A trial looking at lenvatinib for people with neuroendocrine tumours that have spread (TALENT)

Cancer type:

Neuroendocrine tumour (NET)

Status:

Results

Phase:

Phase 2

This trial was for people with a neuroendocrine tumour that had started in the pancreas, stomach or bowel.

This trial was open for people to join between October 2016 and September 2017. 

More about this trial

Neuroendocrine tumours (NETs) are rare tumours. They start in specialist cells of the neuroendocrine system. There are neuroendocrine cells in most organs of the body. They help to control how our bodies work. The type of NET you have, depends on the type of cells affected.
 
The treatment for NET is often surgery. But sometimes the cancer can spread to other parts of body. This is metastatic cancer. 
 
Doctors wanted new ways to help these people. In this trial, they looked at a drug called lenvatinib.
 
Lenvatinib is a targeted cancer drug. It works by blocking certain proteins that help cells to grow blood vessels. All cancer cells need blood vessels to survive and grow. Doctors thought lenvatinib could stop the tumour growing.
 
This trial had 2 groups. People in one group had a NET that started in the pancreas. People in the other group had a NET that started in the stomach or bowel.
 
The main aims of this trial were to:
  • find out how well lenvatinib worked
  • learn more about the side effects
  • look for substances (biomarkers) that could help tell how well treatment worked
     

Summary of results

The team found that lenvatinib worked well for people with neuroendocrine tumours that started in the pancreas, stomach or bowel that had spread. 

About this trial
This was a phase 2 trial. 111 people took part:

  • 55 people had a NET that started in the pancreas (cohort A)
  • 56 people had a NET that started in the stomach or bowel (cohort B)

Everyone had already had treatment. This included one or more of the following or a combination of:

Everyone had a scan of where their tumour had spread:

  • before starting treatment 
  • during treatment
  • when they finished treatment

Researchers compared these scans to see how well lenvatinib worked. 

Results
Of the 111 people the team had results for 106 people. They found that for:

  • 31 people (29.2%) their tumour had shrunk (a partial response)
  • 70 people (66%) their tumour had stayed the same (stable disease)
  • 2 people (2%) their tumour had got worse (progressive disease)

Of the 55 people with a NET that started in the pancreas researchers had the results for 52 people. When they looked at how well lenvatinib worked for these people they found that for:

  • 21 people (40.4%) their tumour had shrunk
  • 29 people (55.8%) their tumour had stayed the same
  • 2 people (3.8%) their tumour had got worse

Of the 56 people with a NET that started in the stomach or bowel researchers had the results of 54 people. They found that for:

  • 10 people (18.5%) their tumour had shrunk
  • 41 people (76%) their tumour had stayed the same

3 people (2.8%) from this group didn’t have scans. So the team weren’t able to assess how well their treatment worked. 

The team also looked at the average time people lived without their tumour getting worse. They found it was:

  • just over 14 months (14.2) for people whose NET started in the pancreas
  • just over 17½ months (17.6) for people whose NET started in the stomach or bowel


Side effects
The team found that the side effects were the same as reported in other trials with lenvatinib. These included:

  • feeling or being sick
  • weakness and tiredness (fatigue)
  • high blood pressure
  • diarrhoea
  • loss of appetite
  • headache

Samples
Researchers are still looking at the samples they collected. When results for these are available this summary will be updated. 

Conclusion
The trial team concluded that lenvatinib worked well for people with a NET that had started in the pancreas, stomach or bowel that had spread. 

Lenvatinib showed promise in stopping NETs coming back for people who had already had treatment.   

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) but may not have been published in a medical journal.  The figures we quote above were provided by the research team. 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 Juan Valle

Supported by

Grupo Español de Tumores Neuroendrocrinos (GETNE)
The Christie NHS Foundation Trust

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14978

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

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"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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