A trial looking at ipilimumab and chemotherapy for small cell lung cancer (ICE)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer
Small cell lung cancer




Phase 2

This trial is looking into treating small cell lung cancer with a new drug called ipilimumab as well as with chemotherapy. This trial is supported by Cancer Research UK.

Doctors usually use chemotherapy to treat small cell lung cancer that has spread beyond the lungs (extensive disease). They often use the chemotherapy drugs carboplatin and etoposide. Sadly the cancer can start to grow again after chemotherapy. When this happens it is more difficult to treat.

In this trial researchers are looking at giving a drug called ipilimumab as well as chemotherapy.

Ipilimumab is type of biological therapy called a monoclonal antibody. Monoclonal antibodies target cancer cells by looking for particular proteins on the cells’ surface. Ipilimumab targets a protein called CTLA-4. Ipilimumab stops CTLA-4 from shutting down part of the immune system. So it may help the immune system to destroy cancer cells.

The aims of the trial are to

  • Find out if having ipilimumab as well as chemotherapy helps to delay or stop small cell lung cancer coming back
  • Learn more about the side effects
  • Find out more about how ipilimumab affects the immune system

Who can enter

You may be able to enter this trial if you

  • Have extensive stage small cell lung cancer
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have not had any chemotherapy, or have just finished the 1st or 2nd cycle of carboplatin and etoposide chemotherapy
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during the study and for 6 months afterwards if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have cancer that has spread to your brain or central nervous system Open a glossary item, is causing symptoms and needs treating
  • Have an autoimmune disease Open a glossary item such as rheumatoid arthritis or Crohn’s disease - your doctor will discuss this with you
  • Have any medical condition that the trial team think would affect you taking part in this trial
  • Have had a live vaccine Open a glossary item in the last 4 weeks
  • Have had any immunotherapy Open a glossary item in the past, including ipilimumab
  • Take a high dose of steroids Open a glossary item - it is important that you don’t stop taking steroids without talking to your doctor
  • Have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or superficial bladder cancer that was successfully treated at least 5 years ago
  • Are known to be HIV, Hepatitis B or Hepatitis C positive
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit about 40 people. Everybody taking part has chemotherapy and ipilimumab.

You have treatment through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. You have the treatment as an outpatient Open a glossary item.

The chemotherapy is a combination of the drugs carboplatin and etoposide, which you have via a drip into a vein on day 1 of each treatment cycle. On days 2 and 3 of each cycle you take etoposide tablets at home.

You have 6 cycles of chemotherapy. In cycles 3, 4, 5 and 6 you will also have ipilimumab. You have ipilimumab through a drip into a vein.

You will be asked to fill out a questionnaire

  • Before you start treatment
  • On the first day of each cycle of treatment
  • When you finish treatment
  • 6,12, 18 and 24 months after starting the study

The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

18 weeks after starting treatment doctors want to collect some of your white blood cells Open a glossary item for research. They want to look at how your immune system Open a glossary item has been affected by the treatment. These cells are collected during a procedure called leucapheresis Open a glossary item. You have a drip in each of your arms that is attached to a machine. Your blood passes out of one drip, through the machine and back into your body through the other drip. The machine filters the white cells out of your blood. This will take about 3 hours.

You do not have to agree to give these cells if you don’t want to. You can still take part in the study.

If the treatment is helping you after 6 cycles of treatment, you may continue to have ipilimumab every 3 months until your cancer starts to grow again. This is called maintenance treatment.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests may include

  • Physical examination
  • Blood tests
  • Urine test
  • Heart trace (ECG Open a glossary item)
  • Chest X-Ray
  • CT scan

On day 1 of each treatment cycle you will have

  • Physical examination
  • Blood tests
  • Urine test
  • Chest X-Ray

You will also see the doctors on the 8th day of cycles 1, 2 and 6 for blood and urine tests and a chest X-ray.

After 18 weeks, if you have agreed to have leukapheresis, then you go to hospital for up to 3 hours to have your white cells collected.

You will have CT scans and blood tests every 6 weeks for a year, and then every 3 months until your cancer starts to grow again.

If you continue to have ipilimumab 3 monthly after your 6 cycles of treatment, you will see the doctors every month to discuss any side effects you may be having.

Side effects

The most common side effects of the combination of carboplatin and etoposide are

The side effects of ipilimumab are

There is more information about carboplatin, etoposide and ipilimumab on CancerHelp UK.

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
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
University of Southampton Clinical Trials Unit

Other information

This is Cancer Research UK trial number CRUKE/10/019.

We have more information about the work of Prof Christian Ottensmeier.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 6209

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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