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)

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:

Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
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
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]