A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

This study is designed to investigate the efficacy, safety, tolerability of a new drug,
MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung
Cancer. MEDI4736 will be investigated in patients who have received at least two prior
treatment regimens including one platinum-based chemotherapy

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)