A study of pembrolizumab and epacadostat for advanced non small cell lung cancer (KEYNOTE-654)

The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all the following apply.
You:

• have non small cell lung cancer that has spread to another part of the body (metastatic cancer)
• haven’t had treatment for the cancer spread
• have high levels of PD-L1 in the lung cancer cells
• have cancer that the doctor can see and measure on a scan
• are willing to use reliable contraception during treatment and for 120 days afterwards if there is any chance you or your partner could become pregnant
• are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
• have satisfactory blood test results
• are at least 18 years old

Who can’t take part
You cannot join this study if any of these apply.

Cancer related
You

• have cancer that has spread to the brain unless you have had treatment, it  hasn’t got worse in the past 4 weeks and you haven’t taken steroids in the last 2 weeks before joining the study
• have certain gene mutations in the lung cancer cells including EGFR  and ALK
• have had chemotherapy or other targeted drugs
• have had pembrolizumab, epacadostat or similar drugs in the past
• have had radiotherapy within 14 days of starting study treatment or radiotherapy to the lung within 6 months
• have had steroid treatment within 7 days of starting study treatment
• have had another cancer unless this was treated with the aim to cure and there haven’t been any signs of it for at least 5 years - you can take part if you had successful treatment for basal cell skin cancer , early bladder cancer, squamous cell skin cancer,  carcinoma in situ  of the cervix  or other carcinomas in situ
•  have had an experimental treatment as part of another clinical study in the past month

Medical conditions
You:

• have, or have had, certain lung problems such as inflammation of the lungs (pneumonitis) or interstitial lung disease
• you have an autoimmune disease  and you had treatment in the past 2 years, apart from treatment to replace something that the body makes such as insulin or thyroxine
• have a collection of fluid on your lung or in your tummy (abdomen) unless you have had successful treatment
• have a problem with your immune system or you are having steroid treatment that is more than 10mg a day or any other drug that dampens down the immune system in the 7 days before starting study treatment
• have had an organ transplant or a transplant with somebody else’s stem cells
• have HIV
• have an active hepatitis B or hepatitis C infection
• have a problem with your digestive system  that might affect how you absorb the study drug
• have problems with your heart, such as a heart attack in the last 6 months, angina that is not well controlled, an abnormal rhythm of your heart or congestive heart failure
• have tuberculosis that needs treatment
• developed a condition called serotonin syndrome after having certain drugs such as phenelzine
• an active infection that needs treatment
• are sensitive to monoclonal antibodies , pembrolizumab, epacadostat or anything they contain
• have taken meperidine, linezolid, or methylene blue or similar drugs in the 21 days before starting treatment
• have any other serious medical condition or mental health problem that the study team thinks could affect you taking part

Other
You:

• are pregnant or breastfeeding
• have a problem with drugs or alcohol
• have had a live vaccine  within 30 days of starting study treatment