Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC).

Patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 +
tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

- Aged at least 18 years

- Documented evidence of Stage IV NSCLC

- No sensitizing EGFR mutation or ALK rearrangement

- No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC

- World Health Organization (WHO) Performance Status of 0 or 1

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are
fulfilled:

1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable
(not requiring steroids)

3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other
anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1
(PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies,
excluding therapeutic anticancer vaccines

4. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn's disease]