
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people who have already had treatment for their advanced non small cell lung cancer.
Advanced non small cell lung cancer (NSCLC) means that it has spread to another part of the body (metastatic) or into the surrounding tissue (locally advanced).
Chemotherapy is the usual treatment for advanced non small cell lung cancer (NSCLC). 2 chemotherapy drugs often used are paclitaxel and carboplatin. Doctors are always looking for ways they can improve treatment.
Nab-paclitaxel is a type of paclitaxel. It has a protein called albumin attached to it.
CC-486 is a tablet form of the chemotherapy drug azacitidine.
Durvalumab (MEDI4736) is a biological therapy called a monoclonal antibody. It works by targeting a particular protein on the cancer cell. This helps your immune system fight the cancer.
Researchers think giving CC-486 or durvalumab with nab-paclitaxel might benefit people more than nab-paclitaxel only. In this trial they want to compare:
The aims of this trial are to find
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply. You:
You cannot join this trial if any of these apply. You:
Cancer related
Medical conditions
Other
This is an international phase 2 trial. The researchers need 240 people to join.
This is a randomised trial. You are put into 1 of 3 treatments groups by a computer. Neither you nor your doctor can choose which group you are in.
You have nab-paclitaxel as an injection into a vein. You have it once a week for 2 weeks and then you have 1 week with no treatment.
CC-486 is a tablet you take every day for 2 weeks and then you have 1 week with no treatment.
You have durvalumab as an injection into a vein once every 3 weeks.
Each 3 week period is called a cycle of treatment.
You continue to have treatment until your cancer starts to get worse.
Quality of life
The researchers will ask you to fill out questionnaire:
The questionnaires will ask you about how are feeling and any side effects. This is a quality of life study.
Tissue and blood samples
The researchers will ask for a sample of your cancer that was removed when you had surgery or a and for some extra blood samples.
They will use these samples to look for substances (biomarkers) that might tell how well the treatment is working and to see how your genes might affect the way you respond to treatment (pharmacogenetics).
You see the doctor to have some tests before taking part. These tests include
During treatment you see the doctor at the start of each cycle of treatment for a physical examination and blood tests. You have a chest CT scan every 6 weeks.
At the end of treatment you see the doctor for the same tests you had at the start apart from the heart trace. A month later you see the doctor to see how you are and then they will tell you how often they want to see you.
A member of the trial team will phone you every 3 months to find out how you are.
The most common side effects of CC-486 are:
The most common side effects of durvalumab are:
The most common side effects of nab-paclitaxel are:
Your doctor will talk to you about the side effects of the drugs before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor D Talbot
Experimental Cancer Medicine Centre (ECMC)
Celgene
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.