Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at ipilimumab for advanced non small cell lung cancer (IDEATE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at ipilimumab, carboplatin and paclitaxel for non small cell lung cancer (NSCLC) that has spread to another part of the body or come back after treatment (advanced NSCLC).
Ipilimumab is a type of biological therapy called a monoclonal antibody. It works by stimulating the body’s
The aims of this trial are to find out
- If the combination of ipilimumab, carboplatin and paclitaxel is better than the combination of carboplatin and paclitaxel
- How safe this combination is
- More about the side effects
Who can enter
You may be able to enter this trial if you
- Have a type of non small cell lung cancer called squamous cell
- Have lung cancer, that has spread to another part of the body (stage 4), is causing fluid to collect around your lungs or has come back after treatment
- Have at least 1 area of cancer that hasn’t been treated with radiotherapy and can be measured on a scan
- Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are willing to use reliable contraception during treatment and for at least 3 months afterwards if you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if
- Your cancer has spread to your brain
- You have a significant collection of fluid around your lungs (
pleural effusion) that keeps coming back after treatment
- You have had
systemic treatmentfor lung cancer that had spread – if it was chemotherapy intended to cure your cancer and was more than a year ago, you may still be able to join
- You have a disease where your body mistakenly identifies something that is natural to it as foreign (autoimmune disease), for example ulcerative colitis, Crohn’s disease, rheumatoid arthritis or systemic lupus erythematosus, and you have had medication to suppress your immune system (such as steroids) for more than 2 months
- You have moderate to severe nerve damage (
- You have had another cancer in the past 5 years apart from successfully treated cancers, such as non melanoma skin cancer, superficial bladder cancer or
carcinoma in situof the cervix or breast
- You are HIV, hepatitis B or hepatitis C positive – the researchers will test for these after you agree to take part in this trial
- You have any other medical condition that could affect you taking part in this trial
- You are pregnant or breastfeeding
This is an international phase 3 trial. It will recruit 920 people from different countries around the world. This 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. And neither of you will know which group you are in either. This is called a double blind trial.
People in group 1 have ipilimumab, carboplatin and paclitaxel. People in group 2 have a dummy drug (placebo), carboplatin and paclitaxel.
You have all these drugs through a drip into a vein. You start by having carboplatin and paclitaxel once every 3 weeks. Each 3 week period is called a cycle of treatment. You have these drugs for 2 cycles. On the 3rd cycle you start having ipilimumab or placebo with the carboplatin and paclitaxel. You have 4 cycles of treatment with all 3 drugs.
After this you can continue to have ipilimumab or placebo once every 3 months as long as your cancer isn’t getting worse and the side effects aren’t too bad.
The trial team will ask you to fill out a questionnaire before you start treatment, during treatment and after your treatment has finished. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you take part in this trial the researchers will ask your permission to take extra blood samples. They will use these samples to find out more about non small cell lung cancer and how ipilimumab works in the body. You don’t have to agree to these if you don’t want to. You can still take part in the main trial.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor regularly for a physical examination, blood tests, urine test and a MRI scan or CT scan.
After treatment you see the doctor every 3 months for the same tests.
The most common side effects of the combination of ipilimumab, carboplatin and paclitaxel are
- Hair loss
- Joint pain
- Feeling or being sick (nausea)
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Muscle weakness
- Tingling in the hands and feet
Your doctor will talk to you about the side effects before you agree to take part in the trial.
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.
Professor Christian Ottensmeier
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)