Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

Inclusion Criteria

• Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
• Age 18 years or older
• Body weight ≥ 35 kg
• Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
• Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study
• Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1 Main

Exclusion Criteria

• Mixed small cell and non-small cell lung cancer histology
• Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug
• Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC
• Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
• Subjects with a history of venous thrombosis within the past 3 months
• Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
• Congestive heart failure
• Active or prior documented autoimmune or inflammatory disorders
• History of active primary immunodeficiency
• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
• History of allogenic organ transplantation
• QTcF interval ≥ 470 ms
• History of another primary malignancy
• Concurrent enrollment in another clinical study [concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted]
• Females who are pregnant, lactating, or intend to become pregnant during their participation in the study