
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 study is looking at lorlatinib for non small cell lung cancer (NSCLC) that has a change in a
called anaplastic lymphoma kinase (ALK). This is called ALK positive disease.
It is open to people whose cancer got worse during treatment with one of the following:
If you are still having treatment with one of the above and it is still working you may be able to join a that is part of this study.
Doctors use called
such as ceritinib, alectinib and brigatinib to treat NSCLC that has an ALK gene change.
Sometimes treatment can stop working because the cancer develops more gene changes. In this study researchers want to find out if this has happened in your cancer and if so what these new changes are.
The standard way of finding this out is by taking a sample of the cancer tissue (). There are 2 main ways to take a biopsy. The first is using a needle (needle biopsy). The doctor puts a needle through the skin into the lung where the cancer is. They take out a small piece of the cancer tissue using the needle.
The second is a surgical biopsy. The doctor takes a biopsy during an operation.
In this study the team are looking at another way of looking for these gene changes. This is by taking blood samples and looking for gene changes in the blood. This is called (ctDNA). These are tiny bits of
of the cancer cells that are in the blood after the cancer cell has died.
As part of the study you take lorlatinib. This is also a growth blocker. Doctors already use this to treat NSCLC with an ALK gene change.
The main aims of the study are to find out:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This is an international phase 2 study. The team need 84 people to join the study.
Main study
Everyone in the main study has lorlatinib.
Lorlatinib is a tablet. You take it once a day. You continue taking lorlatinib as long as it is helping and the side effects aren’t too bad.
Sub study
You can join the if you are still having treatment with:
And your treatment is still working.
While your treatment is working you won’t have lorlatinib. But if your cancer starts to grow again while on treatment your doctor might invite you to take part in the main study.
Samples for research for the main study and sub study
You give blood samples when you join then every 3 months while having treatment. Where possible, the team will take these samples when you have blood samples taken as part of your routine care.
You give another blood sample if your cancer comes back while having lorlatinib.
Researchers will use these samples to look at specific changes in ALK and other genes. They want to find out how gene changes affect the way the treatment works.
They are also looking at whether there is enough genetic information such as (ctDNA) in the blood samples to show how well treatment is working.
Optional samples for research for the main study
Using blood samples is a new way of checking how well treatment is working. So the team want to check that the information is the same as the standard way of checking. The standard way is to take samples of tissue () from the cancer.
The team will ask you for 2 tissue biopsies. The first is before you start lorlatinib. The second is if and when your cancer starts to grow.
Your doctor will make sure it is safe to take a biopsy before taking them.
The team will check the information taken from the blood samples with the information from the biopsies. They hope this can help them decide how to best use these blood samples. And whether blood samples can replace biopsies to check how well treatment is working.
You don’t have to agree to have the biopsies taken. You can still take part in the main study.
Quality of life
As part of the main study you fill in a questionnaire. You fill it in before starting lorlatinib and at regular times during the first year of treatment.
The questions ask about:
This is a quality of life questionnaire.
Main study
You see the doctor for tests before taking part. These include:
During treatment you see the doctor regularly. This is for blood tests and to see how you are.
You have the same scan you had at the start and an MRI of your brain:
At the end of treatment you see the doctor for tests, blood tests and to see how you are.
You then see the doctor:
If your cancer gets worse while having lorlatinib, you see the doctor or they will phone every 3 months to see how you are.
Sub study
There are no extra hospital visits if you take part in the sub study.
The study 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 lorlatinib are:
We have more information about lorlatinib.
Your doctor will talk to you about the possible side effects of lorlatinib and answer any questions you have before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Fiona Blackhall
European Organisation for Research and Treatment of Cancer (EORTC)
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.