A trial of pemetrexed or etoposide with cisplatin and radiotherapy for locally advanced non small cell lung cancer (PROCLAIM)

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial compared pemetrexed or etoposide alongside cisplatin and radiotherapy for non small cell lung cancer.

It was open to people with non small cell lung cancer that had grown into surrounding tissues (locally advanced Open a glossary item ) and it could not be removed with an operation.

More about this trial

Radiotherapy and chemotherapy are some of the usual treatments for non small cell lung cancer (NSCLC) if it is not possible to have surgery to remove it.

Doctors didn’t know which combination of chemotherapy drugs worked best in this situation but it usually included a platinum drug Open a glossary item such as cisplatin.

In this trial, they compared having a chemotherapy drug called etoposide with having a chemotherapy drug called pemetrexed. Everyone also had cisplatin and radiotherapy.

The aims of the trial were to:

find out which treatment worked best for locally advanced non small cell lung cancer
learn more about the side effects

Summary of results

The trial team found that having pemetrexed, cisplatin and radiotherapy did not work better than having etoposide, cisplatin and radiotherapy for locally advanced non small cell cancer.

Results of the trial were published in 2016. This explained that the trial was stopped after a review by the committee that monitors the safety and design of the trial (the data monitoring committee Open a glossary item ).

The committee looked at the results after people had finished all their treatment. These results suggested that it was very unlikely this trial would be able to show that having pemetrexed worked better than etoposide. So they decided it was best that no more people should take part.

555 people did take part in the trial. They were put into 1 of 2 groups at random.

272 had etoposide, cisplatin and radiotherapy
283 had pemetrexed, cisplatin and radiotherapy

PROCLAIM results diagram

People in the etoposide group had:

2 cycles of treatment with etoposide and cisplatin alongside radiotherapy
2 further cycles of treatment with chemotherapy that included a platinum drug such as cisplatin or carboplatin

People in the pemetrexed group had:

3 cycles of treatment with pemetrexed and cisplatin alongside radiotherapy
4 further cycles of pemetrexed

The researchers looked at how long people lived for after treatment (overall survival). They found that on average, this was:

25 months in the etoposide group
just under 27 months (26.8 months) in the pemetrexed group

So although the above results show a very small difference in survival, it was not statistically significant. This means the difference between the 2 groups could have happened by chance.

The side effects between the 2 groups were similar. But people who had etoposide had more problems with:

a drop in the number of white blood cells (neutropenia)
a drop in the number of platelets
inflammation of the lung tissue (pneumonitis)

The trial team concluded that having pemetrexed, cisplatin and radiotherapy did not improve overall survival compared with etoposide, cisplatin and radiotherapy.

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.