A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Inclusion Criteria:

Aged at least 18 years
Documented evidence of NSCLC (Stage IIIB/ IV disease)
Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC
World Health Organization (WHO) Performance Status of 0 or 1
Estimated life expectancy more than 12 weeks

Exclusion Criteria:

Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4
Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
Active or prior documented autoimmune disease within the past 2 years
Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV
Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy
Known EGFR TK activating mutations or ALK rearrangements
Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)