A trial looking at pembrolizumab and chemotherapy for non small cell lung cancer (KEYNOTE 189)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is for people who have advanced non small cell lung cancer. Advanced non small cell lung cancer (NSCLC) means one of the following
- the cancer is in both lungs
- the cancer has spread outside of the lung into the surrounding area, or elsewhere in the body
- there is a collection of fluid around the lung (pleural effusion) and this fluid contains cancer cells
More about this trial
, and are used to treat advanced NSCLC.
Pembrolizumab (also called MK3475) is a type of biological therapy called a monoclonal antibody. Monoclonal antibodies work by targeting a protein produced by the cell. Pembrolizumab targets a protein called PD-1. By blocking PD-1, the immune system is more able to fight the cancer.
Pembolizumab has already shown some promise in trials for people with lung cancer. People in this trial will have chemotherapy with or without pembrolizumab.
The aims of the trial are to
- find out if chemotherapy and pembrolizumab is better than chemotherapy alone
- learn more about the side effect of pembrolizumab and chemotherapy
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.
You may be able to join this trial if all of the following apply.
- You have non small cell lung cancer that is stage 4, or TNM stage M1a or M1b
- You have cancer that can be measured using scans, or by the doctor examining you
- You are willing to have a sample (
biopsies ) taken or have a sample of your cancer available for testing by the trial team. These should not be samples from areas that have been treated with radiotherapy - Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are willing to use reliable contraception during treatment and for at least 6 months afterwards if there is any chance that you or your partner could become pregnant
- You are at least 18 years of age or older
You cannot join this trial if any of these apply.
- Your NSCLC is mainly a type called squamous cell carcinoma or there are elements of small cell cancer lung cancer
- You have widespread cancer in your
abdomen , this is called abdominal carcinomatosis - You have cancer that has spread to your brain and this hasn’t been treated or is causing symptoms. You can take part if cancer spread to your brain has been treated, is not getting worse and if you do not need steroids in the 3 days before starting treatment in this trial
- You have inflammation of the covering of the brain (carcinomatous meningitis) caused by your cancer
- You are able to have EGFR or ALK directed treatment such as afatinib (Giotrif ) or crizotinib (Xalkori)
- You have already had pembrolizumab or a type of biological therapy such as erlotinib, crizotinib or cetumximab
- You have had treatment that reaches the whole body (
systemic therapy ) for advanced NSCLC. You may be able to take part if you have had systemic treatment before surgery (neo adjuvant therapy ) or after surgery (adjuvant therapy ) and this was at least 12 months ago - You have had major surgery in the last 3 weeks
- You have had radiotherapy treatment to your lungs that involved a dose higher than 30
Gray (Gy) in the last 6 months - You have had radiotherapy for symptom control in the last 7 days
- You have had treatment with a drug or device as part of a trial in the last 4 weeks
- You are allergic to the drugs (or similar drugs) used in this trial
- Your doctors think you may need another anti cancer treatment during the time you’re in the trial
- You have had another type of cancer in the last 5 years, unless it has been successfully treated
- You have an infection that needs treatment
- You have fluid on your lung (pleural effusion) or a collection of fluid in the abdomen (
ascites ) that is causing symptoms, you may be able take part if you have had treatment and you don’t have symptoms at the moment - You have diverticulitis that is causing symptoms and you need treatment for
- You have a blockage (obstruction) anywhere in your
digestive system or you have an collection of pus (abscess) in your abdomen - You have active hepatitis B or hepatitis C
- You have HIV
- You have interstitial lung disease or pneumonitis that needs glucocorticoid treatment either into a vein or as a tablet
- You are having treatment with steroids into a vein or as tablet, you can still take part if you have steroid inhalers (for example for asthma) or you have steroid injections into one area of your body (for example for conditions such as arthritis)
- You have an autoimmune disease such as rheumatoid arthritis, or myasthenia gravis and you have needed systemic treatment for this in the last 2 weeks
- You cannot stop treatment with aspirin or non steroidal anti-inflammatory drugs to take part in this trial, this may depend on the type and dose of your drug
- You have had a live vaccine in the last 30 days
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- You are pregnant or breastfeeding
Trial design
This is a phase 3 trial. The researchers need about 570 people to join.
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. And neither of you will know which group you are in. This is called a double blind trial.
- one group have chemotherapy and pembrolizumab
- the other group have chemotherapy and a dummy drug (placebo), this is the
control group )
You have pembrolizumab or saline through a drip into a vein. Saline is salt water, this is the placebo.
You have pembrolizumab or the saline once every 3 weeks. It takes about 30 minutes each time.
On the same day you have chemotherapy using the drugs
- pemetrexed
- carboplatin or cisplatin
Your doctor will explain whether carboplatin or cisplatin is best for you.
You have
- pemetrexed over about 10 minutes
- cisplatin over 30 minutes or carboplatin between 15 minutes and 1 hour.
Each 3 week period is called a cycle of treatment and you have 4 cycles.
After 4 cycles, you stop having either cisplatin or caboplatin. You continue treatment with pemetrexed and pembrolizumab or the saline infusion. You have this every 3 weeks.
You have this treatment as long for as it is helping you and you don’t have any severe side effects.
Crossover treatment
If your cancer continues to grow or starts to grow again, the trial doctor can find out which treatment group you are in. If you are in the group having the placebo, you may be able to take part in the crossover treatment. This means you have pembrolizumab on its own every 3 weeks.
If you have been having pembrolizumab, you finish treatment as part of this trial. You doctor can discuss other treatment options with you.
Second course treatment
If tests show that there are no signs of cancer, you may stop treatment. You may start a second course of pembrolizumab on its own if your cancer comes back. You doctor will discuss this with you in more detail.
Hospital visits
You see the doctors and have some tests before you start treatment. The tests include
You may be asked to have a ) of your cancer when you join this trial. If it is not possible for you to have a biopsy, the trial team will use a sample taken previously. The researchers use this to look for another protein called PD-L1. This may help them to understand why pembrolizumab might work in some cancers, but not others.
During treatment you go to hospital at least every 3 weeks to have blood tests, see a doctor and have your treatment.
You have extra blood samples taken at various points during your treatment. Where possible these are taken at the same time as your routine blood tests. But some of these will be extra blood tests. For example, you go to hospital for blood tests 3 times during your first cycle (first 3 weeks) of treatment.
The researchers use these samples for a number of tests. These include finding out what happens to pembrolizumab in the body () and looking for substances called .
You have further scans of your cancer every 1 to 2 months in the first year of treatment. Then every 3 months after that, while you have treatment.
When you finish treatment as part of this trial, you see the doctor 1 month after finishing, then every 6 weeks. They ask you how you are and about side effects. You have scans every 12 weeks.
If your cancer starts to grow again or if you start another treatment, your hospital visits as part of this trial finish. The trial team contact you by telephone every 3 months to find out how you are. You have no further scans as part of this trial.
Side effects
The most common side effects of pembrolizumab include
- itchy skin
- tiredness (fatigue)
- loss of appetite
- short of breath
- cough
- joint pain
- high termperature (fever)
- swelling of legs and, or feet
- back pain
- skin rash
- low levels of sodium in the blood (you have regular blood tests to monitor this)
- stomach pain
- feeling or being sick
- diarrhoea or constipation
- a drop in red blood cells causing tiredness and breathlessness
- patchy changes in your skin colour
The most common side effects of chemotherapy include
- tiredness
- feeling or being sick
- loss of appetite
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
We have information about
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.
Chief Investigator
Dr Clive Mulatero
Supported by
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
