A trial comparing pembrolizumab with docetaxel for non small cell lung cancer (KEYNOTE-010)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Results

Phase:

Phase 2/3

This trial compared pembrolizumab with docetaxel for advanced non small cell lung cancer (NSCLC). The trial was for people:

  • who had already had treatment for their lung cancer with a platinum chemotherapy drug Open a glossary item
  • whose cancer cells produced a protein called PD-L1
  • whose cancer had grown into surrounding tissues or spread elsewhere in the body (advanced cancer)

More about this trial

The usual treatment for NSCLC is chemotherapy including a platinum drug such as carboplatin or cisplatin. If this doesn’t work, you might have another chemotherapy drug called docetaxel. But researchers were looking for ways to improve treatment.

In this trial, they looked at a drug called pembrolizumab (also known as MK3475). It is a type of targeted cancer drug called an immunotherapy Open a glossary item. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells. This triggers the immune system Open a glossary item to find and kill cancer cells.

In this trial, the researchers compared 2 different doses of pembrolizumab with docetaxel.

The aims of this trial were to:

  • find out how safe pembrolizumab was
  • find out how well it worked compared with docetaxel
  • learn more about the side effects

Summary of results

The trial team found that pembrolizumab increased the length of time people lived after treatment compared with docetaxel. And the side effects were manageable.

1, 034 people took part in this phase 2/3 trial. They were put into 1 of the 3 following treatment groups at random.

  • 345 had the usual dose of pembrolizumab
  • 346 had a higher dose of pembrolizumab 
  • 343 had docetaxel

How long people lived

The researchers looked at the how long people lived after treatment. This is called overall survival. On average this was:

  • 10.4 months in people who had usual dose pembrolizumab
  • 12.7 months in people who had higher dose pembrolizumab
  • 8.5 months in people who had docetaxel

They found pembrolizumab worked better in people who had more than half of their cancer cells positive for PD-L1. In these people, average overall survival was:

  • 14.9 months in people who had usual dose pembrolizumab
  • 17.3 months in people who had higher dose pembrolizumab
  • 8.2 months in people who had docetaxel

The researchers also looked at how long people lived before the cancer started to grow again. This is called progression free survival. But they didn’t find a difference between the 3 treatment groups.

Side effects

People who had docetaxel had more serious side effects than those who had pembrolizumab. The researchers were mainly interested in immune system side effects caused by pembrolizumab. The more serious of these included:

  • inflammation of the walls of the lung (pneumonitis)
  • skin reactions such as rash or itchiness

The trial team concluded that pembrolizumab improved how long people lived after treatment. They say this finding showed it could be a new treatment option for people with advanced NSCLC whose cancer cells are positive for PD L1.

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.

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 Dean Fennell

Supported by

Experimental Cancer Medicine Centre (ECMC)
Merck Sharp & Dohme
NIHR Clinical Research Network: Cancer

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10623

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think