A trial looking at AUY922 for advanced non small cell lung cancer

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 a new drug called AUY922 for non small cell lung cancer (NSCLC) that has spread from where it started in the lung or has come back after treatment (advanced lung cancer). It is for people whose lung cancer cells have high levels of a protein called epidermal growth factor receptor (EGFR positive Open a glossary item).

Doctors often treat this type of lung cancer with a biological therapy such as erlotinib or gefitinib. But these drugs can stop working and the cancer can start to grow again. This means the cancer has become resistant to these treatments. Researchers are looking for new treatments to help people in this situation. In this trial, they are looking at a new drug called AUY922.

AUY922 is a biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. We know from laboratory studies Open a glossary item that AUY922 can stop cancer cells with high levels of epidermal growth factor receptor (EGFR positive) from growing.

In this trial, researchers will compare AUY922 with the chemotherapy drugs pemetrexed and docetaxel. The aims of the trial are to find out

  • How well AUY922 works for people with lung cancer that is resistant to erlotinib and gefitinib
  • More about the side effects

Who can enter

You may be able to enter this trial if

  • You have non small cell lung cancer (NSCLC) that has spread to the lymph glands on the other side of your chest or to the other lung (stage 3B) or to another part of your body (stage 4) or has come back after treatment
  • Your lung cancer cells have epidermal growth factor receptors (EGFR) – your doctor can confirm this
  • Your lung cancer initially responded to treatment with erlotinib or gefitinib and then started to grow again
  • You have already had a chemotherapy drug from a group called platinum drugs Open a glossary item, such as cisplatin or carboplatin, for advanced non small cell lung cancer
  • You are willing to have a small piece of tissue (biopsy Open a glossary item) taken from your cancer
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have an area of cancer that can be measured on a scan
  • You have satisfactory blood tests results
  • You are willing to use reliable contraception during treatment and for a month afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter this trial if

  • You have had more than 2 courses of treatment with chemotherapy for advanced non small cell lung cancer – you may be able to take part if the chemotherapy was in addition to surgery or radiotherapy and was more than 6 months ago
  • Your cancer is causing pressure on your spinal cord (spinal cord compression)
  • Your cancer has spread to your spine or brain – you may be able to take part if the cancer spread was treated with radiotherapy or gamma knife Open a glossary item, you have been stable for 2 months and aren’t taking steroids
  • You have had erlotinib or gefitinib in the past 10 days
  • You have had a platinum chemotherapy drug in the past month
  • You have had radiotherapy in the past month apart from radiotherapy for symptom control
  • You still have side effects from any treatment apart from hair loss or hair thinning
  • You have had treatment with a HSP90 inhibitor – your doctor can confirm this
  • You have problems with your kidneys or liver
  • You have had major surgery in the past 2 weeks
  • You are been treated for an infection
  • You have moderate to severe diarrhoea
  • You have had a heart attack in the past 6 months or any other serious heart problem
  • You have had any other cancer in the last 5 years, unless it was a very early stage and has been successfully treated – the trial team can advise you about this
  • You have moderate to severe breathlessness
  • You are taking steroids apart from inhalers or a short course to stop you feeling sick
  • You are HIV positive
  • You are allergic to the drugs used in this trial, or their ingredients
  • You have a problem with the way your body breaks down bilirubin Open a glossary item – your doctor can confirm this
  • You are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. It will recruit 120 people from different countries around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Half the people will have AUY922 through a drip into a vein every week.

The other half will have either pemetrexed or docetaxel chemotherapy through a drip into a vein every 3 weeks. Your doctor will decide which one you have.

trial diagram

You can continue having treatment as long as it is helping you and the side effects aren’t too bad.

The researchers will get a sample of tissue removed when your cancer was diagnosed. If a sample of tissue is not available, they will ask you to have another biopsy before you start the trial treatment. They will use these tissue samples, along with blood samples to look for biomarkers. Biomarkers are substances in the body that doctors can measure to see how a disease is developing or how a treatment is working.

If you are in the group having AUY922, the trial team will take a number of blood samples to look at what happens to the drug in the body. This is called pharmacokinetics Open a glossary item.

Hospital visits

You will see the doctor to have some tests before you start treatment. The tests include

  • Physical examination
  • Eye test
  • Blood and urine tests
  • CT scan or MRI scan
  • Heart trace (ECG Open a glossary item)
  • Heart scan (ECHO Open a glossary item or MUGA Open a glossary item)

During treatment people having AUY922 go to hospital once a week, but there will be extra hospital visits in the first 6 weeks of treatment. During these visits, you have a number of blood tests and ECGs.

People who are having pemetrexed or docetaxel go to the hospital every 3 weeks.

Everybody taking part has a CT or MRI scan every 6 weeks.

At the end of treatment everyone sees the doctor to have the same tests they had at the beginning of the trial.

After treatment you see the doctor every 3 months. If you stopped treatment for any reason other than your cancer was getting worse you will have a CT scan or MRI scan every 3 months until you start another treatment.

Side effects

AUY922 is a new drug and there may be side effects we don’t know about yet. The most common side effects reported include

The most common side effects of pemetrexed are

The most common side effects of docetaxel are

Your doctor will talk to you about the possible side effects before you agree to take part in the trial.

We have more information about pemetrexed and docetaxel in our cancer drugs section.

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 Samreen Ahmed

Supported by

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

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9861

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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