
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at a new drug called MK-7684A with chemotherapy to treat small cell lung cancer.
It is for people whose cancer has spread within the chest or to other parts of the body. This is called extensive disease.
You may have chemotherapy and atezolizumab as the first treatment for extensive small cell lung cancer.
The usual chemotherapy drugs you might have as your first treatment are carboplatin and etoposide. Atezolizumab is an immunotherapy. It helps your to find and kill cancer cells.
Researchers are looking at ways to improve treatment. In this trial they are looking at a new drug called MK-7684A with chemotherapy. MK-7684 is made up of 2 drugs called MK-7684 and pembrolizumab. They are both types of immunotherapies.
In this trial some people have MK-7684A and chemotherapy. And some have atezolizumab and chemotherapy.
The main aims of the trial are to find out:
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:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. 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 phase 3 trial is taking place worldwide. The team need to find 450 people to take part including 6 from the UK.
It is a randomised trial. A computer puts you into a group. Neither you nor your doctor will be able to decide which group you are in. Nor will you know which group you are in. The trial doctor can find this out if necessary.
Trial treatment
There are 2 treatment groups. You have 1 of the following:
You have treatment every 3 weeks. Each 3 week period is a . On the first day of each cycle you have the following:
You also have etoposide on day 2 and day 3.
You have all your treatment as a drip into a vein. You have chemotherapy for up to 12 weeks in total.
You have MK-7684A or atezolizumab for as long as it is working and the side effects aren’t too bad. They take about an hour the first time you have them. After that they take about 30 minutes each time.
You stop trial treatment if your cancer gets worse. Your doctor will talk to you about other treatment options if this happens.
Research samples
You give extra blood samples as part of the trial. Where possible the team take these when you have your routine blood tests.
The team ask for a piece of a tissue sample ( you had previously. You must agree to give a new tissue sample if there isn’t one available.
They will use these samples to:
Quality of life
The trial team ask you to fill out a questionnaire on an electronic device:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have tests before you can take part. These include:
You might have a hearing test if you have cisplatin.
You have all your treatment at the hospital on the day care ward. Each visit takes between 2 and 5 hours.
Trial scans
You have a CT or MRI scan of the pelvis, chest and abdomen (tummy area):
You also have a CT or MRI scan of the brain every:
You stop having scans as part of the trial if your cancer gets worse.
Follow up
When you finish treatment you see the trial doctor a month later for a check up. They continue to follow you up every 3 months to see how you are. This might be at a routine hospital appointment or they might call you.
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.
MK-7684A and atezolizumab can affect the immune system. It may cause inflammation in different parts of the body. This 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. 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. |
MK-7684A is a new drug so there might be side effects we don’t know about yet. The side effects we know about so far include:
The trial team will talk to you about the side effects of all the treatments before you join the trial. You’ll have a chance to ask any questions you may have.
We have information about the following drugs and their side effects:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Raffaele Califano
Merck Sharp & Dohme LLC
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.