Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of a monoclonal antibody called LY2875358 for people with non small cell lung cancer that has stopped responding to erlotinib (JTBC)
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 LY2875358 for non small cell lung cancer which has spread to other parts of the body and has got worse despite having a drug called erlotinib. It is for people who have non small cell lung cancer with a change to a gene called MET.
Erlotinib is a type of biological therapy that doctors can use to treat lung cancer. But sometimes erlotinib stops working and the cancer can start to grow again. When this happens doctors say the cancer has become
LY2875358 is a monoclonal antibody. These can seek out cancer cells by looking for particular proteins. In this trial researchers are looking to see if LY2875358 can help people whose cancer has stopped responding to treatment with erlotinib, and if LY2875358 can overcome resistance to the erlotinib.
The aims of this trial are to see
- If having treatment with LY2875358 at the same time as erlotinib can help people whose cancer has started to grow again when taking erlotinib
- If having treatment with LY2875358 on its own can help to treat non small cell lung cancer
Who can enter
You may be able to enter this trial if you
- Have non small cell lung cancer that has spread to another part of your body (stage 4)
- Have lung cancer that has a change to a gene called MET
- Have at least one area of non small cell lung cancer (not in your brain or spinal cord) that can be seen and measured on a scan
- Have non small cell lung cancer that responded well when you started taking erlotinib, but a scan in the last 4 weeks shows that the cancer is now getting worse
- Have not had any other treatment for your cancer since stopping erlotinib
- 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 12 weeks afterwards if there is any chance you or your partner could become pregnant.
- Are able to swallow tablets
You cannot enter this trial if you
- Have taken part in another trial in the last 30 days
- Have taken part in this trial before or have been treated with a drug that works in the same way as LY2875358
- Have symptoms from cancer that has spread to your brain or spinal cord and are taking medication to treat it
- Have had any heart problems in the last 6 months that your doctor thinks would make it unsafe for you to take part in the trial
- Have lung conditions called interstitial pneumonia or interstitial fibrosis and the trial team thinks this would make it unsafe for you to take part in the trial
- Have any other medical condition or mental health problem that trial team think would affect you taking part in this trial
- Have had major surgery in the last 2 weeks
- Have a build up of fluid around the lungs that has needed draining more than once a fortnight
- Have HIV
- Have had any other cancer in the last 3 years apart from non melanoma skin cancer that was successfully treated or very early stage cervical cancer (carcinoma in situ of the cervix)
- Are pregnant or breastfeeding
This phase 2 trial will recruit about 100 people. It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
People in 1 group have LY2875358 alone. People in the other group have LY2875358 and erlotinib. There will be 3 times as many people in the group having LY2875358 and erlotinib as in the group having LY2875358 alone.
You have treatment in 4 week periods called cycles of treatment.
You have LY2875358 as a drip into a vein on the1st and 15th day of each cycle. It takes 1½ hours each time.
If you are in the group having erlotinib, you take it as tablets every day.
You can have treatment
- For as long as it is helping you and your cancer has not grown, or
- Until you decide you don’t want to continue with the trial, or
- Until your trial doctor feels its best for you to stop the trial
The trial team will ask you to fill out a questionnaire before you start treatment, at set times during the trial and when you stop treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment.The tests include
To find out if you are suitable for the trial, the researchers need to make sure your cancer has a change to the MET gene. So they will send a sample of your cancer to the lab. This can be from a stored sample of cancer already collected from you after starting treatment with erlotinib. If there isn’t a sample of your cancer stored, you will need to have a new
On the first day of each 4 week treatment cycle you have another physical examination, heart trace and urine test.
You have blood tests on the first day of each treatment cycle and then a week and 2 weeks later. You have a CT, PET or MRI scan every 6 weeks.
When you stop having the trial treatment you will have some more blood tests, a urine test, a heart trace and a physical examination.
You will meet with the trial doctor to discuss how you are. You then have a scan every 3 months until your cancer starts to grow again.
As LY2875358 is a new drug, there may be some side effects we don’t know about yet. Possible side effects include
- Tiredness (fatigue)
- Loss of appetite and taste changes
- Feeling and being sick
- Collection of fluid around the lungs
- Abnormal blood test results
- Cough and difficulty breathing
- Swollen feet and hands
- Chills and fever when drug is being given
The most common side effects of erlotinib include
How to join a clinical trial
Dr Denis Talbot
Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer