A trial looking at lenvatinib for advanced kidney cancer

Cancer type:

Kidney cancer
Renal cell cancer




Phase 2

This trial looked at a biological therapy drug called lenvatinib for kidney cancer that had spread to another part of the body. It was for people whose first treatment had stopped working.

More about this trial

Kidney cancer that has spread is called advanced or metastatic kidney cancer. Having a biological therapy Open a glossary item that blocks blood vessel growth to cancer cells is the usual first treatment. This might include sunitinib or pazopanib.

If this stops working, you might have another type of biological therapy called everolimus. This is called second line treatment.

Researchers wanted to improve second line treatment for advanced kidney cancer. In this trial, they looked at lenvatinib. It is a biological therapy that blocks blood vessel growth.

Researchers thought it might be a useful treatment on its own or alongside everolimus. But they wanted to find out more.

The aims of the trial were to: 

  • find out if lenvatinib is a useful treatment 
  • learn more about the side effects.

Summary of results

The trial team found that having lenvatinib alone or with everolimus worked better than having everolimus alone.

153 people took part. They were put into 1 of 3 groups at random.

  • 52 had lenvatinib
  • 51 had everolimus and lenvatinib
  • 50 had everolimus

The researchers 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, this was 

  • just over 7 months in the people who had lenvatinib
  • just over 14 months in the people who had everolimus and lenvatinib
  • about 5 1/2  months in the people who had everolimus

Diagram for trial results

People who had everolimus alone had the fewest serious side effects. The most common was a drop in red blood cells (anaemia). 

People who had lenvatinib alone or with everolimus had more problems with 

  • diarrhoea 
  • high blood pressure

The lenvatinib group also had more problems with protein in the urine. And the lenvatinib group had problems with tiredness (fatigue) and weakness. 

The trial team concluded that having lenvatinib alone or with everolimus improved progression free survival. 

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

Dr James Larkin

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer’ 

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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.”

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