A Global Study to Assess the Effects of MEDI4736 (Durvalumab) 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 and at least 1 additional regimen for treatment of NSCLC
• World Health Organisation (WHO) Performance Status of 0 or 1
• Estimated life expectancy of more than 12 weeks
• Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))

Exclusion Criteria

• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
• Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
• Active or prior autoimmune disease or history of immunodeficiency
• Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
• Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
• Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.
• 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)