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

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 1^st 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.