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

Cancer type:

Lung cancer
Small cell lung cancer

Status:

Results

Phase:

Phase 2

This trial looked at ipilimumab and chemotherapy for people with small cell lung cancer that had spread outside the lung.

Cancer Research UK supported this trial.

More about this trial

Small cell lung cancer can sometimes spread to the lymph nodes outside the lung or into other parts of the body. This is extensive stage disease.

The chemotherapy drugs carboplatin and etoposide are often used to treat extensive small cell lung cancer. But the cancer can start to grow again. When this happens it is more difficult to treat.

In this trial researchers looked at a drug called ipilimumab as well as chemotherapy.

Ipilimumab is a type of biological therapy called a monoclonal antibody. It targets cancer cells by looking for a particular protein on the surface called CTLA-4. Ipilimumab stops CTLA-4 from switching off part of the immune system. So it may help the immune system to destroy cancer cells.

The main aims of the trial were 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

Summary of results

The trial team concluded that ipilimumab together with chemotherapy can help some people with extensive small cell lung cancer.  

39 people from the UK took part in this phase 2 trial. This was the first chemotherapy treatment people had.  

Everyone had up to 6 treatment cycles of carboplatin and etoposide. Each treatment cycle lasted 3 weeks. People had:

  • carboplatin and etoposide on the 1st day of each treatment cycle (day 1)
  • etoposide on day 2 and 3 of each cycle

People also had ipilimumab. They had it on day 1 of cycles 3, 4, 5 and 6 (together with carboplatin and etoposide).

After they finished chemotherapy, people continued to have ipilimumab every 12 weeks. This was for as long as the cancer stayed the same and the side effects weren’t too bad.

The team were able to look at the results of:

  • the side effects (39 people)
  • how well the treatment worked (38 people)

The trial team looked at the average length of time people lived without any signs of their cancer getting worse. This is called progression free survival. They found it was almost 7 months.

They also looked at the amount of time people lived. This is called overall survival. They found it was 17 months.

The team compared this with the average amount of time people with extensive small cell lung cancer live. On average people live for almost 10 months.   

The trial team looked at the side effects people had. The most common side effects were:

  • problems such as muscle weakness, headaches and feeling agitated (neurological side effects)
  • diarrhoea
  • rash

5 people died either during treatment or not long after treatment finished. This was due to the side effects of ipilimumab.

The trial team looked at how many people were alive after 1, 2 and 3 years of treatment. They found that:

  • almost 6 out of every 10 people (58%) were alive after 1 year
  • almost 3 out of every 10 people (29%) were alive after 2 years
  • 1 out of every 10 people (10%) were alive after 3 years

People had extra blood tests as part of this trial. The trial team looked for certain proteins (antibodies), to see if they were related to how the treatment worked.

They found that some people had antibodies produced by their immune system, called autoantibodies. These people lived longer without any signs of their cancer getting worse.

Some people had a type of auto antibody called anti neuronal antibodies. People with these antibodies had worse neurological side effects.

The trial team concluded that ipilimumab together with chemotherapy helped a small number of people with small cell lung cancer. But there were a lot of serious side effects.

They think future studies should use a lower dose of ipilimumab. They also suggest that ipilimumab should be given after chemotherapy instead of together. This should reduce the amount of side effects people have but should still mean they get the benefit from the treatment.

The researchers also concluded that more studies are needed to confirm if certain antibodies are related to how the treatment works and its side effects.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

6209

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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