A trial looking at durvalumab for non small cell lung cancer (PACIFIC-4)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 3
This trial is for people with non small cell lung cancer (NSCLC) who:
  • can’t have surgery to remove the lung cancer, or have chosen not to have an operation 
  • are going to have stereotactic ablative radiotherapy (SABR) instead of surgery for lung cancer
It is for people who have an early stage (stage 1 or stage 2) NSCLC. 

More about this trial

Surgery is a common treatment for early stage NSCLC. But sometimes, you can’t have surgery, or you choose not to have an operation. If this is the case, you might have a type of radiotherapy called stereotactic ablative radiotherapy (SABR).
 
SABR gives a high dose of radiation to the cancer from many different angles around the body. This means that the tumour receives a high dose of radiation and the tissues around it receive a much lower dose. 
 
Durvalumab is a type of targeted drug called a monoclonal antibody. It seeks out cancer cells by looking for the PD-L1 protein and attaching to it. The immune system Open a glossary item then recognises the marked cells and kills them. 
 
Everyone taking part in this trial has SABR and then one of the following treatments:
  • durvalumab 
  • dummy drug (placebo)
The main aim of this trial is to find out how well durvalumab works for people with early stage 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. 
 
Who can take part
You may be able to join this trial if all of the following apply:
  • you have stage 1 or stage 2 NSCLC 
  • your doctor thinks that you can’t have surgery to remove the cancer, or you have decided to have SABR instead of lung cancer surgery
  • you are going to have between 3 and 5 treatments (fractions) of SABR  
  • you have a suitable sample of cancer available that is less than 6 months old that was taken during a biopsy  Open a glossary itemor fine needle aspiration Open a glossary item
  • you have satisfactory blood tests results 
  • you have had a PET-CT scan in the last 2 months 
  • you weigh more than 30kg (4 stone 10lb)
  • you are up and about more than half the day, can look after yourself but can’t work (performance status of 0, 1 or 2)
  • you are at least 18 years old
  • are willing to use reliable contraception during treatment and for up to 3 months afterwards if there is any possibility that you or your partner could become pregnant 
Who can’t take part
You cannot join this trial if any of these apply. 
 
Cancer related
You:
  • have a small cell lung cancer or a mixed small cell and non small cell lung cancer 
  • have moderate or severe side effects from the SABR treatment  
  • have had durvalumab or any other similar drug 
  • are having chemotherapy, hormone therapy Open a glossary item or another targeted drug  
  • have had another cancer unless it was non melanoma skin cancer, carcinoma in situ Open a glossary item or any other cancer that you have had treatment for more than 5 years ago and there are no signs of it coming back 
Medical conditions
You cannot join this trial if any of these apply. You: 
  • have had a major surgery in the last month 
  • have had an organ transplant Open a glossary item from a donor
  • have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the last 2 weeks unless it was a very small dose, a cream or inhaler 
  • have an autoimmune disease Open a glossary item unless it is a skin condition called vitiligo, hair loss or problems with your thyroid that are stable 
  • have problems with your immune system which means you have an increased risk of getting infections  
  • have an active infection
  • have heart problems such as an abnormal heart rhythm, congestive heart failure, angina Open a glossary item that isn’t stable or high blood pressure
  • have serious problems with your digestive system Open a glossary item that cause diarrhoea 
  • have had moderate or severe pneumonitis Open a glossary item
  • have tuberculosis
  • have HIV
  • have hepatitis B or hepatitis C 
  • are taking part or have taken part in another clinical trial looking at a new drug in the last month
  • have any other serious medical condition 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 sensitive to durvalumab or anything it contains  
  • have had a live vaccine in the last month 
  • are involved in the planning or running of this trial
  • are pregnant or breastfeeding 
  • have had a whole blood transfusion in the last 4 months 

Trial design

This is an international phase 3 trial. The researchers hope that around 630 people worldwide and between 20 to 25 people from the UK will agree to take part.
 
You join this trial after finishing the SABR treatment. This is a randomised trial. Everyone taking part is put into 1 of the following groups by computer:
  • durvalumab 
  • dummy drug 
Neither you nor your doctor can choose which treatment you have. And neither you nor your doctor will know which treatment you are having. This is a double blind trial. 


You have durvalumab or dummy drug as a drip into your bloodstream (intravenously) every 4 weeks. It takes about 60 minutes to have treatment each time. 

You continue to have treatment for as long as it is helping you and the side effects aren’t too bad. You can have treatment for up to 2 years. 
 
After 2 years, you stop durvalumab or the dummy drug and have regular check ups with your doctor. This is called follow up. If your cancer starts to grow again during follow up, you might be able to start durvalumab treatment again if you had durvalumab before. This is called the re-treatment phase. Your doctor can tell you more about this. 
 
Quality of life 
Everyone taking part completes quality of life questionnaires before the start of treatment and then:
  • every 2 weeks for 8 weeks 
  • every month for 3 months 
  • every 2 months for about 3 years 
  • every 6 months for as long as you are taking part in this trial 
The questionnaires ask about how you have been feeling and what side effects you have had. 
 
Blood tests 
You have extra blood tests as part of this trial. You have them before the start of treatment and at set times during this trial. Researchers want to:
  • find out what happens to durvalumab in your body 
  • look at the cancer DNA Open a glossary item
  • look for certain proteins (biomarkers Open a glossary item) that can help to tell why some treatments work better than others 
Researchers might also ask you to have a blood test to look at your DNA. You don’t have to agree to this if you don’t want to. You can still take part in this trial. 
 
Tissue sample
The trial team will ask to use a tissue sample of your cancer taken in the past 6 months. You need to give a new tissue sample if there isn’t a suitable sample available. 
 
Researchers want to check for the levels of a protein called PD-L1 and look for biomarkers.  

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:
  • a physical examination
  • blood tests 
  • urine test
  • a CT scan or MRI scan 
  • heart trace (electrocardiogram Open a glossary item)
  • a test to check how well your lungs work (lung function test Open a glossary item)
During treatment, you see the trial team every 2 weeks, for 8 weeks. You then see the trial team every month. You have regular blood tests and a physical examination each time you see them.
 
You also have a CT scan or MRI scan at set times during this trial. This continues for as long as the treatment is helping you and the side effects aren’t too bad. You can have treatment for up to 2 years. 
 
When you finish treatment, you see the trial team after a month. You have blood tests and a physical examination. You then see the trial team every month, or every second month for up to a year. After a year, you see or speak with the trial team every 6 months. 

Side effects

The trial team monitor you during treatment and afterwards. You 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 treatment. 
 
Durvalumab affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. Side effects can happen during treatment or some months after treatment has finished. Some side effects can be life threatening. 
 
The most common side effects of durvalumab are:
  • loose or watery poo (diarrhoea)
  • skin rashes, itching and dry skin
  • liver changes that are usually mild and unlikely to cause you any problems 
  • tiredness (fatigue)
  • feeling or being sick 
  • pain in your tummy (abdomen), muscles and joints 
  • a build up of fluid in your body causing swelling 
  • chest infections, cough and shortness of breath 
  • loss of appetite 
  • high temperature (fever)

Location

Birmingham
Leeds
London
Manchester

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

Kevin Franks

Supported by

AstraZeneca

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16043

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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