
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people with advanced non small cell lung cancer (NSCLC). Advanced NSCLC can mean one of the following:
It is for people who have a NSCLC that has a change (mutation) in receptors called epidermal growth factor receptors (EGFR). And that have had treatment with drugs called (TKI).
For advanced non small cell lung cancer, you usually have a combination of chemotherapy drugs. Chemotherapy uses anti cancer (cytotoxic) drugs to destroy cancer cells. Possible chemotherapy combinations are:
Pembrolizumab (also called Keytruda) is a type of immunotherapy called a monoclonal antibody. It helps the to attack the cancer and stop it from growing. Pembrolizumab is already a possible treatment for people with advanced NSCLC.
Everyone taking part in this trial has one of the following:
The main aims of this trial are to:
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:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
Medical conditions
You:
Other
You:
This is an international phase 3 trial. Researchers need about 480 people worldwide and 24 people from the UK to join.
It is a randomised trial. The people taking part are put into one of the following groups at random:
Neither you nor your doctor will be able to choose with group you go into. And neither you nor your doctor will know which group you are in. This is called a double blind trial.
How do I have treatment?
You have all drugs as a drip into your bloodstream on set days during the trial. It takes:
Your doctor will tell you whether you have cisplatin or carboplatin.
When do I have treatment?
You have treatment in cycles of treatment that last 3 weeks. You have the first 4 cycles of treatment (about 3 months) in the following way:
After 4 cycles of treatment, you stop having cisplatin and carboplatin. You continue to have pembrolizumab, or the dummy drug, and pemetrexed on day 1 of each cycle of treatment.
You can have up to 35 treatment cycles of pembrolizumab, or the dummy drug, and pemetrexed. It takes about 2 years.
After 2 years, you may be able to continue to have pemetrexed alone. This is called second course treatment. Your doctor can tell you more about this.
If you have the dummy drug and your cancer gets worse, you may be able to cross over to the other group and have pembrolizumab. Your doctor will discuss this with you.
Blood tests and tissue samples
You have extra blood tests as part of this trial. Doctors want to look for:
They will also ask you to have a blood test to study your . Doctors want to find out how genes affect the way people respond to treatment and the side effects they have.
You have the extra blood tests before the start of treatment and at set times during the trial.
Your doctor will ask to use a sample of your cancer taken after your cancer got worse. You need to have a biopsy if there isn’t a suitable sample available. This is so your doctors can find out whether the cancer still has a change in the epidermal growth factor receptors (EGFR).
Quality of life
Everybody taking part completes a quality of life questionnaire before starting treatment and:
The questionnaires ask about how you have been feeling and what side effects you have had.
You see a doctor and have some tests before taking part. These tests might include:
During treatment, you see the doctor every 3 weeks. You have blood tests and a physical examination each time you see them.
You have a CT scan or MRI scan 6 weeks after you start treatment. You then have a CT scan or MRI scan every 9 weeks. This continues for about a year. You then have a CT scan or MRI scan every 12 weeks.
Your treatment continues for as long as your cancer stays the same and the side effects aren’t too bad.
When you finish treatment, you see the trial team after a month. You then see or speak with them every 12 weeks.
The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
The most common side effects of pembrolizumab are:
We have more information about the possible side effects of pembrolizumab.
We also information about the possible side effects of:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Samreen Ahmed
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”