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

Main 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 therapeutic clinical study or during the follow-up period of an interventional study. Enrollment in observational studies will be allowed
Females who are pregnant, lactating, or intend to become pregnant during their participation in the study