A trial looking at a vaccine for people with advanced 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 (NSCLC)

Status:

Closed

Phase:

Phase 3

This trial is looking at an epidermal growth factor (EGF) vaccine for people with non small cell lung cancer that has spread to other parts of the body.

More about this trial

Non-small cell lung cancer (NSCLC) can sometimes spread from where it started in the lungs. This is called advanced NSCLC (or stage 4 NSCLC).

If NSCLC spreads to other parts of the body, you might not be able to have surgery to remove it. But you can have treatment with chemotherapy. Usually a combination of chemotherapy drugs is used.

Drugs commonly used include:

cisplatin (or carboplatin)
docetaxel
gemcitabine
paclitaxel
pemetrexed (or vinorelbine)

EGF stands for epidermal growth factor. It is a protein that sends signals to cells, telling them when to grow and divide. People with non small cell lung cancer (NSCLC) often have high levels of EGF.

In this trial, doctors are looking at an EGF vaccine. They think it can attach to the EGF and stop the cancer cells from dividing.

In this trial people have 1 of the following:

EGF vaccine with chemotherapy
chemotherapy

The main aims of this trial are to:

find out how well EGF vaccine works as a treatment
learn about the side effects
find out what happens to EGF vaccine in your body
find out about other growth factors that may affect NSCLC

Who can enter

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 have NSCLC that has spread to other parts of the body
Your NSCLC does not have a change in the EGFR protein (it’s a wild type EGFR) – your doctor will check for this
You have a large amount of EGF in your blood – the doctor will check for this
You have satisfactory blood tests
You have at least 1 area of cancer that can be seen on a scan and measures at least 10 mm
You are well enough to have chemotherapy
You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are at least 18 years old
You are willing to use reliable contraception during treatment and for 90 days after your last vaccine if there is any possibility you or your partner could become pregnant. If you are a man, you must be willing to use male condoms to avoid the possibility of passing on the EGF vaccine

You cannot join this trial if any of these apply.

Cancer related

Your NSCLC has a change in the EGF receptors (EGFR mutation)
Your NSCLC has spread (or your doctor thinks it may have spread) to your brain or the spinal cord (the central nervous system)
Your doctor thinks you can have radiotherapy to your thorax together with chemotherapy (or radiotherapy after chemotherapy)
You take drugs that stimulate your immune system to fight the cancer (immunotherapy)
You have had another cancer that was successfully treated with chemotherapy or radiotherapy more than 5 years ago (or less than 5 years if it was a carcinoma in situ of the cervix or non melanoma skin cancer). You may be able to take part if you have had radiotherapy to help with pain from cancer that has spread to the bones (palliative radiotherapy)

Medical conditions

You have an autoimmune disease such as rheumatoid arthritis
You have had an operation to remove your spleen (splenectomy)
You have an active infection
You have heart problems such as congestive heart failure, a heart attack in the past 12 months, high blood pressure that is not controlled by medication, angina that is not controlled or an irregular heart beat (arrhythmia) that needs medication
You have moderate or severe problems with your neurological system, or problems with your liver, kidneys or any other metabolic disease (such as diabetes) that are not well controlled
You have loose poo (diarrhoea) that you would describe as fairly or very bad (moderate or severe)
You have taken drugs to damp down your immune system such as corticosteroids, azathioprine or cyclosporine in the past 4 weeks (unless it is a cream or an inhaler)
You have HIV
You have hepatitis B or hepatitis C
You have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Other

You are currently taking part in another clinical trial of an experimental drug or device or it has been less than 1 month since you completed a clinical trial
You are known to be allergic to the drugs in this study or anything they contain
You have had a vaccine in the past 4 weeks (apart from the flu vaccine)
You have taken drugs or drank an amount of alcohol that is a concern for your doctors in the past 6 months
You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need about 418 people to take part worldwide. And hope that between 36 to 40 people from the UK will take part.

This trial is randomised. The people taking part are put into 1 of the following groups by a computer:

EGF vaccine with chemotherapy
chemotherapy

Neither you nor your doctor will be able to decide which group you are.

Diagram-showing-trial-randomisation

EGF vaccine with chemotherapy
You have a chemotherapy drug called cyclophosphamide as a drip into a vein. This helps the vaccine to work better.

After 1 to 3 days, you come back to hospital to have the EGF vaccine. You have it as an injection into your muscle. You need to stay in hospital for 3 hours after the injection to check if you have any side effects. You should not need to stay overnight.

After 2 weeks you have another EGF vaccine.

Within 7 to 10 days, you start chemotherapy. You have it in cycles of treatment. Your doctor can tell you more about what drugs you have.

You have more EGF vaccines during the time you have chemotherapy. You have them:

2 days before the 2nd cycle of treatment
2 days before the 3rd cycle of treatment

You continue to have chemotherapy for as long the treatment is helping you and the side effects aren’t too bad. You can have up to 6 treatment cycles.

After you finish chemotherapy, you may continue to have the EGF vaccine if it’s still helping you. You have it:

9 weeks after finishing chemotherapy
then every 8 weeks

You continue to have the vaccine for as long your cancer stays the same and the side effects aren’t too bad.

You might also continue to have chemotherapy with a drug called pemetrexed. Your doctor can tell you more about this.

Chemotherapy
You have your chemotherapy as a drip into a vein. Your doctor can tell you more about the drugs you will have.

You continue to have chemotherapy for as long as it is helping you and the side effects aren’t too bad. You can have up to 6 treatment cycles.

If your cancer stays the same, you may continue to have chemotherapy with pemetrexed.

Quality of life
Everybody taking part on this trial will be asked to complete a set of 2 quality of life questionnaires:

before starting treatment
at set times during treatment

They take about 25 minutes to complete each time. The questionnaires ask about how you have been feeling and what side affects you have had.

Blood tests
You have some extra blood tests if you have the EGF vaccine. The research team wants check for the amount of EGF and EGF antibodies in your blood.

You have the extra blood tests:

before each EGF vaccination
before each treatment cycle of chemotherapy
after finishing your treatment

Tissue samples
The doctors need a tissue sample (a biopsy) of your cancer before you start treatment. This is to check for:

changes in the EGF receptors
changes in the KRAS and ALK gene

The trial doctors will ask to use a tissue sample of your cancer taken either when you were diagnosed or during other treatments. If there is not a suitable sample available, the researchers may ask you to have a biopsy.

You don’t have to agree to have an extra tissue sample if you don’t want to. You can still take part in this trial.

Diary card
If you have the EGF vaccine, the trial team will ask you to keep a diary card. This is to record any reactions you might have at the place where you had the injections. You complete this record for 5 days after each vaccination.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

a physical examination
a urine test
blood tests
heart trace (ECG)
a CT scan or MRI scan

You see the doctor for blood tests and a physical examination before each treatment cycle. If you are in the EGF vaccine group you see the doctor before you have your injections.

You have a CT or MRI scan on alternate treatment cycles (so during cycle 2, 4 and 6).

If you have EGF vaccines and you continue them after you finish your chemotherapy, you see a doctor for blood tests and a physical examination:

after 9 weeks
then every 8 weeks

You also have a CT or MRI scan each time you have a vaccination. This continues as long as your cancer stays the same and does not get worse. If your cancer gets worse, you stop having the EGF vaccine.

If you have pemetrexed, you see the doctor for blood tests and a physical examination every 3 weeks. This will also continue as long as your cancer stays the same. If your cancer gets worse, you stop having pemetrexed.

When you stop treatment, you see the trial team:

30 days after the last treatment
then every 12 weeks

Side effects

The trial team monitor you during the time you have treatment and you will have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

The most common side effects of the EGF vaccine are: