A trial of chemoradiotherapy, pembrolizumab, and olaparib for small cell lung cancer (KEYLYNK-013)

Cancer type:

Lung cancer
Small cell lung cancer

Status:

Open

Phase:

Phase 3

This trial is looking at adding a drug called pembrolizumab to chemoradiotherapy for newly diagnosed small cell lung cancer. It is also looking at having pembrolizumab on its own or with olaparib after chemoradiotherapy.

It is for people who:

  • haven’t had treatment for small cell lung cancer and 
  • whose cancer is in only one lung. This is called limited small cell lung cancer.

More about this trial

You might have a combination of radiotherapy and chemotherapy to treat small cell lung cancer that hasn’t spread. This is called chemoradiotherapy. It is a standard treatment for some people with limited small cell lung cancer.  

Doctors are looking for ways to improve treatment for this group of people. They think that adding 2 drugs called pembrolizumab and olaparib may help. 

Pembrolizumab is a type of immunotherapy. It helps your immune system Open a glossary item to find and kill cancer cells. It is already a treatment for another type of lung cancer and for small cell lung cancer that has spread.  

Olaparib is a type of targeted cancer drug called a PARP inhibitor Open a glossary item. It blocks an enzyme called PARP which helps damaged cells to repair themselves. 

The main aims of the trial are to find out:

  • if it is safe to have pembrolizumab and olaparib for limited stage small cell lung cancer
  • if having pembrolizumab and olaparib improves treatment
  • more about the side effects of treatment
  • what happens to olaparib and pembrolizumab in the body
  • how treatment affects quality of life

Who can enter

The following bullet points are a summary of 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 limited small cell lung cancer that is newly diagnosed
  • have cancer that is contained in a single area on one side of the chest and it can be treated with radiotherapy
  • have cancer that the doctor can measure on a scan
  • have a sample of cancer tissue (biopsy Open a glossary item or fluid sample) available for the trial team to do some tests on or you are willing to give a new sample
  • are well enough to carry out all your normal activities 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 the trial and for a certain period of time after if there is any chance you or your partner could become pregnant
  • are at least 18 years old 

Who can’t take part

Cancer related 
You cannot join this trial if any of these apply. 
You:

  • have cancer that has spread to other parts of the body or it isn’t possible to have radiotherapy to treat it
  • have had treatment for lung cancer. This includes having chemotherapy, radiotherapy or surgery.
  • need surgery to remove the cancer during the trial
  • might need to have a large dose of radiotherapy
  • have had an immunotherapy Open a glossary item in the past
  • have already had olaparib or another PARP inhibitor Open a glossary item in the past
  • might need another cancer treatment while you are on this trial
  • have had treatment to boost the number of blood cells in your body within 28 days of starting trial treatment
  • have or had a type of blood cancer called acute myeloid leukaemia Open a glossary item or myelodysplastic syndrome Open a glossary item
  • are taking an experimental treatment or using a device as part of a clinical trial in the 4 weeks before joining this trial
  • have another cancer that is getting worse or needed treatment in the past 5 years. You can join if you have non melanoma skin cancer Open a glossary item, early bladder cancer or CIS Open a glossary item that has been successfully treated.

Medical Conditions
You cannot join this trial if any of these apply. 
You:

  • have a problem with how your lungs work
  • have a heart problem Open a glossary item that needs treatment, an abnormal heartbeat or you had a heart attack in the last 3 months
  • have had a problem with seizures (fits) in the last 3 months
  • have lost more than 10% of your body weight in the 3 months before you join the trial
  • have spinal cord compression Open a glossary item that needs treatment 
  • have a blockage in a major blood vein in your upper body (superior vena cava obstruction Open a glossary item)
  • have a problem with how your immune system Open a glossary item works or you are taking medication to damp down the immune system unless it is a low dose
  • have an autoimmune condition Open a glossary item that needed treatment in the last 2 years apart from certain ones
  • have scarring on the lungs or active inflammation of the lungs (pneumonitis Open a glossary item) that is not caused by an infection
  • have had major surgery in the 4 weeks before starting treatment in this trial 
  • have HIV, an active hepatitis B or hepatitis C infection or you have another infection that needs treatment 
  • have a problem with your nerves caused by cancer. This can cause problems with coordination, changes to your senses, memory or thinking skills, or sleep problems. Your doctor will know about this.
  • can’t swallow medication or you have a problem with your digestive system Open a glossary item that affects how you absorb medication
  • have had a stem cell transplant with somebody else’s cells Open a glossary item or you had an organ transplant Open a glossary item in the past 
  • are taking medication that affects the CYP enzymes
  • have any other medical condition or mental health problem that 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 item within a month of starting trial treatment. This doesn’t include the approved COVID-19 vaccines as they aren’t live.
  • have a problem with drugs or alcohol
  • are allergic to treatments in this trial or anything they contain
  • are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The trial team need 672 people to take part. 

It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor can decide which group you are in. Nor will you know which group you are in. The trial doctor can find this out if necessary. 

There are 3 groups. You have one of the following:

  • dummy (placebo Open a glossary item) pembrolizumab and chemoradiotherapy. This is followed by dummy pembrolizumab and dummy olaparib. (Group 1)
  • pembrolizumab and chemoradiotherapy. This is followed by pembrolizumab and dummy olaparib. (Group 2)
  • pembrolizumab and chemoradiotherapy. This is followed by pembrolizumab and olaparib. (Group 3)

Chemotherapy and radiotherapy (standard treatment)
To begin with, everyone has chemotherapy and radiotherapy. 

You have chemotherapy every 3 weeks. Each 3 week period is a cycle of treatment Open a glossary item.

Day 1 is the first day of the treatment cycle. In each cycle you have:

  • cisplatin or carboplatin on day 1 (your doctor decides which drug they think is best for you)
  • etoposide on day 1, day 2 and day 3 

You have chemotherapy as a drip into a vein. You have it for up to 12 weeks in total.  

You have radiotherapy from Monday to Friday. You start this when you begin your second cycle of chemotherapy. You have either:

  • radiotherapy once a day, Monday to Friday for 6 ½ weeks or 
  • radiotherapy twice a day Monday to Friday for 3 weeks

Your doctor will talk to you about the schedule of radiotherapy they think is best for you.  Before your radiotherapy starts you have a planning appointment.

Chemotherapy and radiotherapy take up to 4 months in total. 

Pembrolizumab with chemoradiotherapy 
During chemoradiotherapy you also have pembrolizumab or the dummy pembrolizumab. You have this as a drip into a vein once every 3 weeks. You have it for up to 12 weeks in total.   

Radiotherapy to the brain
Small cell lung cancer can spread to the brain. After radiotherapy and chemotherapy your doctor might suggest that you also have radiotherapy to the brain. This is to reduce the risk of cancer spreading there. The team can tell you more about this if you have this treatment. It is a standard treatment Open a glossary item you might have even if you weren’t in this trial. 

Pembrolizumab and olaparib after chemoradiotherapy 
After chemoradiotherapy you have pembrolizumab or the dummy pembrolizumab. You have this once every 6 weeks. You have it for up to a year as long as the cancer does not get worse and the side effects aren’t too bad. 

You also have olaparib or the dummy olaparib. Olaparib is a tablet. You take it twice a day, every day. You have it for up to a year as long as the cancer does not get worse and the side effects aren’t too bad. 

Samples for research
The researchers ask for a sample of cancer tissue from a previous biopsy Open a glossary item. You may need to give a new sample if there isn’t one available. The team also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to use the samples to:

  • see how well the treatment is working
  • look at genes Open a glossary item to understand more about small cell lung cancer
  • look for substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others
  • see what happens to pembrolizumab and olaparib in the body

Quality of life 
The trial team ask you to fill out a questionnaire:

  • before you start treatment
  • at set times during treatment

The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor and have tests before you can take part. These include:

You might also have a hearing test if you have cisplatin.

You have chemotherapy and pembrolizumab or the dummy pembrolizumab in the hospital day care ward. You also have radiotherapy at the hospital. 

You see the doctor regularly during treatment. This is to see how you are and for blood tests.

Trial scans
You have a CT scan or MRI scan 12 weeks after you start chemotherapy. You then have the scans every:

  • 9 weeks until the end of the second year of the trial
  • 3 months in the 3rd year 
  • 4 months in the 4th year 
  • 6 months in the 5th year of the trial and then
  • once a year after that

You stop having the trial scans if your cancer gets worse. The team will talk to you about other treatment options.

Follow up
When you finish treatment, you see the trial doctor a month later for a check up. You then see them regularly to see how you are. If your cancer gets worse or you start another cancer treatment the team call you every 3 months to see how you are getting on. 

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. 

Pembrolizumab can affect the immune system. Open a glossary item This may cause inflammation Open a glossary item and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects.

These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.

If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

 

Pembrolizumab and olaparib are new treatments for limited small cell lung cancer. So there may be some side effects we don’t know about yet.

The common side effects of pembrolizumab include:

  • itchy skin or skin rash
  • diarrhoea
  • cough
  • joint pain
  • high temperatures (fever)
  • back pain or stomach pain
  • loss of skin colour
  • low levels of thyroid Open a glossary item hormone. You may feel tired, gain weight, feel cold, or have constipation.
  • low levels of salt in the blood. This may cause you to feel tired, confused, have a headache, have muscle cramps, feel or be sick.

The most common side effects of olaparib include:

Please note you should avoid grapefruit, grapefruit juice, Seville orange juice, and St. John’s Wort while you are having pembrolizumab or olaparib. 

We have more information about:

We also have information about:

The trial doctor will talk to you about the possible side effects of all the treatments before you agree to take part.

Location

Dundee
London
Manchester

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 Daniel Smith

Supported by

Merck, Sharp & Dohme

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17461

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

Last reviewed:

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