A trial of durvalumab, oleclumab and monalizumab for non small cell lung cancer (PACIFIC-9)

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 cancer that has grown into nearby tissues or lymph nodes  and you can’t have surgery to remove it (stage 3 lung cancer)
• are having or have had chemotherapy and radiotherapy together (chemoradiotherapy)
• have had at least 2 cycles of chemoradiotherapy which included a platinum drug  alongside certain other chemotherapy drugs. Your doctor will know this.
• have had a certain dose of radiotherapy using either intensity modulated radiotherapy (IMRT  or 3D conformal radiotherapy) . You doctor will know this.
• had a PET-CT scan within 3 months of starting chemoradiotherapy 
• have a sample of cancer tissue (biopsy)  available for the trial team to do some tests on
• have cancer with certain gene changes (mutations)  in the lung cancer cells. The trial team test for these.
• are active but might not be able to do heavy physical work (performance status 0 or 1)
• weigh at least 40kg
• have satisfactory blood test results
• are willing to use reliable contraception during the trial and for a period after
• 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 a mix of small cell and non small cell lung cancer
• are going to have surgery as part of your routine treatment. For example you have a Pancoast tumours.
• have cancer spread to the tissues around the brain (leptomeningeal carcinomatosis)
• have cancer that has grown into major blood arteries such as the artery that supplies the lung or the heart
• have cancer that has the gene changes (mutations ) EGFR or ALK. Your doctor will know this. 
• have gene changes in the lung cancer cells that include ROS1, RET, MET, NTRK1, NTRK2 and ERBB2. Your doctor will know about this.
• had chemotherapy before radiotherapy rather than having them at the same time for stage 3 non small cell lung cancer
• have cancer that got worse during chemoradiotherapy that included a platinum drug
• have or are having treatment for stage 3 NSCLC that included an immunotherapy, an experimental drug, radiotherapy or a type of drug called a monoclonal antibody
• have had durvalumab, monalizumab, or oleclumab in the past 
• took part in a trial looking at durvalumab, monalizumab, or oleclumab even if you didn’t have these treatments
• still have moderate to severe side effects from chemoradiotherapy
• have had previous treatment with some types of immunotherapy. You doctor will know which ones these are.
• have ongoing side effects from an immunotherapy that is caused by the immune system
• are taking part in another trial unless it doesn’t involve a treatment or you took part in a clinical trial in the last 3 months
• have had another cancer that has got worse or needed treatment in the past 5 years unless it has a low chance of coming back. You can join if it was successfully treated non melanoma skin cancer , very early melanoma skin cancer, carcinoma in situ or very early cancers that can be treated with the aim to cure.

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

• 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 a stroke or mini stroke in the last 6 months
• have had a lung clot in the last 6 months or a clot somewhere else in the body in the last 3 months
• have an abnormal heart rhythm 
• have high blood pressure that isn’t well controlled with medication
• have a bleeding problem
• have lung damage or inflammation of the lungs
• have an active hepatitis B infection, hepatitis C infection, HIV, active tuberculosis or any other serious infection that needs treatment
• have a serious long term problem with your digestive system  or any condition that causes diarrhoea 
• have an autoimmune disease . You can still take part if you have certain autoimmune diseases. Your doctor can tell you about this.
• have a problem with how your immune system  works
• have had a bone marrow or stem cell transplant with someone else’s cells (allogeneic transplant )
• might need to have another treatment for cancer
• are having or have had treatment for non small cancer that includes radiotherapy, chemotherapy or monoclonal antibody  or an experimental treatment
• have had an immunotherapy in the past
• have medication that damps down the immune system within 14 days of starting durvalumab. You can join if you had low dose steroids.
• have had major surgery or a bad injury within 4 weeks of starting trial treatment or you might need major surgery while you are having trial treatment
• have any other 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:

• have had a live vaccination  within 30 days of the starting trial treatment
• are allergic to durvalumab, oleclumab or monalizumab or anything they contain
• are pregnant or breastfeeding