A trial looking at durvalumab and tremelimumab for non small cell lung cancer (POSEIDON)

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 4 NSCLC and you can’t have treatment, such as surgery or radiotherapy, to try to cure your cancer
• don’t have a change (mutation) in receptors called epidermal growth factor receptors (EGFR) or a type of the ALK gene called ALK fusion
• are going to have treatment for NSCLC that reaches your whole body (systemic) for the 1st time. You might be able to take part if you had a platinum drug that was part of a treatment to try to cure your cancer more than a year ago   
• have a suitable sample of cancer available that is less than 3 months old (or be willing to have a sample taken) that the team can test for a biomarker  called PD-L1
• have at least 1 area of cancer that can be seen and measured on a scan 
• you have satisfactory blood tests results and you haven't had a blood transfusion in the past 4 weeks
• are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) 
• are at least 18 years old  
• are willing to use reliable contraception during treatment and for 3 months after the final dose of durvalumab, or 6 months after the final dose of durvalumab and tremelimumab, if there is any possibility 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 type of NSCLC called sarcomatoid or mixed small-cell lung cancer
• have NSCLC that has spread to the tissues surrounding the spinal cord  
• have NSCLC that has spread to your brain or the tissues surrounding your brain, unless it’s stable and you haven’t taken steroids in the past 2 weeks
• have had durvalumab, tremelimumab or any other similar drugs 
• are having treatment for your cancer with chemotherapy, a targeted cancer drug (biological therapy), an experimental treatment or hormone therapy
• have had a major surgery in the last 28 days (you may be able to take part if it was a small operation to remove some of the cancer and help with symptoms)
• have had radiotherapy in the past, unless you have finished it more than a year ago, or it was given to help with symptoms (palliative radiotherapy)
• have had a donor transplant (allogeneic transplant )
• have had another cancer in the last 5 years apart from cancers that haven’t spread (carcinoma in situ ) or basal or squamous cell skin cancer that have been successfully treated

Medical conditions
You:

• weigh less than 30 kg (4 stone 10lb)
• are taking part in another clinical trial or you have had an experimental treatment in the past year
• can’t have treatment with a platinum drug for any reason
• have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks, unless it was a very small dose, an inhaler or a cream  
• have HIV
• have hepatitis B or hepatitis C
• have had or have active tuberculosis 
• have an infection that needs treatment
• have heart problems such as congestive heart failure, high blood pressure that isn’t controlled by medication or angina that is not controlled 
• have problems with your digestive system  such as colitis or Crohn’s disease 
• have an autoimmune disease
• have had a live vaccine  in the past 30 days 
• have any other serious medical condition or mental health problem that the trial team thinks could affect you taking part 

Other
You:

• are pregnant or breastfeeding
• are sensitive to tremelimumab, durvalumab or anything they contain