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:

Results

Phase:

Phase 1
This trial looked at helping the immune system recognise and attack lung cancer cells. It was for people who had lung cancer that had grown into nearby tissue or had spread to another part of the body.
 
The trial was supported by Cancer Research UK. It was open for people to join between 2018 and 2022. The team analysed the results in 2023.
 

More about this trial

This trial looked at AST-VAC2 for advanced non small cell lung cancer (NSCLC). AST-VAC2 is a type of immunotherapy called a cancer vaccine

Researchers make the vaccine by using human stem cells. Stem cells are cells that can develop into many different types of cell. 

First, the researchers develop the stem cells into a type of white blood cell called dendritic cells in a laboratory. These cells are an important part of the immune system. Then they modify the dendritic cells to help the immune system recognise lung cancer cells.
 
Researchers hoped the vaccine would stimulate the immune system to recognise and attack lung cancer cells. 
 
The main aims of the trial were to find out:

  • what the side effects are
  • if the vaccine can stimulate immune cells
  • how well the vaccine works as a treatment for lung cancer

Summary of results

The trial showed that AST-VAC2 doesn’t cause too many side effects. It also showed that it can affect the immune system in some people.

Trial design
This was a phase 1 trial. It was for people with advanced non small cell lung cancer (NSCLC). There were no suitable standard treatments Open a glossary item they could have.

A total of 9 people joined this trial to begin with. They were aged between 53 and 62 years old. Two men and 7 women joined the trial.

One person died before they could start treatment. The other 8 people had AST-VAC2 injections once a week for 6 weeks. The injections were given just under the skin.

Results

Side effects
Everyone taking part had at least one side effect. They were nearly all mild or moderate. No one had to delay or stop treatment because of side effects they were having.

Non serious side effects
The most common non serious side effects were:

  • 8 people (100%) had a reaction where they had the injection such as redness, swelling or itching (injection site reaction)
  • 3 people (37%) had extreme tiredness (fatigue)
  • 2 people (25%) had muscle aches and pains

One person had a moderate allergic reaction to the vaccine. The same person had mild psoriasis, a skin reaction. These symptoms improved without needing treatment and the person was able to continue on the trial.

Serious side effects
Researchers can class a side effect as serious for a number of reasons, including if:

  • the person has to go to hospital because of it
  • it is particularly important for the specific treatment in the trial

No one taking part had any side effects that were classed as serious.

How well treatment worked
The trial team looked at how well the vaccine was working when people finished treatment. They found no one’s cancer had gone away or got smaller.

The cancer had:

  • stayed the same for 5 people
  • continued to grow for 3 people

They also looked at how many people were living 2 years after joining the trial. They found it was 3 out of 8 people (37%). This is a bit higher than you might expect with no treatment. But it’s hard to say for sure because of the small number of people in the trial.

Immune response
The trial team looked at how people’s immune system reacted to the vaccine. This is called an immune response Open a glossary item. They tested for an immune response at various times during the trial.

They found that:

  • 2 people had an immune response at more than one time point (researchers call this a durable response)
  • 2 people had an immune response at a single time point
  • 4 people didn’t have an immune response

Conclusion
The research team concluded that the dose of AST-VAC2 used in this trial didn’t cause too many side effects. And that 2 people had an immune response in more than one test. All the results from the trial will be useful for future research.

Other trials of AST-VAC2 in the future may show different results.

Future plans
When this summary was written there were no ongoing trials with AST-VAC2, but further trials were being considered. 

Where this information comes from    
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.

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

Professor Christian Ottensmeier
Professor Gary Middleton 

Supported by

Cancer Research UK - regulatory@cancer.org.uk (trial sponsor Open a glossary item)

The research team would like to thank all the patients who took part in this trial. Doing this helps researchers learn more about cancer and how to treat it.

Other information

The CRUK trial number is CRUKD/17/003.

There is more information about this trial on the clinicaltrials.gov website (NCT03371485):

https://clinicaltrials.gov/ct2/show/NCT03371485

If you have questions about the trial please contact our cancer 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

A picture of Wendy

"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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