A trial looking at the combination of a targeted drug and immunotherapy for non small cell lung cancer (KEYLINK-006)
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 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.
More about this trial
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:
- pembrolizumab and olaparib
- pembrolizumab and pemetrexed
To find out if:
- it works better
- the side effects are better
- the
quality of life is better
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) that is a non squamous cell type
- have stage T4 NSCLC that has spread to another part of the body (M1)
- have an area of cancer the doctor can measure
- have a sample of cancer tissue that the trial team can access either from when you were diagnosed or if this isn’t available you have a new sample (
biopsy ) taken - are active but might not be able to do heavy physical work (performance status 0 or 1)
- 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.
Cancer related
You:
- have had treatment that reaches your whole body (
systemic treatment ) for your advanced NSCLC including chemotherapy and targeted drugs. You might be able to join if you had chemotherapy before surgery or radiotherapy to shrink the cancer or you had chemotherapy after surgery or radiotherapy and your cancer spread developed at least a year after this. - have the gene changes (mutation) for EGFR, ALK or ROS1 in your cancer cells
- have cancer that is mostly squamous cell lung cancer
- have cancer that has spread to your brain or spinal cord that is growing or causing symptoms. You might be able to join if your cancer spread isn’t growing or causing symptoms. Or you have treated cancer spread that isn’t growing and there are no symptoms for at least 2 weeks and you haven’t had steroids for at least 3 days before starting treatment
- have had radiotherapy to the lung with a dose of greater than 30
Gray (Gy) within 6 months of starting treatment - have had radiotherapy to relieve symptoms within 7 days of starting treatment. You must also have no ongoing side effects of the radiotherapy and not need to have steroids.
- have had treatment that affects your immune system (
immunotherapy) - have had treatment that affects a protein called PARP (a PARP inhibitor)
- have another cancer that is growing or has grown in the past 3 years and needed treatment apart from successfully treated
non melanoma skin cancer or any carcinoma in situ - are sensitive to any drug used in this trial or any of their ingredients
- are expected to need other any other anti cancer treatment during the trial
Medical conditions
You cannot join this trial if any of these apply. You:
- have an
autoimmune disease that has needed treatment that reaches the whole body in the past 2 years apart from medication that replaces a substance in the body such as insulin, hormones for a thyroid gland that isn’t working well and steroids for adrenal glands or pituitary gland that aren’t working well - have an immune system that isn’t working well or taking a dose of steroids that is more than 10mg per day or any other medication that affects the immune system within 7 days of treatment
- have inflammation of the lungs (
pneumonitis ) or had pneumonitis in the past that needed treatment with steroids - have had a lung disease that affected the tissues of the lung and the space around the air sacs (interstitial lung disease)
- have an active infection that needs treatment that reaches the whole body
- have HIV
- have hepatitis B
- have an active hepatitis C infection
- have active tuberculosis (TB) infection
- have symptoms of having fluid on the lung (
pleural effusion ) or fluid on the abdomen (ascites ). You might be able to join if you have pleural effusion or ascites that isn’t getting any worse (is stable) after treatment for it - have or have signs of the blood cancer
myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) - have had major surgery within 3 weeks of starting treatment
- still have ongoing side effects or complications of major surgery
- are taking a
non steroidal anti inflammatory drug (NSAID) such as aspirin and you can’t stop it apart from a small dose of aspirin for 5 days - are not able or not willing to take folic acid or vitamin B12
- have had treatment such as
GCSF or GMCSF to help your bone marrow make blood cells in the past 28 days before starting treatment - are taking medication that strongly or moderately affects the CYP enzymes
- are taking an experimental drug as part of another clinical trial within 4 weeks of starting treatment. You might be able to join if you are in follow up and have stopped taking the experimental drug for 4 weeks.
- have a heart trace (
ECG ) that shows you have certain heart conditions that medication can’t control or treat well - can’t swallow tablets or capsules
- have a problem with your
digestive system that means your body can’t absorb the medication - have had an
organ transplant - have had a stem cell or bone marrow transplant from another person (
allogeneic transplant ) - have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have had a
live vaccine within 30 days of starting treatment - are pregnant or breastfeeding
Trial design
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:
- pemetrexed and carboplatin or
- pemetrexed and cisplatin
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:
- there is no sign of your cancer (complete response) or it has shrunk (partial response) and
- you have recovered from the side effects apart from hair loss, mild or moderate tiredness or any other mild side effect
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:
- pembrolizumab and olaparib
- pembrolizumab and pemetrexed
You have pembrolizumab and pemetrexed as you did with induction treatment.
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:
- before you start treatment
- at regular times during treatment
- at the end of treatment
The questions are about:
- your general health
- your daily activities
- any symptoms
- any side effects
These are quality of life questionnaires.
Samples
You give tissue samples during the trial. Researchers use these samples to:
- look at the genes in the cancer cells
- look for a substance (
biomarker ) that might tell them how well treatment is working - find out how these drugs affect your body
- find out what happens to these drugs in your body
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.
Hospital visits
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:
- there is no sign of cancer (complete response) or
- the cancer has shrunk (partial response)
If you don’t go into the maintenance part you have:
- blood tests
- heart trace (ECG)
- a CT scan or MRI scan
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:
- blood tests
- heart trace (ECG)
- a CT scan or MRI scan
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
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.
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:
- itching, rash and loss of skin colour
- diarrhoea
- cough
- pain in your joints, back or tummy (abdomen)
- high temperature (fever)
- your thyroid gland not making enough hormone – you might feel tired, gain weight, feel cold and be constipated
- a reduced amount of salt in your blood causing tiredness, confusion, headaches, muscle cramps and feeling sick
We have more information about pembrolizumab and its side effects.
The most common side effects of olaparib include:
- feeling or being sick
- tiredness and feeling weak
- indigestion and heartburn
- loss of appetite and changes to taste
- headache
- dizziness
- diarrhoea
- cough and shortness of breath
- pain in your tummy (abdomen) just below your ribs
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.
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 Shobhit Baijal
Supported by
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
