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

10664-bar-chart-1.png

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

10664-bar-chart-2.png

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

10664-bar-chart-3.png

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.