
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the combination of olaparib and pembrolizumab for non small cell lung cancer that has spread.
Non small cell lung cancer that has spread is called advanced non small cell lung cancer.
To treat advanced NSCLC you might have either:
These are chemotherapy drugs.
Your doctor might suggest you also have an drug called pembrolizumab. It works by stimulating the
to fight cancer.
Olaparib is a called a cancer growth blocker. It works by blocking a certain protein called PARP that cells need to divide and grow.
Researchers think that the combination of olaparib and pembrolizumab might work well for advanced NSCLC.
In this trial there are 2 parts. In the 1st part (induction) everyone has pembrolizumab with pemetrexed and carboplatin or cisplatin.
In the 2nd part (maintenance) half the people have pembrolizumab and pemetrexed. And the other half have pembrolizumab and olaparib.
The aims of this trial are to compare:
To find out if:
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:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The trial team need 729 people worldwide to join with 34 people from the UK.
There are 2 parts to this trial. The 1st is the induction part. The 2nd is the maintenance part.
Induction
In this part everyone has pembrolizumab with:
Your doctor decides which combination you have.
This is a standard treatment for advanced NSCLC.
Pembrolizumab is an immunotherapy drug. Pemetrexed, carboplatin and cisplatin are chemotherapy drugs. You have all these as a drip into a vein.
You have them once every 3 weeks. Each 3 week period is. You have 4 cycles of treatment.
Maintenance
You see your doctor after finishing the induction. You can continue into the maintenance part if:
This part is a randomised trial. You are put into 1 of 2 treatments groups. You or your doctor can’t choose which group you are in. The groups are:
You have pembrolizumab for about 2 years (35 cycles of treatment) as long as it is working and the side effects aren’t too bad.
You continue to have pemetrexed as long as it is working and the side effects aren’t too bad.
Olaparib is a tablet. You take it twice a day. Your doctor tells you how many to take.
You continue having treatment as long as it is working and the side effects aren’t too bad.
Quality of life
You fill in a few questionnaires:
The questions are about:
These are quality of life questionnaires.
Samples
You give tissue samples during the trial. Researchers use these samples to:
The team will also ask your permission to store these samples to use them for future research. You don’t have to agree to this. You can still take part in the trial.
You see the doctor to have some tests before you take part in the trial. These tests include:
Induction
During the induction part you see the doctor every 3 weeks for blood tests and to see how you are. You have a CT scan or MRI scan every 6 weeks.
After the induction part you see the doctor for blood tests and to see how well the treatment worked. You can go into the maintenance part if:
If you don’t go into the maintenance part you have:
You then have a scan every 6 weeks for 60 weeks then every 9 weeks until your cancer starts to grow again or you start another treatment.
A member of the trial team phones you every 3 months to see how you are.
Maintenance
During the maintenance part you see the doctor every 3 weeks for blood tests and to see how you are. You have a CT scan or MRI scan every 6 weeks to 60 weeks and then every 9 weeks.
A month after finishing treatment you see the doctor for:
You then have a scan every 6 weeks for 60 weeks then every 9 weeks until your cancer starts to grow again or you start another treatment.
A member of the trial team phones you every 3 months to see how you are
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.
You have a card that has contact details of the trial team. Carry this with you all the time and give it to the doctor or nurse if you go to the hospital or GP. So they can contact the team if they need to.
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:
We have more information about pembrolizumab and its side effects.
The most common side effects of olaparib include:
We have more information about olaparib and its side effects.
We have information about:
Your doctor or a member of the trial team will talk to you about the possible side effects of the drugs used in this trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Shobhit Baijal
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”