"I am glad that taking part in a trial might help others on their own cancer journey.”
A trial of apatorsen and chemotherapy for non small cell lung cancer that has spread (CEDAR)
This trial is looking at gemcitabine and carboplatin chemotherapy with a new drug called apatorsen for people with non small cell lung cancer (NSCLC) that has spread. It is for people with a type of NSCLC called squamous cell lung carcinoma. The trial is supported by CRUK.
Doctors usually treat non small cell lung cancer (NSCLC) that has spread outside the lung (advanced lung cancer) with chemotherapy. The standard chemotherapy drugs they use are called gemcitabine and carboplatin. They help, but doctors are always looking for ways to improve treatment. In this trial they are looking at a drug called apatorsen.
Apatorsen (OGX-427) is a new drug that targets a protein in the body called Hsp27. The Hsp27 protein can help cancer cells to protect themselves from cancer treatment. Hsp27 is only found in some types of lung cancer. The doctors in this trial think that by blocking Hsp27, or removing it from cancer cells, might help gemcitabine and carboplatin chemotherapy to work better.
The aims of this trial are to find out
- If apatorsen helps gemcitabine and carboplation chemotherapy to work better for people with squamous cell lung cancer
- More about the side effects
Who can enter
You may be able to join this trial if all of the following apply. You
- Have squamous cell lung cancer that has come back or spread locally (stage 3B) or to another part of your body (stage 4)
- Can’t have surgery, radiotherapy or
chemoradiationwith the aim of curing your cancer
- Haven’t had any other treatment that reaches your whole body (
systemic treatment) for cancer that has spread. You may take part if you had chemotherapy before or after surgery to remove your cancer, as long as you finished this treatment a year ago and you did not have gemcitabine - you can also enter if you have had immunotherapy (without chemotherapy) to treat your cancer
- Have at least 1 area of cancer that has not been treated with radiotherapy, measures at least 10 mm across (if it is a
lymph gland, 15 mm) OR you may be able to take part if it your cancer has spread to your bones and can’t be measured on a scan (your doctor can tell you more about this)
- Are willing to let the study team to look at the samples of tissue (
biopsy) that were taken when you were first diagnosed (if you do not have any you can still take part in the trial)
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use 2 different types of reliable contraception during the trial and for at least a month afterwards if there is any chance you or your partner could become pregnant
You cannot join this trial if any of these apply.
- Your cancer has spread to your brain or spinal cord unless this has been successfully treated, you have no symptoms, and your condition has been stable for the last month
- You have cancer that has changes to genes affecting proteins called EGFR or ALK and for which there may be another treatment available ( your doctor can tell you more about this)
- You have a significant heart problem
- You have nerve damage from other treatment (peripheral neuropathy) unless it is only mild
- You have had any other cancer in the past, apart from
non melanoma skin cancerthat was successfully treated
- You have had any experimental medicine as part of a clinical trial
- You have any other medical condition or there is any other reason that the study doctor thinks could affect you taking part
- You are pregnant or breast feeding
This is a phase 2 trial. The researchers need 140 people to join the trial. It is a randomised trial.The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in
- Group 1 have gemcitabine and carboplatin
- Group 2 have gemcitabine, carboplatin and apatorsen
To begin with, the people in group 2 have apatorsen on 3 separate occasions over a 9 day period. This is called a loading dose and ensures that you have enough apatorsen in your body when you start the treatment cycles.
You have gemcitabine, carboplatin and apatorsen as injections into a vein. Everyone will have carboplatin once every 3 weeks and gemcitabine twice every 3 weeks. The people in group 2 also have apatorsen once a week. The treatment takes about 2 hours each time.
Each 3 week period is called a cycle of treatment. If the trial treatment is helping you and not causing bad side effects, you may have up to 6 cycles of treatment.
The researchers in this trial may ask for extra blood samples and samples of your cancer (a
The trial team will ask you to fill out a questionnaire before you start treatment and at regular times during the trial. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You will see the doctor and have some tests before you start treatment. The tests include
During treatment, you go to hospital once a week. You have regular blood tests. You have a CT scan every 6 weeks until your cancer starts to get worse.
After you finish treatment you see the trial team again. They will repeat some of the tests you had before you started the trial. The people will group 2 will have blood tests every 3 weeks. Everybody will continue to see the trial doctor every 2 months for up to 2 years.
Apatorsen is a new drug and there may be side effects we don’t know about yet. The most common side effects so far include
- A reaction to the drug causing fever, chills, flushing, feeling or being sick, diarrhoea and tiredness
- A drop in blood cells causing an increased risk of bleeding problems, tiredness and breathlessness
- Kidney problems
- Liver problems
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.
Professor Peter Schmid
Barts Cancer Institute
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Oncogenex Pharmaceuticals Inc
Queen Mary University of London
This is Cancer Research UK number CRUKE/13/014