Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

Inclusion Criteria:

- Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous
histology that is not amenable to therapy with curative intent (surgery or radiation
therapy with or without chemotherapy).

- No prior treatment with systemic anti-cancer therapy for Stage IV disease.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.

- Measurable disease by computed tomography or magnetic resonance imaging per RECIST
v1.1.

- Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by
the central laboratory prior to randomization.

- Other protocol inclusion criteria may apply

Exclusion Criteria:

- Known epidermal growth factor receptor (EGFR) mutations sensitive to available
targeted inhibitor therapy.

- Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.

- Untreated central nervous system (CNS) metastases.

- Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central
laboratory.

- Carcinomatous meningitis.

- Active, known or suspected autoimmune disease.

- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1
targeted agent, or any other antibody or drug targeting T cell co-stimulation or
checkpoint pathways.

- History of allergy or hypersensitivity to platinum-containing compounds or study drug
components.

- Physical and laboratory test findings outside the protocol-defined range.

- Other protocol exclusion criteria may apply.