
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a type of biological therapy called a vaccine for non small cell lung cancer that cannot be removed with surgery.
If non small cell lung cancer (NSCLC) has spread out of the lung into surrounding tissue, or to another part of your body (stage 3B or stage 4), it is not possible to remove it with surgery. But you may have chemotherapy. This is a .
Growth factors are natural body chemicals that control cell growth. They work by plugging in to receptors which send signals telling the cells to divide and grow. Non small cell lung cancer cells often have a large number of receptors for a growth factor called EGF.
In this trial, researchers are looking at a vaccine that targets EGF and stops it attaching to the cancer cell receptors. They hope that giving the vaccine alongside chemotherapy will help people with advanced NSCLC to live longer.
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 3 trial will recruit about 438 people with advanced non small cell lung cancer. 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 taking part have the EGF vaccine and chemotherapy. The other half have chemotherapy alone.
If you are in the group having chemotherapy alone, you start chemotherapy shortly after joining the trial.
If you are in the vaccine group, you start by having a single low dose of a chemotherapy drug called cyclophosphamide through a drip into a vein. You have this to improve your body’s response to the EGF vaccine.
A few days later, you start the vaccine treatment. You have 2 doses of the vaccine, 2 weeks apart. These are injections into a muscle. You start chemotherapy about a week after the 2nd dose of the vaccine.
You then have more doses of the vaccine a couple of days before both your 2nd and 3rd cycles of chemotherapy.
After you finish chemotherapy, you can carry on having the vaccine alone every 4 or 8 weeks until your cancer starts to get worse.
Each time you have the vaccine before and during chemotherapy, you have 4 separate injections into different muscles. So you have an injection in each of your arms and each of your legs.
After you finish chemotherapy, you have only 1 injection each time you have the vaccine.
The trial team will ask everybody taking part to fill out a questionnaire before they start treatment, a number of times during treatment and at follow up appointments after they finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
The trial team will ask your permission to get a sample of tissue that was removed if you had a to diagnose your cancer. They will use this to look for changes in your genes. This is optional and you don’t have to agree to give this sample if you don’t want to. You can still take part in the trial. The researchers will not ask you to have a new biopsy at this time.
During chemotherapy, you go to hospital at least every 3 weeks and have a CT or MRI scan every 6 weeks. People in the vaccine group have about 4 extra hospital visits.
After you finish chemotherapy, you see the trial team every 4 to 8 weeks and have a scan every 8 weeks until your cancer starts to get worse. If you are in the vaccine group, you have a dose of the vaccine at each of these visits.
As the EGF vaccine is a new treatment, there may be side effects we don’t know about yet. In other trials, the most common side effects have included
We have information about the side effects of cyclophosphamide in our cancer drugs section. But the dose of cyclophosphamide used in this trial is very low.
We have more information about the side effects of lung cancer chemotherapy in our lung cancer section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Marianne Nicolson
Bioven
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”