A trial of pembrolizumab for non small cell lung cancer (KEYNOTE-001)

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Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Results

Phase:

Phase 1

This trial was for people with NSCLC that had spread into the tissues surrounding the lungs, or to another part of the body (advanced cancer).

More about this trial

Chemotherapy is a treatment for advanced NSCLC. But researchers are looking for new ways to help people with advanced NSCLC. In this trial, they looked at a drug called pembrolizumab (Keytruda or MK3475).

Pembrolizumab is a type of targeted cancer drug called a monoclonal antibody. It works by helping the immune system Open a glossary item cells to attack the cancer.

The main aims of this trial were to:

  • learn more about the side effects of pembrolizumab and what happens to the drug in the body
  • find out how well pembrolizumab works for people with advanced NSCLC

Summary of results

The trial team concluded that pembrolizumab helps people with advanced NSCLC.

This was a phase 1 trial. 495 people with advanced NSCLC took part. Some people were having treatment for the 1st time. And others had already had treatment for NSCLC.

Everyone had treatment with pembrolizumab for as long as it helped them, and the side effects weren’t too bad. People had pembrolizumab either every 2 weeks or every 3 weeks.

The trial team looked at how well pembrolizumab worked. To do this they looked at the average length of time people lived without any signs of their cancer getting worse. Doctors call this progression free survival.

They found that on average people lived almost 4 months without any signs of their cancer getting worse. People who were having treatment for the 1st time lived longer than people who had already had treatment for lung cancer.

The research team also looked at the average length time people lived. This is called overall survival. They found that on average, people lived for around 12 months.

The team looked at the most common side effects people had. They were:

  • tiredness (fatigue)
  • skin rash and itchy skin
  • feeling sick and decreased appetite
  • diarrhoea
  • joint pain

Doctors asked everyone who took part to give a sample of tissue. They wanted to look for a protein called programmed death ligand 1 (PD-L1) on the surface of cancer cells. Doctors found that pembrolizumab worked better for people who had the PD-L1 protein in at least half (50%) of their cancer cells.

The trial team concluded that pembrolizumab helps people with advanced NSCLC. They think this is a safe treatment. They also concluded that the protein PD-L1 can help to tell who benefits most from this treatment.

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 Gary Middleton

Supported by

Merck, Sharp & Dohme

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Last review date

CRUK internal database number:

11477

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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