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 , such as cisplatin or carboplatin, for advanced non small cell lung cancer
You are willing to have a small piece of tissue (biopsy ) 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 , 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 – 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 )
Heart scan (ECHO or MUGA )

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

Temporary changes to your eyesight
Diarrhoea
Feeling or being sick
Tiredness
Loss of appetite
A drop in red blood cells causing shortness of breath
Drop in substances in your blood called electrolytes
Muscle pain
Changes to the rhythm of your heart

The most common side effects of pemetrexed are

A drop in blood cells causing an increased risk of infection, bruising and bleeding
Feeling or being sick
Loss of appetite
Skin rash
Diarrhoea
Sore mouth
Hair thinning

The most common side effects of docetaxel are