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.

Cancer type:

Lung cancer
Non small cell lung cancer




Phase 3

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).

Doctors usually treat advanced NSCLC with chemotherapy or radiotherapy. They may also use biological therapies.

Ipilimumab is a type of biological therapy called a monoclonal antibody. It works by stimulating the body’s immune system Open a glossary item. The researchers think that combining ipilimumab with chemotherapy may be better than chemotherapy only to treat advanced NSCLC. In this trial they will combine ipilimumab with the chemotherapy drugs carboplatin and paclitaxel.

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 Open a glossary item) that keeps coming back after treatment
  • You have had systemic treatment Open a glossary item for 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 (peripheral neuropathy Open a glossary item)
  • 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 situ Open a glossary item of 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

Trial design

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.

IDEATE trial diagram

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.

Hospital visits

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.

Side effects

The most common side effects of the combination of ipilimumab, carboplatin and paclitaxel are

Your doctor will talk to you about the side effects before you agree to take part in the trial.

We have more information on ipilimumab, carboplatin and paclitaxel in our cancer drugs section.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Christian Ottensmeier

Supported by

Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8647

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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