A trial looking at ganetespib and docetaxel for advanced non small cell lung cancer (GALAXY-2)

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 3

This trial is looking at a new drug called ganetespib (pronounced ga-net-es-pib) alongside docetaxel chemotherapy for non small cell lung cancer that has spread.

If non small cell lung cancer has spread into lymph nodes on the other side of your chest, surrounding tissues, or to another part of your body, it is called advanced non small cell lung cancer. Doctors usually treat advanced non small cell lung cancer with chemotherapy that includes a platinum drug Open a glossary item such as cisplatin or carboplatin.

But sometimes the cancer starts to grow again during or after platinum chemotherapy. If this happens you may have more chemotherapy. Docetaxel is a chemotherapy drug that doctors can use. In this trial, researchers are looking at a new drug called ganetespib alongside docetaxel.

Ganetespib is a type of biological therapy called a heat shock protein 90 inhibitor. It stops signals that cancer cells use to divide and grow. Ganetespib may help to slow or stop the growth of lung cancer.

The aims of this trial are to

See if a combination of ganetespib and docetaxel works better than docetaxel alone for advanced non small cell lung cancer
Learn more about the side effects and the effect on peoples’ quality of life

Who can enter

You may be able to enter this trial if

You were diagnosed with advanced non small cell lung cancer at least 6 months ago and it is mainly a type called adenocarcinoma
Your cancer has spread to lymph nodes on the other side of your chest, into nearby body structures, or to another part of your body (stage 3B or 4)
You have only had 1 type of chemotherapy for advanced lung cancer, it included a platinum drug and your cancer got worse during this treatment or has come back afterwards (there are some exceptions to this that the trial team can advise you about)
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have cancer that can be measured on CT scan or MRI scan
You have satisfactory blood test results
You have recovered from the side effects of any other treatment
You are at least 18 years old
You are willing to use reliable contraception during the trial treatment and for up to 6 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if

You have had a drug called a tyrosine kinase inhibitor (TKI) or an experimental drug for advanced lung cancer
You have had radiotherapy in the last 2 weeks
Tests show that your cancer has particular proteins that specific drugs can target or your cancer hasn’t been tested for these proteins yet
Scans show that your cancer has spread to your brain or spinal cord unless this has been treated with radiotherapy and hasn’t got worse for at least 2 weeks after finishing the treatment
You have had any other cancer in the last 5 years, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
You have lost at least 10% of your body weight in the last 4 weeks
You have been coughing up blood
You have numbness or tingling in your hands and feet (peripheral neuropathy) unless this is only mild
You have only 1 area of cancer that can be measured and this has been treated with radiotherapy (if a scan shows that it has since grown by at least 1cm you may be able to take part)
You have certain heart problems, or take medication that can affect your heart rhythm (your doctor will discuss these with you)
You have any other medical condition or mental illness that could affect your taking part or make it unsafe for you to do so
You are pregnant or breastfeeding

Trial design

This international phase 3 trial will recruit about 850 people. It is randomised trial. The people taking part are put into treatment groups by computer. Neither you nor your doctor can decide which group you are in.

One group have docetaxel through a drip into a vein once every 3 weeks.

The other group have docetaxel through a drip into a vein once every 3 weeks. And they also have ganetespib through a drip into a vein twice in every 3 weeks. They have it on the same day they have docetaxel and 2 weeks later.

GALAXY-2 trial diagram

As long as you don’t have bad side effects, you can carry on having treatment for as long as your doctor agrees it is helping you.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Vital signs and blood tests
Heart trace (ECG )
CT scan or MRI scan
Bone scan or PET scan

The trial team will get a sample of your tissue taken when you had surgery or a biopsy Open a glossary item in the past. If there isn’t a sample available, you will need to have a biopsy.

You go to hospital 2 to 4 times in each 3 week cycle of treatment. You have regular blood tests throughout the treatment and more heart traces. You have a CT scan or MRI scan every 6 weeks.

The trial team will ask you to fill out a questionnaire before you start treatment, 6 weeks later, 12 weeks later and at the end of treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

When you stop the trial treatment, a member of the research team will contact you by phone every 6 weeks to see how you are.

If you stop the treatment for any reason other than your cancer getting worse, the researchers will ask you to have a CT or MRI scan every 6 weeks until your cancer does start to get worse, or you start another type of treatment.

Side effects

As ganetespib is a new drug, there may be side effects we don’t know about yet. In the other trials, the most common side effects were

Diarrhoea
A drop in blood cells causing an increased risk of infection, tiredness, high temperature (fever) and breathlessness
Tiredness (fatigue)
Weakness
Feeling or being sick
Loss of appetite
Breathing difficulties
Hair loss
Rash
High temperature (fever)
Cough
Problems sleeping
Constipation