
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at whether amivantamab with lazertinib is better than osimertinib by itself or lazertinib by itself for non small cell lung cancer.
It is open to people with non small lung cancer (NSCLC) that has spread into the nearby tissue () or to another part of the body (advanced). It is only for people whose cancer has a
change (
in the epidermal growth factor receptor (EGFR).
Amivantamab is a called a monoclonal antibody. It works by attaching to different proteins on cancer cells and blocking them. One protein is EGFR.
Osimertinib and Lazertinib are targeted drugs called TKI growth inhibitors. They work by attaching to EGFR that have certain gene changes (mutations) and blocking them.
Blocking EGFR can stop or slow down the growth of NSCLC.
Doctors already use amivantamab for NSCLC that has spread to nearby tissue or another part of the body. They also use osimertinib for NSCLC that has spread to another part of the body.
Researchers think that combining amivantamab with lazertinib might be better than osimertinib by itself or lazertinib by itself.
In this trial you have either:
The 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 is an international phase 3 trial. The team need about 1,000 people to join with 11 people from the UK.
This is a randomised trial. A computer puts you into a group. Neither you nor your doctor chooses which group you are in.
There are 3 groups:
People in group A and their doctors know what treatment they are having. This is an open label trial group.
People in group B and group C and their doctors don’t know what treatment they are having. These are groups. But your doctor can find out what treatment you are having if necessary.
For every 5 people joining the trial 2 go into group A, 2 into group B and 1 into group C.
You have amivantamab as a drip into a vein. You have it once a week for 4 weeks and then every 2 weeks.
Lazertinib, osimertinib and the dummy drugs are tablets. You take them once a day every day. Your doctor will tell how many to take and how often.
You continue treatment as long as it is working and the side effects aren’t too bad.
Quality of life
You fill in questionnaires before you start treatment and then:
The questions ask about your general health and wellbeing.
You complete the questionnaires on a smart phone or tablet.
These are quality of life questionnaires.
Research samples
You give extra blood samples as part of the trial. Where possible the team take these when you have your routine bloods.
The team ask for a piece of a tissue sample () you had previously. If this is not available you must agree to have a new tissue sample taken. They will also ask for another tissue sample when you finish treatment.
They will use these samples to learn more about lung cancer and treatment for it.
You see the doctor to have tests before taking part. These include:
You see the doctor at regular times during treatment to see how you are and for blood tests.
You see the doctor at the end of treatment and then every 3 months for 3 years.
You have a scan every 8 weeks for 2½ years and then every 3 months until your cancer gets worse.
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.
Combining amivantamab with lazertinib is new and there might be side effects we don’t know about yet. The side effects that have been reported are:
The common side effects of osimertinib are:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Martin Forster
Janssen
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.