A trial looking at pembrolizumab and chemotherapy for advanced non small cell lung cancer (KEYNOTE-789)

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 non small cell lung cancer that is stage 4
• you have a change (mutation) in receptors called epidermal growth factor receptors (EGFR)
• your cancer came back and got worse after treatment with a type of cancer growth blocker called a tyrosine kinase inhibitor such as erlotinib and afatinib
• you have at least 1 area of cancer that can be seen and measured on a scan
• you are willing to have a sample of your cancer taken (a biopsy ) if there isn’t a suitable sample available taken after you finished your last cancer treatment
• you are at least 18 years old
• you are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
• you have satisfactory blood test results
• you are willing to use reliable contraception during treatment and for up to 6 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

• your NSCLC has spread to the brain or the membranes surrounding the brain (carcinomatous meningitis) unless you have had treatment, it has been stable for the past 4 weeks and you have stopped taking steroids more than 2 weeks ago
• your NSCLC is mainly a type called squamous cell cancer 
• you have fluid in your lung (pleural effusion) or a collection of fluid in the abdomen (ascites) that is causing symptoms (you may be able to take part if you have had treatment and the symptoms are stable) 
• you have had treatment with pembrolizumab or any other similar drug
• you have had treatment that reached your whole body (systemic treatment) for advanced NSCLC unless it was a tyrosine kinase inhibitor or chemotherapy that you had before surgery (neo adjuvant therapy) or after surgery (adjuvant therapy)
• you have had radiotherapy in the past 2 weeks and you still have side effects from it (one week if it was radiotherapy to help with symptoms and 6 months if it was a large dose of radiotherapy to your lungs)
• you have had another cancer in the last 5 years unless it was non melanoma skin cancer or an early cancer (carcinoma in situ ) of the bladder or breast that have been successfully treated

Medical conditions

You:

• have had treatment with a new drug or device in the last 4 weeks
• take drugs that damp down your immune system such as steroids unless it is a very small dose
• have an autoimmune disease  that needed systemic treatment in the last 2 weeks, unless it was treatment to replace something that the body makes such as insulin or thyroxine
• have lung problems such as pneumonitis  
• have an active infection that needs systemic treatment
• have HIV
• have hepatitis B or hepatitis C
• have active tuberculosis
• have any other serious condition or mental health problem that the trial team think could affect you taking part

Other

You:

• are pregnant or breastfeeding 
• have had a live vaccine in the past 30 days
• are sensitive to the drugs used in this trial or anything they contain