A trial of a vaccine called AST-VAC2 for non small cell lung cancer

Cancer type:

Lung cancer
Non small cell lung cancer
Secondary cancers

Status:

Open

Phase:

Phase 1
This trial is looking at making immune cells to help your immune system to recognise and attack lung cancer cells. 
 
It is a vaccine for people in 1 of the following situations:
  • you have cancer that has grown into nearby tissue or it has spread elsewhere in the body
  • you have completed treatment for lung cancer and don’t need any more at the moment
Cancer Research UK supports this trial. 

More about this trial

Doctors are always looking for ways to improve treatment for non small cell lung cancer. In this trial, they are looking at AST-VAC2.
 
AST-VAC2 is a new type of cancer vaccine. Researchers make the vaccine from dendritic cells using human embryo cells. The embryos were donated for medical research. Dendritic cells are a type of white blood cell Open a glossary item. They are an important part of the immune system Open a glossary item. They help it to recognise cancer cells and destroy them. 
 
Researchers hope that the vaccine will stimulate the immune system to recognise cancer cells and attack them. We call this having an immune response Open a glossary item.
 
The trial is in 2 parts. Part 1 is looking at how safe treatment is. Part 1 is open. Part 2 is testing the vaccine in more people. Part 2 isn't open yet. Some people in the trial will have the vaccine and some people won’t. But you only have the vaccine if you test positive for certain proteins in a blood test. This is the first time people are having the vaccine.
 
The main aims of the trial are to:
  • find out how safe treatment is
  • find out if the vaccine stimulates the immune cells
  • learn more about the side effects

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. 

Who can take part

You may be able to join part 1 of the trial if the following apply
You:
  • have non small cell lung cancer that has spread elsewhere in the body and there isn’t a suitable standard treatment available
  • have cancer that the doctor can measure on a scan
  • have cancer that it might be possible to take tissue samples from
  • haven’t had chemotherapy in the last 4 weeks, an experimental treatment in the last 6 weeks or immunotherapy Open a glossary item in the last 8 weeks
You may be able to join the 2nd part of the trial if the following applies:
  • you have non small cell lung cancer and you have had surgery and chemotherapy and need no further treatment at this time
For both parts, all the following must apply.
You:
  • have large amounts of certain type of HLA protein Open a glossary item if you are having the vaccine
  • are well enough to have 6 vaccinations
  • 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 willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance that you or your partner could become pregnant
Who can’t take part
You cannot join the trial if the following apply.
 
Cancer related 
You:
  • have had radiotherapy unless it was for symptom control Open a glossary item such as pain in the 4 weeks before starting treatment
  • have side effects from past treatments unless they are mild apart from hair loss
  • are having steroids unless it is replacement treatment, a cream or an inhaler or another treatment that dampens down your immune system
Medical conditions
You:
  • haven’t fully recovered from major surgery to your chest or tummy (abdomen)
  • have an active infection that needs treatment
  • have an autoimmune condition Open a glossary item 
  • have congestive heart failure, an abnormal rhythm of the heart, narrowed arteries in the heart or any other significant heart problem
  • are having an experimental treatment as part of another clinical trial
  • have a condition that might interfere with how your immune system works
  • have hepatitis B or hepatitis C
  • have HIV
  • have any other medical condition that the trial team think could affect you taking part 
Other
You:
  • have had a live vaccine within 4 weeks of having AST-VAC2

Trial design

This trial is taking place in the UK. It is a phase 1 trial. It is in 2 parts. Part 1 is for people whose treatment has stopped working and there is no other standard treatment available. Part 1 is open. Part 2 is for people who have recently completed their treatment and don’t need further treatment at that time. Part 2 is not open yet. 
 
The researchers hope to find 24 people to join each part of the trial. So, in total, 48 people will take part. 
 
Not everyone has the vaccine. This is because it only works if there are specific proteins on your cancer cells. You have a blood test to check if you have these proteins or not. When the results are available, you are put into 1 of the following groups. You:
  • have the vaccine if you test positive for a specific HLA protein
  • don’t have the vaccine if you test negative for this protein (this is the observation group)

 

 

Those having the vaccine have it once a week for 6 weeks. You have 2 injections just under the skin each time. These might be into your arm, thigh, abdomen or buttock. 

Research samples 
The trial team will ask to take some extra blood samples and samples of skin if you are having the vaccine. You don’t give the samples if you are in the observation group.

You give the blood samples at the same time as your routine blood tests if possible. The trial team will give you more information about the specific timings of these tests. 

They will also ask to take a sample of skin (a skin biopsy Open a glossary item). Your doctor will have a look at the area where you had the injections to see if you have had a reaction (or an inflammatory response). The doctor will ask to take a skin biopsy if the area is red inflamed or swollen. They plan to take up to 3 skin biopsies.

The researchers plan to use the samples to understand how AST-VAC2 works. 

Hospital visits

You see a doctor and have some tests before you join the trial. These include:
  • physical examination
  • blood tests
  • urine tests
  • heart trace (ECG Open a glossary item)
  • CT scan or MRI scan
You go to hospital once a week for your injections. You see the doctor at each visit for a check up and some blood tests. 
 
You go to hospital 2 to 3 days after one of your vaccinations to check the injection sites. 
 
You see the trial team a month after your final vaccination. They will repeat most of the tests they did at the beginning of the trial.
 
The trial team will follow up at your routine hospital appointment to see how you are getting on. They do this for up to 2 years. They will continue to follow you up for a further 3 years. They will check your medical notes to see how you are doing.
 
Observation group
You won’t have any extra hospital visits if you join this trial. The trial team will check your medical notes to see how you are getting on. You have your routine check ups with your doctor as usual. 

Side effects

As AST-VAC2 is a new drug, there may be side effects we don’t know about. The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything. 
 
The possible side effects include:
  • a reaction at the injection site such as redness or swelling
  • an allergic reaction
  • tiredness (fatigue)
  • muscle aches
  • low temperature
  • an overreaction of the immune system causing high temperatures, chills and a fast pulse
  • abnormal cell growth resulting in a lump under the skin
The trial doctor will explain all the possible side effects before you join the trial. 

Location

Birmingham
Southampton

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof Christian Ottensmeier

Supported by

Cancer Research UK

Other information

This is Cancer Research UK trial number CRUKD/17/003.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15137

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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