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

This is an interventional treatment trial for Lung Cancer focused on measuring Non-small cell lung cancer, programmed cell death protein 1 (PD-1) antibody, indoleamine 2,3-dioxygenase (IDO) inhibitor Read More

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.