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

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  such as cisplatin or carboplatin. You can’t take part if the chemotherapy you had included gemcitabine.
• have had at least 2 cycles  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 ) 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
• 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 ) 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 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  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 , lentigo maligna melanoma, carcinoma in situ  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  that is causing diarrhoea
• have had a heart attack in the last 6 months or a significant heart problem  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 ) or an organ transplant  in the past
• have an autoimmune condition  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 ) or moderate to severe pneumonitis caused by radiotherapy
• have a problem with how your immune system  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  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