A trial of pembrolizumab and chemotherapy for small cell lung cancer (KEYNOTE-604)

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

Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is looking at pembrolizumab and chemotherapy for people with small cell lung cancer that has spread outside the lung (extensive stage).

It is for people who are going to have treatment for the first time.

More about this trial

Small cell lung cancer (SCLC) can sometimes spread to the lymph nodes outside the lung or into other parts of the body. This is extensive stage disease.

Treatment for extensive stage SCLC is usually a combination of chemotherapy drugs. You have a combination of chemotherapy drugs because they tend to work better than single drugs. You often have etoposide with either:

This combination works but researchers are looking for ways to improve treatment. In this trial, they are looking at a targeted cancer drug called pembrolizumab (Keytruda).

Pembrolizumab blocks a protein called PD-1. Doctors think it can help the immune system Open a glossary item to recognise and attack cancer cells.

Everyone taking part in this trial has 1 of the following:

chemotherapy and pembrolizumab
chemotherapy and a dummy drug (placebo)

The main aims of this trial are to:

find out how well pembrolizumab and chemotherapy work together as a treatment
learn more about the side effects
learn about people’s quality of life
find out what happens to pembrolizumab in the body (pharmacokinetics)

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 a newly diagnosed extensive stage SCLC (stage 4)
have at least 1 area of cancer that can be seen and measured on a scan
are willing to have a sample of tissue taken (a biopsy) if there isn’t a suitable sample available. Your doctor will check for this
have satisfactory blood tests results
are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
are at least 18 years old
are willing to use reliable contraception during treatment and for 4 months after the final dose of pembrolizumab or 6 months after the last dose of chemotherapy if there is any possibility you or your partner could become pregnant

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

you have had treatment for SCLC, unless it was radiotherapy to help with symptoms (palliative radiotherapy) that you have finished more than a week ago
your doctor thinks you will need other cancer treatments (including radiotherapy) during this trial
you have had pembrolizumab before or any other similar drugs
your cancer has spread to your brain unless you have had treatment more than 2 weeks ago, it hasn’t got worse in the past 3 weeks and you haven’t taken steroids in the last week
you have had another cancer apart from carcinoma in situ of the cervix and breast, basal or squamous cell skin cancer that have been successfully treated

Medical conditions

you have had an experimental treatment as part of another clinical trial in the past month
you have had a major surgery in the past 3 weeks and you still have side effects from it
you have, or have had, certain lung problems such as inflammation of the lungs (pneumonitis) or interstitial lung disease
you have or have had an autoimmune disease that needed systemic treatment in the past 2 years, apart from treatment to replace something that the body makes such as insulin or thyroxine
you have, or have had, problems in the brain or nerves that are caused by substances released by the cancer (neurological paraneoplastic syndrome)
you have problems with your bowels such as inflammation (diverticulitis), an abscess or a blockage (obstruction)
you are sensitive to monoclonal antibodies , pembrolizumab or anything it contains
you have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past week unless it was a cream or inhaler
you have a build up of fluid in your tummy (ascites) or between the sheets of tissue that cover the lung (pleural effusion) and this is causing you problems
you have had a live vaccine in the last month
you have an infection that needs treatment
you have HIV
you have hepatitis B or hepatitis C
you have tuberculosis
you have any other serious medical condition or mental health problem that the trial team thinks could affect you taking part

Other

you are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need about 430 people worldwide and around 18 people from the UK to take part.

This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

chemotherapy and pembrolizumab
chemotherapy and dummy drug

Neither you nor your doctor are able to decide which group you are in. And neither you nor your doctor will know which treatment you are having. This is a double blind trial Open a glossary item .

(KEYNOTE-604)

Pembrolizumab
Everyone has pembrolizumab or the dummy drug as a drip into a vein every 3 weeks. Each 3 week period is called a cycle of treatment.

You continue to have cycles of treatment of pembrolizumab or the dummy drug for as long as it is helping you and the side effects aren’t too bad. You can have treatment for up to 2 years.

After 2 years, you may be able to continue having pembrolizumab. This is called second course phase. Your doctor can tell you more about this.

Chemotherapy
You have a combination of 2 drugs:

etoposide
cisplatin or carboplatin (your doctor will explain which drug is best for you)

You have all drugs as a drip into a vein. You come into hospital and have etoposide on days 1, 2 and 3 of each cycle of treatment. It takes around an hour each day you have it.

You have cisplatin or carboplatin once, every 3 weeks. This continues for 12 weeks. It can take up to 2 and a half hours each time you have it.

After you finish chemotherapy, you have a scan to find out how well the treatment has worked. Then you may have radiotherapy to the brain if your cancer got smaller or disappeared. This is called prophylactic cranial irradiation (PCI). Your doctor can tell you more about this.

Quality of life
Everybody taking part in this trial completes a quality of life questionnaire before starting treatment and:

at set times during the trial
at the end of treatment
a month after finishing treatment

The questionnaires ask about how you have been feeling and what side affects you have had.

Blood tests
You have extra blood tests as part of this trial. Researchers want to:

look for proteins called antibodies that can attach to pembrolizumab
find out what happens to pembrolizumab in your body

You have the extra blood tests before the start of treatment, at set times during the trial and a month after finishing treatment.

Tissue sample
The trial team will ask to use a tissue sample of your cancer taken when you were diagnosed. You will need to have a biopsy if there isn’t a suitable sample already available.

Researchers want to look for biomarkers Open a glossary item that can help to tell how well the treatment works.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

physical examination
heart trace (ECG)
blood tests
urine test
a CT scan or MRI scan
bone scan

During treatment, you see the trial doctor for blood tests and a physical examination every 3 weeks.

You have a CT scan or MRI scan every 6 weeks while you are having treatment. This continues for a year. After this, you have a CT scan or MRI scan every 9 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. The trial team will then call you every 8 weeks to see how you are.

Side effects

The trial team monitor you during the time you have treatment and 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: