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:

Lung cancer
Non small cell lung cancer

Status:

Closed

Phase:

Phase 3

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 immunotherapy Open a glossary item drug called pembrolizumab. It works by stimulating the immune system  Open a glossary itemto fight cancer.

Olaparib is a targeted cancer drug Open a glossary item 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 Open a glossary item 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 Open a glossary item) 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 Open a glossary item) 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 Open a glossary item (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) Open a glossary item
  • 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 Open a glossary item or any carcinoma in situ Open a glossary item 
  • 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 Open a glossary item 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 Open a glossary item) 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 Open a glossary item) or fluid on the abdomen (ascites Open a glossary item). 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 Open a glossary item (MDS) or acute myeloid leukaemia Open a glossary item(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 Open a glossary item (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 Open a glossary item or GMCSF Open a glossary itemto help your bone marrow Open a glossary item 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 Open a glossary item) 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 Open a glossary item that means your body can’t absorb the medication 
  • have had an organ transplant Open a glossary item
  • have had a stem cell or bone marrow transplant from another person (allogeneic transplant Open a glossary item)
  • 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  Open a glossary itemwithin 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 a cycle of treatment Open a glossary item. 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 Open a glossary item) 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:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Shobhit Baijal 

Supported by

Merck, Sharp & Dohme

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16682

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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