Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2

Core Inclusion Criteria:

• Histologically confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab.
• Eastern Cooperative Oncology Group (ECOG) performance status 2.
• Life expectancy > 12 weeks.
• Uni-dimensionally measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
• Computerised Tomography (CT) scan of chest and abdomen within 28 days of starting pembrolizumab.
• Adequate haematological function:
• Platelet count ≥100 x 109 /L.
• Neutrophils ≥1.5 x 109/L.
• Haemoglobin ≥ 90 g/L.
• Adequate hepatic function:
• Serum bilirubin ≤1.5 x upper limit of normal (ULN).
• Serum transaminases ≤2.5 x ULN.
• Adequate renal function: Creatinine clearance 50 ml/min.
• Provision of signed and dated, written informed consent prior to any trial specific procedures, sampling and analyses.

Core Exclusion Criteria:

• Patients who do not meet the criteria of performance status = 2 on the ECOG Performance scale.
• Untreated symptomatic brain or leptomeningeal metastatic disease.
• Medical or psychiatric conditions compromising informed consent.
• Any medical condition which in the opinion of the investigator would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol.
• Radiotherapy within 28 days of trial treatment.
• Active autoimmune disease that has required systemic treatment in past 2 years
• Chronic usage of steroids or other immunosuppressant medication.
• Previous history of pneumonitis.
• Any evidence of clinical autoimmunity.