Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at different drugs for non small cell lung cancer (National Lung Matrix Trial)
This trial is looking at a number of new drugs to treat non small cell lung cancer. The treatment you have depends on changes to genes in your cancer cells.
The trial is supported by Cancer Research UK.
More about this trial
Non small cell lung cancer (NSCLC) is the most common type of lung cancer. There are 2 main types of NSCLC called squamous cell carcinoma and adenocarcinoma. This trial is for people who have one of these types of NSCLC, and surgery or radiotherapy aren’t suitable treatments for them.
Doctors decide how to treat a cancer by looking at:
- what type of cancer it is
- where it is in your body
- the size of the cancer
- what the cancer cells look like
This works for many people but not for all. This could be because there are slight differences in the cancer cells from person to person, even if they have the same type of cancer. This is particularly true of lung cancer, where changes to genes in the cancer cells are different from person to person. Genes are coded messages that tell cells how to behave. If a gene is changed it can allow cancer cells to grow.
Identifying the gene changes will allow doctors to specifically target them and try to kill the cancer cells, or stop them growing. Matching treatment to genetic changes in cancer cells is called stratified medicine.
The people taking part in this trial have already agreed to have their cancer tested to look for any gene changes as part of the Cancer Research UK Stratified Medicine Programme (SMP2). They now have treatment depending on the gene changes found in their cancer cells. The researchers want to:
- see how well the treatments work and how safe they are
- understand more about which genetic changes are linked to
drug resistanceand why some people benefit from treatment but others do not
Who can enter
You may be able to join this trial if all of the following apply. You:
- have non small cell lung cancer that is either squamous cell carcinoma or adenocarcinoma
- have cancer that has spread outside your lung (stage 3) and you can’t have surgery or radiotherapy with the aim of curing it, or it has spread to another part of your body (stage 4)
- have had all other
standard treatmentsthat are suitable for you and your cancer has continued to grow
- gave a sample of your tumour in the Cancer Research UK Stratified Medicine Programme (SMP2)
- have had a CT scan or MRI scan in the last 4 weeks that shows an area of cancer that can be measured
- are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1). Depending on which treatment group you are in you may be able to take part if you are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- have satisfactory blood test results
- are at least 18 years old
- are willing to use reliable contraception during the trial and for at least 3 months after you finish treatment if there is any chance you or your partner could become pregnant. Depending on which treatment you have, you may need to use contraception for longer than 3 months afterwards (the trial team will advise you about this)
You cannot join this trial if any of these apply. You:
- have cancer that has spread to your brain or is pressing on your spinal cord (spinal cord compression), unless this has been treated, is not getting worse or causing any symptoms, and you haven’t needed to take
steroidsfor at least 4 weeks
- have had major surgery,
chemotherapyor radiotherapy, or any other anti cancer treatment (including experimental drugs) in the last 4 weeks
- have any long term problems with your
digestive systemthat could affect how you absorb drugs
- have had any other cancer in the last 3 years apart from carcinoma in situ of the cervix or basal cell skin cancer that was successfully treated
- are still having side effects from earlier cancer treatment unless they are very mild (apart from hair loss)
- have HIV, hepatitis B or hepatitis C
- have certain heart problems (the trial team can advise you about this as it will depend on which treatment you have)
- have any other medical condition or mental health problem that the trial team think could affect you taking part
- are pregnant or breastfeeding
There are some other things that would mean you can or can’t join different treatment groups in the trial (the trial team can advise you about this).
This is a phase 2 trial. The researchers want to screen about 2,000 people. They hope that about 610 of them will be able to join the trial.
The people taking part are put into treatment groups according to gene changes that have been identified in their cancer cells. At present there are only a limited number of drugs available which can be matched to an individual gene change.
If one of these gene changes has been found in your cancer cells, you are put into one of the following groups:
- people in group A have a drug called AZD4547
- people in group B have a drug called vistusertib (AZD2014)
- people in group C have a drug called palbociclib
- people in group D have a drug called crizotinib
- people in group E have a drug called selumetinib and a chemotherapy drug called docetaxel
- people in group F have a drug called AZD5363
- people in group G had a drug called osimertinib - this group is now closed to recruitment
- pleople in group H have a drug called sitravatinib
If you don’t have a gene change that can be matched to a drug, you will be in a group called NA:
- people in group NA had a drug called durvalumab (MEDI4736) - this group is now closed to recruitment
There is no evidence that the activity of durvalumab is dependent upon the presence of any specific gene changes.
As the trial goes on, the research team may identify other drugs that they think could work for people with certain genetic changes. If that happens, they will add new groups.
The trial team will give you more information about the treatment you are going to have. They will also explain how and when you have the treatment and how long it will last.
You see the trial team and have some tests before you start treatment. The tests include:
- physical examination
- blood tests
- urine test
- heart trace (
- a test to measure the amount of carbon monoxide in your breath
- CT scan
Depending on which treatment group you are in, you may also have:
- a heart scan (
MUGA scanor echocardiogram)
- an eye examination
The researchers will need to test a sample of your cancer before you can take part in the trial. There may be enough tissue left from the sample you gave for the SMP2 study. But if there isn’t enough tissue left after the tests that were done, or you have had certain types of treatment since giving that sample, you will need to have a new biopsy that the researchers can test.
It is possible to get important information from tiny amounts of cancer related material in your bloodstream. This is known as circulating tumour DNA or ctDNA. It is possible to track how your cancer changes over time by looking at changes to the ctDNA before, during and after treatment. It may also be possible to identify which changes are linked to
The trial team will also ask you to have a biopsy before starting treatment and another when you finish treatment. This is to help them understand more about why some people benefit from treatment and others do not. But you don’t have to agree to have these 2 extra biopsies if you don’t want to. You can still take part in the trial.
How often you go to hospital for treatment will depend on which group you are in. You have a CT scan every 6 weeks during treatment for the 1st year. You then have a CT scan every 12 weeks.
The trial team will tell you more about the hospital visits you will need to make, and any tests you will have during the trial and after you finish treatment.
As some of the drugs being looked at in this trial are new, there may be side effects we don’t know about yet.
The trial team will talk to you about all the possible side effects of the drug (or drugs) you will be having before you agree to take part.
How to join a clinical trial
Professor Gary Middleton
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
University of Birmingham