“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of LY2181308 alongside chemotherapy for non small cell lung cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing LY218308 and docetaxel together with docetaxel alone for non small cell lung cancer that has spread into the surrounding tissue, or to other parts of the body. It is for people who have already had one other type of chemotherapy (
Doctors often use chemotherapy to treat non small cell lung cancer that has spread outside the lung. If the cancer gets worse after this first line treatment, you may have more chemotherapy. Docetaxel is one of the drugs that doctors may use. This trial is trying to find out if a new drug called LY2181308 can help docetaxel to work better.
Many types of cancer cells contain large amounts of a protein called survivin, which can make cancer cells more resistant to docetaxel. LY2181308 may reduce the amount of survivin. Researchers hope that reducing the amount of survivin will make more cancer cells die when you have docetaxel.
The aims of this trial are to
- See if docetaxel and LY2181308 together works better than docetaxel alone for advanced non small cell lung cancer
- Learn more about the side effects
Who can enter
You can enter this trial if
- You have non small cell lung cancer that is stage 3B or 4
- Your doctors don’t think another treatment will cure your cancer
- You have already had 1 other type of chemotherapy and your cancer has got worse since this treatment
- You are well enough to take part (the first 15 people joining the study will need to have a performance status of 0 or 1, people joining the trial later may be able to have a performance status of 0, 1 or 2 – the trial doctor will advise you about this)
- There is a sample of tissue available from when you had a
biopsyto diagnose your lung cancer
- You have satisfactory blood test results
- You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have cancer that has spread to your brain or spinal cord
- Have had radiotherapy to your chest in the last month
- Have had radiotherapy to any other part of your body in the last 2 weeks, or have not recovered from the side effects of earlier treatment (you can take part if you have had radiotherapy for symptoms more recently)
- Have had radiotherapy to more than a quarter of your
- Have already taken part in any trials of LY2181308
- Have had another experimental drug as part of a clinical trial in the last month (this could be less than a month if there is no chance that any of the drug is still in your body, you have recovered from any side effects and it would not affect you taking part in this trial)
- Are known to be sensitive to docetaxel, other
taxanedrugs or other drugs similar to LY2181308
- Have another serious medical condition, including (but not limited to) unstable angina, a blood clot in the lung, high blood pressure that cannot be controlled with medication or other lung disease
- Have had another cancer apart from non melanoma skin cancer or carcinoma in situ of the cervix that have been successfully treated, prostate cancer with a Gleason score no higher than 6, or any other cancer if you have been free of disease for at least 3 years
- Already have nerve damage caused by cancer treatment (peripheral neuropathy) unless it is very mild
- Are pregnant or breastfeeding
This is a phase 2 trial. It will recruit about 150 people, including 30 in the UK. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you, nor your doctor can decide which group you are in. There will be twice as many people in group 1 as in group 2.
The trial starts with a ‘lead in’ phase. During this part of the study, people in group 1 have LY2181308 through a drip into a vein (an infusion) on 3 days in a row. It takes 3 hours each time. People in group 2 have infusions in the same way, but the drip contains just salt water (saline). A few days after the lead in phase, you start 3 week cycles of treatment.
People in group 1 then have LY2181308 through a drip into a vein once a week, on days 1, 8 and 15 of each 3 week treatment cycle. This takes about 3 hours each time. On day 1 of each cycle they also have docetaxel through a drip which takes about another hour.
People in group 2 just have docetaxel through a drip on day 1 of each treatment cycle.
Everybody will take dexamethasone tablets twice a day for 3 days each time they have docetaxel. As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you.
The researchers will take blood samples during the trial and get a sample of tissue taken when your cancer was first diagnosed. They will also ask you to have an extra
They will use these samples to look for biomarkers. These are substances in the body that doctors can measure to help them see how a disease is developing, or how a treatment is working.
They will also use the samples to study how your genes affect the way you respond to treatment. This is called
The researchers will take some extra blood samples to learn more about what happens to the drugs in the body. This is called
The trial team will ask you to fill out a questionnaire before you start treatment, at the beginning of each treatment cycle and when you finish treatment. The questionnaire will ask about any side effects you have had and how you have been feeling. This is called a quality of life study.
You will see the trial doctors and have some tests before you start treatment. The tests include
- Physical examination
- Heart trace (
- CT scan
- Blood and urine tests
You go to hospital 3 days in a row during the lead in phase of the trial. Then you go to hospital once a week throughout the rest of the trial treatment. You have regular blood tests and a CT scan every 6 weeks.
When you finish treatment, you go back to see the doctors about a month later. And you have another scan. After that, you see the trial team every 2 months for a year. You may need to have more scans during this time.
As LY2181308 is a new drug, there may be some side effects we don’t know about yet. Known side effects include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- High temperature (fever) or sweating
- Feeling or being sick
- Tiredness (fatigue)
- Changes to the way your liver works
- Loss of appetite and changes to your sense of taste
There is more about the side effects of docetaxel on CancerHelp UK.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Denis Talbot
Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer