A trial of erlotinib and bevacizumab for advanced non small cell lung cancer (BELIEF)

Cancer type:

Lung cancer
Non small cell lung cancer
Secondary cancers

Status:

Results

Phase:

Phase 2

This trial looked at the drugs erlotinib and bevacizumab for non small cell lung cancer (NSCLC).

It was for people with NSCLC  that had spread and had changes to genes affecting a protein called EGFR Open a glossary item.

More about this trial

Doctors often treat non small cell lung cancer that has spread outside the lung (advanced lung cancer) with chemotherapy.

Some cancer cells have specific gene changes (mutations Open a glossary item) that affect a protein called EGFR. In this case doctors treat advanced NSCLC with a targeted drug called erlotinib (Tarceva).

In this trial, researchers looked at combining erlotinib with another drug called bevacizumab (Avastin).

Bevacizumab is another targeted drug that works in a different way to erlotinib. It stops the cancer forming new blood vessels that would supply the cancer with oxygen and food.  

The researchers looked at how these 2 treatments worked in people with cancers that have a particular change in the protein EGFR. This is called T790M.

The aims of the trial were to:

  • see how well erlotinib and bevacizumab worked for advanced NSCLC with an EGFR gene change
  • learn about the side effects

Summary of results

The trial team found that erlotinib and bevacizumab benefited people whose advanced non small cell lung cancer (NSCLC) has a change in the EGFR.

The team looked at the tissue samples of everyone and put them into 2 groups. They were

  • those who had a change in the T790M
  • those who didn’t have this change

This was a phase 2 trial. Everyone had erlotinib and bevacizumab.

Of 109 people who took part:

  • 37 people had the T790M change
  • 72 people didn’t have the change

The team looked at the results in the following way:

  • the total 109 people who took part (overall results)
  • those who had the T790M change
  • those who didn’t have the T790M change

Response to treatment
The team looked at the number of people whose cancer had responded to treatment.

Complete response
This is the number of people who had no sign of their cancer:

  • overall it was 6 people
  • for those who had the T790M change it was 3 people
  • for those who didn’t have the T790M change it was 3 people

Partial response
This is the number of people whose cancer had shrunk:

  • overall it was 78 people
  • for those who had the T790M change it was 24 people
  • for those who didn’t have the T790M change it was 54 people

Stable disease
This is the number of people whose cancer had stayed the same:

  • overall it was 17 people
  • for those who had the T790M change it was 8 people
  • for those who didn’t have the T790M change it was 9 people

For 4 people they couldn’t assess their response to treatment. This was because their cancer was only measured once. So an actual assessment of whether the cancer had changed couldn’t be made.

Progression free survival
This is the average length of time after treatment that their cancer had not got worse.

The team found that:

  • overall it was just over 13 months
  • for those who had the T790M change it was 16 months
  • for those who didn’t have the T790M change it was 10 ½ months

Side effects
The most common side effects included:

  • high blood pressure
  • diarrhoea
  • rash
  • protein in the urine
  • tiredness (fatigue)
  • cough

Conclusion
The trial team concluded the BELIEF trial provides further proof that erlotinib combined with bevacizumab works for people with NSCLC that has an EFGR change.

Other trials are ongoing looking at targeted drugs with bevacizumab for advanced NSCLC that has EGFR and the T790M change.

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 Sanjay Popat

Supported by

European Thoracic Oncology Platform (ETOP)
Roche

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10664

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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