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Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer

The primary objective of this study is to evaluate the safety and tolerability of NanoPac injected into lung cancer lesions by EBUS-TBNI on multiple (up to three) occasions, each injection procedure administered 4 weeks apart. Safety and tolerability will be assessed for 24 weeks following first NanoPac injection; with additional follow-up at weeks 38 and 52. Secondary objectives are: a) To describe the PK of NanoPac when administered into the tumor(s) within the lung; b) To evaluate effect on progression free survival (PFS) and overall survival (OS) in this population; and c) to assess changes in the treated lesion (and lymph nodes) via CT scan imaging, histology, and immunochemistry (IHC).

The primary objective of this study is to evaluate the safety and tolerability of NanoPac injected into lung cancer lesions by EBUS-TBNI on multiple (up to three) occasions, each injection procedure administered 4 weeks apart. Safety and tolerability will be assessed for 24 weeks following first NanoPac injection; with additional follow-up at weeks 38 and 52. Secondary objectives are: a) To describe the PK of NanoPac when administered into the tumor(s) within the lung; b) To evaluate effect on progression free survival (PFS) and overall survival (OS) in this population; and c) to assess changes in the treated lesion (and lymph nodes) via CT scan imaging, histology, and immunochemistry (IHC).