A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study
of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small
Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based,
Concurrent Chemoradiation Therapy (PACIFIC)

Inclusion Criteria:

1. Age at least 18 years.

2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)

3. Patients must have received at least 2 cycles of platinum-based chemotherapy
concurrent with radiation therapy.

4. World Health Organisation (WHO) Performance Status of 0 to 1.

5. Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.

2. Active or prior autoimmune disease or history of immunodeficiency.

3. Evidence of severe or uncontrolled systemic diseases, including active bleeding
diatheses or active infections including hepatitis B, C and HIV.

4. Evidence of uncontrolled illness such as symptomatic congestive heart failure,
uncontrolled hypertension or unstable angina pectoris.

5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.

6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative
colitis).