the whole lung and just under a third of the lung will get more than 20 Gray(Gy) of radiation in total
have had another cancer in the past 5 years that is getting worse or has needed active treatment apart from successfully treated non melanoma skin cancer, early (superficial) bladder cancer or a carcinoma in situ

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

have a recorded weight loss of more than 10% of your body weight within the past 3 months
have had radiotherapy to your chest (thorax) including radiotherapy to the food pipe (oesophagus)
have had radiotherapy for breast cancer
have already had treatment with a similar drug to pembrolizumab that works by affecting how your T cells work
have had an experimental drug or used an experimental device as part of another clinical trial in the past 4 weeks
have had an organ transplant
have had a donor stem cell or bone marrow transplant (allogeneic)
have a problem with your immune system
are taking more than 10mg of steroids a day or are taking another medication that affects how your immune system works within 7 days of starting treatment
are very sensitive to the drugs used in this trial or any of their ingredients
have an autoimmune disease that has needed treatment that reaches the whole body (systemic treatment) in the past 2 years apart from medication that replaces a substance in your body for example thyroid hormones for a thyroid that isn’t working well enough (hypothyroidism)
have or had lung problems that needed steroids
have an active infection that needs treatment that reaches the whole body
have HIV, hepatis B or hepatitis C
have had active tuberculosis (TB)
have any other medical condition or mental health problem that the trial team or your doctor think could affect you taking part in the trial

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

have had a live vaccine in the past 30 days of starting treatment
are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. The trial team need 220 people worldwide to take part with 21 people from the UK.

You are put into 1 of 2 groups according to what chemotherapy you have. Your doctor will talk to you about the chemotherapy that is most suitable for you.

People in group A have carboplatin, paclitaxel, radiotherapy and pembrolizumab.

People in group B have cisplatin, pemetrexed, radiotherapy and pembrolizumab.

You have treatment in 3 week periods. Each 3 weeks is called a cycle of treatment.

Group A (now closed)
You have carboplatin, paclitaxel and pembrolizumab as a drip into a vein. You have 3 cycles. You have radiotherapy for 6 weeks during cycle 2 and cycle 3.

You have radiotherapy once a day Monday to Friday.

After cycle 3 you continue to have pembrolizumab every 3 weeks. You continue to have pembrolizumab for up to a year as along as it is helping and the side effects aren’t too bad.

Group A is no closed to recruitment as there are enough people in this group.

Group B
You have cisplatin, pemetrexed and pembrolizumab as a drip into a vein. You have 3 cycles. You have radiotherapy for 6 weeks during cycles 2 and 3.

You have radiotherapy once a day Monday to Friday.

After cycle 3 you continue to have pembrolizumab every 3 weeks. You continue to have pembrolizumab for up to a year as along as it is helping and the side effects aren’t too bad.

Blood and tissue samples
Before starting treatment the research team take a small sample of tissue (biopsy) from the cancer. If they are unable to do this they will ask for a piece of the cancer tissue that was taken when you were first diagnosed.

During treatment you give blood samples.

The team will use these samples to find:

•   what happens to the drugs in your body
•   substances (biomarkers) that might tell them how well the treatment is working
•   out more about NSCLC

Hospital visits

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

physical examination
blood tests
heart scan (ECG)
breathing test to see how well your lungs work (lung function tests)
CT scan, MRI scan and if needed a PET scan

You see the doctor every 3 weeks during treatment to see how you are and for blood tests.

You have a scan every 9 weeks for a year and then:

every 3 months for another year and half then
every 6 months until your cancer starts to grow again

You see the doctor at the end of treatment to see how you are. You then see them every 3 months until your cancer starts to grow again or you start another treatment.

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 are:

loss of skin colour
itchy skin, rash
diarrhoea
cough
joint, back or tummy pain
high temperature (fever)
your thyroid could make too much hormone (hyperthyroidism) or too little (hypothyroidism)
low level of salt in the blood which can cause tiredness, confusion, headaches, muscle cramps and feeling sick

We have more information about pembrolizumab and its side effects.

We have information about the side effects of: