
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called tivantinib (also known as ARQ 197) alongside erlotinib for non small cell lung cancer (NSCLC) that has got worse despite having other treatment. It is for people who have types of NSCLC that are described as non squamous, such as adenocarcinoma or large cell carcinoma.
Doctors may treat advanced lung cancer with drugs called tyrosine kinase inhibitors (TKIs). Tyrosine kinases are proteins that cells use to signal to each other to grow. TKIs block tyrosine kinases which can stop cancer cells growing. But sometimes, lung cancer stops responding to a TKI – (the cancer becomes ).
Erlotinib is a TKI that is already used to treat advanced lung cancer. Everybody taking part in this trial will have erlotinib. Some people will also have a new drug called tivantinib.
Tivantinib is also a TKI, but it targets a different protein called cMET. Doctors hope it may help people with non small cell lung cancer.
The aim of the trial is to see if a combination of erlotinib and tivantinib helps people with advanced NSCLC more than erlotinib alone.
You may be able to enter this trial if you
You cannot enter this trial if you
This is an international phase 3 trial that will recruit about 1,000 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
Erlotinib and tivantinib are tablets that you take every day. You take tivantinib (or the dummy drug) in the morning and the evening with food. You take erlotinib in the morning at least 1 hour before food or at least 2 hours after eating.
You have 4 week cycles of treatment. The length of time you have treatment will depend on how much it helps you. But most people will have between 3 and 6 cycles of treatment, lasting between about 3 and 6 months.
The trial team will ask you to fill out some questionnaires before you start treatment, once every 4 weeks during treatment and when you finish treatment. The questionnaires will ask what you think about your lung cancer, how you are feeling and any side effects you have had. This is called a quality of life study.
The researchers will take some extra blood samples during the trial to learn more about what happens to tivantinib in your body. This is called . They will also use a blood sample to study your genes. They want to see how genes affect the way people respond to tivantinib and the side effects they have. This is called pharmacogenomics.
You will see the trial doctors and have some tests before you start treatment. The tests include
The trial team will get a sample of tissue that was removed when you had surgery or a . If this tissue has already been tested, these results may be requested and can be used for this study. If there is not a sample available, they will ask you to have a biopsy at this time.
You go to hospital once a week for the first 4 weeks and once every 2 weeks for the rest of the time you have the trial treatment. You have blood tests at each visit and an ECG at least once in each cycle of treatment. You have a CT or MRI scan in the 3rd cycle of treatment and then every 8 weeks.
When you finish the treatment, you go back to see the trial team a few weeks later. They may ask you to have another biopsy at this time but this is completely voluntary and they will ask you to sign another . If your last scan was more than 8 weeks ago, you may be asked to have another one. Depending on how much the treatment helped you, the trial team may ask you to have follow up appointments and scans every 12 weeks until your cancer starts to grow again. Or they may phone to see how you are every 12 weeks until the trial has completely finished.
As tivantinib is a new drug, there may be side effects we don’t know about yet. The side effects that are known include
The most common side effects of erlotinib are skin rash and diarrhoea. If either of these are very bad and cannot be controlled with other medication, the trial doctors can reduce your dose of erlotinib. Or, you may need to stop taking it for a while. There is more information about erlotinib on CancerHelp UK.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Conrad Lewanski
ArQule Inc
Daiichi Sankyo
Experimental Cancer Medicine Centre (ECMC)
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”