Study of 1st Line Therapy Study of Durvalumab With Tremelimumab Versus SoC in Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE).

Patients will be randomized in a 1:1 to receive treatment with durvalumab + tremelimumab
combination therapy or SoC therapy. The primary objective of this study is to assess the
efficacy of combination treatment compared with SoC in terms of Overall Survival (OS) in
patients.

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 activating 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

- No Prior exposure to IMT, including, but not limited to, other antiCTLA4, antiPD1,
anti PDL1,or antiPDL2 antibodies, excluding therapeutic anticancer vaccines

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 the patient is stable
(asymptomatic; no evidence of new or emerging brain metastases) and off steroids for
at least 14 days prior to start of study treatment.

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