A trial of ipilimumab with chemotherapy for small cell lung cancer (CA184156)

Cancer type:

Lung cancer

Small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial looked at a drug called ipilimumab alongside chemotherapy for people recently diagnosed with small cell lung cancer (SCLC).

Everyone who took part had SCLC that had spread into the lymph nodes Open a glossary item outside the lung or to other body organs. This is extensive stage SCLC.

More about this trial

Extensive stage SCLC is often treated with a combination of chemotherapy drugs. This is because combinations of chemotherapy tend to work better than single drugs. Doctors often combine:

etoposide
cisplatin or carboplatin

In this trial researchers looked at a targeted cancer drug (biological therapy) called ipilimumab (Yervoy). It targets cancer cells by looking for a particular protein called CTLA-4. Ipilimumab stops CTLA-4 from switching off part of the immune system Open a glossary item . So it might help the immune system to destroy cancer cells.

The main aim of this trial was to see if chemotherapy and ipilimumab is better than chemotherapy alone for people who have been recently diagnosed with extensive stage SCLC.

Summary of results

The trial team concluded that chemotherapy and ipilimumab is not better than chemotherapy alone at helping people with recently diagnosed extensive stage SCLC.

This was an international phase 3 trial. 1123 people took part.

It was a randomised trial. Everyone was put into 1 of the following treatment groups by computer:

chemotherapy (etoposide and either cisplatin or carboplatin) and ipilimumab
chemotherapy (etoposide and either cisplatin or carboplatin) and a dummy drug (placebo )

Neither they nor their doctor could choose which group they were in. And neither they nor their doctor knew which treatment they were having. This was a double blind trial.

The research team looked at the number of people that took part in each group:

478 people had chemotherapy and ipilimumab
476 people had chemotherapy and the dummy drug

CA184156 trial diagram

169 people didn’t complete treatment.

The study team looked at how well the treatment worked. To do this they 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 5 months (4.6 months) for people in the chemotherapy and ipilimumab group
just over 4 months (4.4 months) for people in the chemotherapy and dummy drug group

They also looked at the amount of time people lived. This is called overall survival. They found it was around 11 months for both groups.

The trial team looked at the side effects people had. The most common side effects for the chemotherapy and ipilimumab group were:

a drop in blood cells causing an increased risk of infection, tiredness and breathlessness
diarrhoea

The most common side effect for the chemotherapy and dummy drug group was a drop in blood cells causing a risk of infection, tiredness and breathlessness.

People who had chemotherapy and ipilimumab had worse side effects than people who had chemotherapy and the dummy drug.

The trial team concluded that chemotherapy and ipilimumab is not better than chemotherapy alone at treating extensive stage SCLC. And people had worse side effects.

Researchers aren’t too sure why ipilimumab didn’t help people with extensive stage SCLC. One possible reason is that chemotherapy reduces the number of immune cells and this may stop ipilimumab (which stimulates the immune system to kill cancer cells) from working well. There is research going on looking at using ipilimumab with other types of targeted cancer drugs for people with SCLC.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) 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.