A trial of durvalumab and domvanalimab for non small cell lung cancer (PACIFIC-8)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 3

This trial is looking at durvalumab and domvanalimab for non small cell lung cancer that has grown into surrounding tissues.  

It is for people with non small cell lung cancer that:

  • is locally advanced Open a glossary item
  • can’t be removed by surgery and
  • hasn’t got worse following chemoradiotherapy Open a glossary item

More about this trial

Chemoradiotherapy is a usual treatment for non small cell lung cancer. It is a combination of chemotherapy and radiotherapy. You might have durvalumab after this to strengthen the effect of the chemoradiotherapy.

Durvalumab is an immunotherapy. It works by stimulating the immune system Open a glossary item to find and kill cancer cells. This can slow down or stop the growth of the cancer. 

Domvanalimab is a new drug and is another type of immunotherapy. It targets cancer cells in a slightly different way to durvalumab. 

We know from early research that adding domvanalimab to durvalumab might work better than durvalumab on its own. So doctors are running this trial to find out more. 

In this trial some people have durvalumab and domvanalimab. And some have durvalumab and a dummy drug (placebo Open a glossary item).

The main aims of the trial are to find out:

  • if durvalumab and domvanalimab work better together than durvalumab on its own
  • more about the side effects
  • how treatment affects quality of life Open a glossary item

Who can enter

The following bullet points are a summary of 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 this trial if all of the following apply. You:

  • have non small cell lung cancer (NSCLC)
  • have stage 3 non small cell lung cancer that has spread into surrounding tissues and you can’t have surgery to remove it
  • have had chemoradiotherapy for stage 3 non small cell lung cancer
  • have cancer that didn’t get worse after chemoradiotherapy and the chemotherapy included a platinum drug Open a glossary item such as cisplatin or carboplatin. You can’t take part if the chemotherapy you had included gemcitabine.
  • have had at least 2 cycles Open a glossary item of chemoradiotherapy that finished in the month before starting the treatment in this trial
  • had the last dose of chemotherapy before or with your last dose of radiotherapy. You can’t take part if you had chemotherapy after radiotherapy.
  • had a PET-CT scan within 3 months of starting chemoradiotherapy
  • have a sample of tissue (biopsy Open a glossary item) available for the trial team to do some tests on
  • have cancer that is PD L1 positive. Your doctor will test for this.
  • have had a total dose of 60GY of radiotherapy. You might be able to take part if you have had a little bit more or less than this dose. Your doctor will know this.
  • are active but might not be able to do heavy physical work (performance status of 0 or 1)
  • have satisfactory blood test results
  • weigh at least 30kg when you are put into a treatment group
  • are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
  • are able to give informed consent Open a glossary item
  • are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

  • have cancer that has spread to the membranes surrounding the brain
  • have a mixture of non small lung cancer cells and small cell lung cancer cells
  • have a change (mutation Open a glossary item) in the ALK or EGFR genes in the lung cancer cells. Your doctor will know this.
  • are having or have had radiotherapy, an experimental treatment, chemotherapy, immunotherapy or targeted drugs Open a glossary item to treat NSCLC
  • have cancer that has grown into major blood vessels such as the main artery around the lungs or heart tissues
  • took part in a trial looking at durvalumab and domvanalimab even if you didn’t have these treatments
  • have locally advanced cancer Open a glossary item that got worse during chemoradiotherapy
  • might have surgery to remove your lung cancer as part of your treatment plan
  • have changes in certain genes in your lung cancer cells. Your doctor will check this.
  • might need any other cancer treatment during the trial
  • have had another cancer in the past unless it has been successfully treated. There must be no signs of it in the last 5 years or it must have a low chance of coming back. You can take part if you had successfully treated non melanoma skin cancer Open a glossary item, lentigo maligna melanoma, carcinoma in situ Open a glossary item or very early bladder cancer 

Medical conditions
You cannot join this trial if any of these apply. You:

  • have high blood pressure that isn’t well controlled with medication
  • have an active bleeding problem
  • have a serious problem with your digestive system Open a glossary item that is causing diarrhoea
  • have had a heart attack in the last 6 months or a significant heart problem Open a glossary item that needs treatment. The trial team check if you have a heart condition before you join the trial.
  • have had an immunotherapy or experimental drug in the 4 weeks before the first dose of trial treatment or a monoclonal antibody drug in the 6 weeks before joining trial treatment. This applies to treatment for a medical condition and not to treatment for NSCLC. 
  • have had a bone marrow or stem cell transplant with somebody else’s cells (allogeneic transplant Open a glossary item) or an organ transplant Open a glossary item in the past
  • have an autoimmune condition Open a glossary item that needs treatment apart from certain ones. Your doctor will know about this.
  • have had a severe infection in the 4 weeks before you start trial treatment
  • have scarring on the lungs or active inflammation of the lungs (pneumonitis Open a glossary item) or moderate to severe pneumonitis caused by radiotherapy
  • have a problem with how your immune system Open a glossary item works
  • have HIV, an active Epstein Barr Virus, an active hepatitis B or hepatitis C infection or any other severe infection that needs treatment
  • are having or have had treatment that dampened down your immune system with 2 weeks of starting trial treatment
  • have had a major surgery within 4 weeks of starting trial treatment
  • are having another cancer treatment
  • have moderate to severe side effects from cancer treatment that aren’t getting better. You can join if you have hair loss or another bad side effect that won’t get worse with trial treatment.
  • are taking part in another clinical trial unless it doesn’t involve a treatment, you had treatment as part of a clinical trial in the last 3 months or you are in follow up
  • have any other medical or mental health problem that the trial team think could affect you taking part

Other
You cannot join this trial if any of these apply. You:

  • are allergic to the drugs in the trial, similar drugs or anything they contain
  • have had a live vaccine Open a glossary item in the 30 days before starting trial treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine.
  • are pregnant or breastfeeding 

Trial design

This is a phase 3 trial. The trial team need about 860 people to have the treatment in this trial. This includes 28 people from the UK. 

It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will either of you know which group you are in. 

There are 2 treatment groups. You have 1 of the following:

  • durvalumab and domvanalimab
  • durvalumab and a dummy drug (placebo Open a glossary item)

You have durvalumab, domvanalimab or the dummy drug as a drip into a vein. You have treatment once a month. You have durvalumab first followed by domvanalimab or the dummy drug. 

You have treatment once every 4 weeks for up to 1 year for as long as it is working and the side effects aren’t too bad. 

You stop treatment if your cancer gets worse. The trial team will talk to you about other treatment options. 

Blood and tissue samples for research 
The researchers ask you to give an extra tissue sample. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to use the samples to:

  • see how well treatment is working
  • look at genes Open a glossary item to understand more about non small cell lung cancer
  • see what happens to durvalumab and domvanalimab in the body 
  • look for substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others

You need to agree to give most of the samples to take part in the trial. There are a few samples you can say no to. The team can let you know more about this.   

Quality of life
The trial team ask you to fill out some questionnaires:

  • before you start treatment
  • at set times during and after treatment 

The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor and have tests before you can take part. These include:

You have your treatment at the hospital on the day care ward. You shouldn’t’ need to stay overnight. 

You go to the hospital every 2 weeks in the first month of treatment for a check up and blood tests. After that you have a check up once a month.

You have a CT or MRI scan every:

  • 8 weeks for the first year 
  • every 3 months until year 5 and then
  • every 6 months until year 6

You have the trial scans until your cancer gets worse. You also have one more scan at least a month later if your cancer does get worse. 

When you finish treatment, you see the trial team for a check up once a month for 4 months. The team then contact you every 2 months to see how you are getting on. They will check if you have started another cancer treatment.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

Durvalumab and domvanalimab can affect the immune system Open a glossary item. This may cause inflammation Open a glossary item and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects. 

These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.
 
If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

 

Domvanalimab is a new drug. Only a few hundred people have had it so there may be some side effects we don’t know about yet.

The most common side effects of domvanalimab include:

We have information about durvalumab and its side effects.

Durvalumab and domvanalimab is a new combination of treatment. So there may be some side effects we don’t know about yet.

Location

Birmingham
Brighton
Cardiff
Cheltenham
Leeds
London
Newcastle upon Tyne
Nottingham

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

Dr Shobhit Baijal

Supported by

AstraZeneca

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18641

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

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think