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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at the drugs erlotinib and bevacizumab for non small cell lung cancer that has spread and has changes to genes affecting a protein called EGFR Open a glossary item.

If non small cell lung cancer has spread outside the lung (advanced lung cancer), doctors often treat it with chemotherapy. But if your cancer cells have specific gene changes (mutations Open a glossary item) that affect a protein called EGFR, you may have treatment with a type of biological therapy called a tyrosine kinase inhibitor (TKI). Erlotinib (also known as Tarceva) is a TKI that doctors can use to treat non small cell lung cancer that has spread.

In this trial, researchers are looking at having erlotinib with another drug called bevacizumab (also known as Avastin). Bevacizumab is a monoclonal antibody. It works by targeting a protein on cancer cells called VEGF.

The aims of the trial are to

  • See how well erlotinib and bevacizumab works for advanced non small cell lung cancer with an EGFR gene change
  • Learn more about the side effects of this drug combination

Who can enter

You may be able to enter this trial if you

  • Have non small cell lung cancer that has spread outside your lung
  • Have cancer that has the EGFR gene change – the trial team will get a sample of your cancer from when you were diagnosed to check for this
  • Can’t have surgery, radiotherapy or chemoradiation with the aim of curing your cancer
  • Have cancer that doctors can see and measure on a scan
  • Have satisfactory blood test results
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Are able to swallow tablets
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial and for at least a year afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have cancer that has spread to your brain and this is causing symptoms or needs treatment
  • Have cancer that has spread into the bones of your spine causing spinal cord compression
  • Have cancer that is growing into (or very close to) a major blood vessel
  • Have had chemotherapy for lung cancer that has spread – you may be able to take part if you had chemotherapy before or after surgery to try to stop your cancer coming back as long as this finished at least 6 months ago
  • Have already had drugs that target EGFR or VEGF to treat your lung cancer
  • Have had major surgery or a significant injury in the last 4 weeks, or minor surgery in the last week
  • Have had another experimental drug in the last 3 weeks
  • Have a medical condition that puts you at an increased risk of bleeding, or you have coughed up more than half a teaspoonful of fresh blood in the last 3 months
  • Have taken drugs to thin your blood (anti coagulants) in the last 10 days, unless this was a low dose of aspirin or heparin
  • Take other medication that can affect a body protein called CYP3A4
  • Have high blood pressure that can’t be controlled with medication, or have had serious problems with high blood pressure in the past - the trial team can advise you about this
  • Have had a heart attack, stroke or blood clot in the last 6 months
  • Have heart pain (angina) or certain other heart problems – the trial team can advise you about this
  • Have a problem with your digestive system Open a glossary item that could affect how you absorb tablets
  • Have a peptic ulcer Open a glossary item that can’t be controlled with medication, or a wound in your digestive system that has caused an abnormal opening (a fistula Open a glossary item)
  • Have epileptic fits (seizures)
  • Have certain eye conditions – the trial team can advise you about this
  • Have had any other cancer in the last 5 years apart from non melanoma skin cancer or very early stage cancer (carcinoma in situ Open a glossary item) of the bladder, cervix Open a glossary item or breast that has been successfully treated
  • Have certain mental health problems including dementia or any other medical problem that the trial team think could affect you taking part
  • Are known to be very sensitive to bevacizumab, erlotinib or anything the drugs contain
  • Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit about 100 people in different countries. Everybody taking part has erlotinib and bevacizumab.

You have bevacizumab through a drip into a vein every 3 weeks. Erlotinib is a tablet that you take each day. The trial team will ask you to keep a diary at home to record when you take each dose.

As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it helps you.

Hospital visits

You see the trial team and have some tests before you start the trial treatment. The tests include

  • Physical examination
  • Blood tests and urine tests
  • CT scan

To find out if your cancer has the EGFR gene change, the trial team will get a sample of your cancer that was removed when you were diagnosed with lung cancer.

During treatment, you go to hospital once every 3 weeks. You have regular blood tests and urine tests. You have a CT scan every 6 weeks for the first 18 weeks, every 9 weeks for the next 6 months and then every 12 weeks after that, until your cancer starts to get worse.

When you finish treatment you see the trial team again. You have a physical examination and blood tests. If you stop the treatment because of bad side effects, you may need to have another CT scan if you haven’t had one in the last month.

If you stop the treatment but your cancer has not grown, the trial team will ask you to carry on having regular CT scans until your cancer does start to get worse.

Side effects

The most common side effects of bevacizumab include

The most common side effects of erlotinib include

We have more information about bevacizumab and erlotinib in our cancer drugs section. The trial team will talk to you about all the possible side effects before you agree to join the trial.

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:

Oracle 10664

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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