
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is looking at osimertinib after surgery for non small cell lung cancer (NSCLC).
It is for people who have:
Surgery is a common treatment for non small cell lung cancer. Some cancer cells have changes in particular genes and proteins. For example, a change in the epidermal growth factor receptor (EGFR) gene. If your lung cancer cells have these receptors it is called EGFR positive.
Doctors are looking for ways to improve treatment for early NSCLC that is EGFR positive. In this trial they are looking at a drug called at osimertinib.
Osimertinib is a type of called a cancer growth blocker. It works by targeting a protein called epidermal growth factor receptor (EGFR). It stops signals that cancer cells use to divide and grow.
Osimertinib is already a treatment for cancer that has spread elsewhere in the body. Researchers now want to see how well it works for smaller non small cell lung cancers to stop them coming back after surgery.
In this trial some people have osimertinib and some have a dummy drug ().
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 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 can’t join this trial if any of these apply. You:
This phase 3 trial is taking place worldwide. The team need to find 380 people to take part including 10 from the UK.
Surgery
Everyone has surgery as planned. This is part of your routine care. Your doctor can tell you more about the type of surgery you will have. They can also tell you how long you’ll be in hospital for and how long it will take to get better.
Trial treatment
The treatment part is randomised. There are 2 treatment groups. 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.
You have 1 of the following:
Samples for research
The trial team ask you to give some extra blood samples. Where possible you have these at the same time as your routine blood tests.
They will also ask to look at samples of the cancer from your surgery. They might ask you to give a new sample if your cancer comes back.
The researchers plan to use the samples to:
Quality of life
The trial team ask you to fill out a questionnaire:
You complete these on an electronic device like an I-pad or on your phone. 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:
During treatment you see the trial doctor for a check up and blood tests at:
Each visit takes between 1 and 3 hours. You have a CT scan every 6 months for up to 5 years.
Follow up
If your cancer hasn’t come back you have a check up every:
The trial visits and scans stop if your cancer comes back (recurs). Your doctor will talk to you about other treatment options. The trial team then call you every 6 months to see how you are.
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.
The most common side effects of osimertinib include:
The trial doctor will talk to you about all the possible side effects of treatment.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Laura Cove-Smith
AstraZeneca
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”