A trial looking at ipilimumab for advanced non small cell lung cancer (IDEATE)

Cancer type:

Lung cancer

Non small cell lung cancer

Secondary cancers

Status:

Results

Phase:

Phase 3

This trial looked at ipilimumab, carboplatin and paclitaxel for non small cell lung cancer (NSCLC).

It was for people who had advanced NSCLC. This means that their cancer had:

spread to another part of the body
come back after treatment

More about this trial

This trial started in 2011 and these results were published in 2017. Researchers wanted to find out whether adding ipilimumab to the chemotherapy drugs carboplatin and paclitaxel worked better than chemotherapy alone. The trial was for people with advanced NSCLC who hadn’t had chemotherapy before.

During the time this trial was done one of the possible treatments for advanced NSCLC was a combination of the following chemotherapy drugs:

carboplatin
paclitaxel

Ipilimumab (Yervoy) is a type of targeted cancer drug called monoclonal antibody. It works by stimulating the body’s immune system Open a glossary item

to fight cancer cells.

Ipilimumab is already a treatment for people with other types of cancer, such as melanoma. But doctors wanted to find out if it can also help people with advanced NSCLC.

Summary of results

The trial team concluded that ipilimumab did not help people with advanced NSCLC.

This was an international phase 3 trial. 956 people who were having treatment for advanced NSCLC for the 1st time took part.

This was a randomised trial. This means that the people taking part were put into 1 of the following treatment groups at random by a computer:

479 people had ipilimumab, carboplatin and paclitaxel
477 people had a dummy drug (placebo), carboplatin and paclitaxel

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

Results

The trial team looked at how well ipilimumab worked. To do this they looked at the length of time people lived after treatment. This is called overall survival. They found that:

people who had ipilimumab, carboplatin and paclitaxel lived around 13 months after treatment
people who had dummy drug, carboplatin and paclitaxel lived around 12 months after treatment

The team also 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 that, on average, people in both groups lived almost 6 months without signs of their cancer getting worse.

Side effects

The trial team looked at the most common side effects people in the ipilimumab group had. They were:

a drop in the number of blood cells causing an increased risk of breathlessness, infection and bleeding
diarrhoea
decreased appetite
skin rash and itching
sickness
tiredness (fatigue)
numbness and tingling in fingers and toes

The most common side effects people in the dummy drug group had were a drop in the number of blood cells, diarrhoea, decreased appetite, sickness, tiredness and numbness in fingers and toes.

Conclusion

The trial team concluded that treatment with ipilimumab, carboplatin and paclitaxel is well tolerated.

They also concluded that ipilimumab together with carboplatin and paclitaxel doesn’t help people with advanced NSCLC. But doctors think that ipilimumab together with other targeted drugs may help people in this situation. They continue to look for different treatment combinations with ipilimumab.

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.