A trial looking at giving darbepoetin alfa to people with 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 3

This is a trial looking at giving darbepoetin alfa to people with non small cell lung cancer who are having chemotherapy.

Doctors often treat non small cell lung cancer with chemotherapy. One of the side effects of chemotherapy is a drop in red blood cells. Red blood cells carry oxygen around the body. If your red blood cells are low you can feel tired and breathless. Doctors call this anaemia.

Doctors can treat this by giving you a blood transfusion through a drip into a vein. They can also treat it by giving you a red blood cell growth factor (erythropoietin). These red blood cell growth factors help your body make more of its own red blood cells. Darbepoetin alfa is red blood cell growth factor.

The aims of this trial are to find out

How safe it is to give darbepoetin alfa
Can darbepoetin alfa help people with non small cell lung cancer
If darbepoetin alfa can lessen the need for blood transfusions

Who can enter

You can enter this trial if

You have non small cell lung cancer in both lungs or that has spread to other parts of your body or has caused a fluid collection around your lungs or heart that contains cancer cells (stage 4)
You are having chemotherapy for the first time (first line treatment) to treat your cancer, and are to have at least 2 more cycles of treatment after agreeing to take part in the trial
You are having chemotherapy and your full blood count test shows your haemoglobin count is 11 or less
Your other blood test results are satisfactory
You are fully active and able to carry out your normal daily activities (performance status 0, 1)
You are 18 years or older

You cannot enter this trial if you

Have had treatment for your non small cell lung cancer before
Are known to have other medical conditions that can cause low numbers of red blood cells (anaemia) - your doctor can advise you about this
Have had treatment with erythropoietin (EPO) to increase your red blood cell count in the last 28 days
Have had EPO treatment before that has failed
Are not able to have EPO treatment
Have had a blood transfusion within 4 weeks of starting treatment with darbepoetin alfa
Have had any other cancer, unless it has been successfully treated and there has been no sign of it returning for at least 3 years (if you have had non melanoma skin cancer that has been removed completely with surgery or carcinoma in situ of the cervix that has been treated successfully within 3 years you can still enter this trial)
Have cancer that has spread to your brain
Have high blood pressure that cannot be controlled with medication
Have heart problems that cannot be controlled with medication
Have had a heart attack in the last 6 months
Have taken medication to stop fits in the last 30 days
Are known to be HIV positive
Are known to have hepatitis B or hepatitis C
Have problems with blood clots, like deep vein thrombosis (DTV), in the last 6 months
Have another medical condition that could affect you taking part in this trial

Trial design

This is an international phase 3 trial. It will recruit about 3,000 people from different countries around the world. It is a randomised trial. The people taking part are put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in or be told which group you are in. This is common in clinical trials and is called a double blind trial.

Group 1 in this trial will have darbepoetin alfa. Group 2 will have a dummy treatment (placebo). Of those entering the trial, 2 out of every 3 will be in group 1, and so have darbepoetin alfa.

You have darbepoetin alfa, or placebo, after each 3 week cycle of chemotherapy. You have darbepoetin alfa, or placebo, as an injection under the skin (subcutaneous injection).

If you take part in this trial, the researchers will ask your permission to take samples of tissue from when you had a biopsy Open a glossary item . These samples will be stored safely and may be used in the future, but for research purposes only.

Hospital visits

You will see the doctor and have a number of tests before taking part in this trial. These tests include

Physical examination
Blood tests
Scan

You will see the doctor every 3 weeks to have a physical examination and blood test. And you will have a scan every 9 weeks, until your cancer begins to grow again.

You will then see the doctor every 3 months.