Trial of NanoPac Intratumoral Injection in Lung Cancer

Inclusion Criteria:

• Signed informed consent;

• Age ≥18 years and able to tolerate the EBUS-TBNI procedure;

• Histologically/cytologically confirmed lung cancer. Eligible subjects may include,for example: primary or recurrent non-resectable disease, locally advanced stages IIand III with nodal disease, stage IV advanced disease;

• At least one lesion documented via imaging (within 4 weeks of Screening) which canbe accessed using EBUS-TBNI;

• Subject is not a candidate for surgery;

• Has received or plans to receive SOC chemotherapy; adequate hematologic recoverymust be confirmed according to the institution's SOC;

• Performance Status (ECOG) 0-2 at study entry;

• Life expectancy of at least 6 months;

• Adequate marrow, liver, and renal function at study entry;

• ANC ≥ 1.5 x 109/L;

• Hemoglobin ≥ 9.0 grams/dL;

• Platelets ≥ 75 x 109/L;

• Total bilirubin ≤ 1.5x institutional ULN;

• AST/ ALT ≤ 2.5x institutional ULN;

• Creatinine ≤ 1.5x institutional ULN;

• Appropriate steps taken to minimize or avoid the potential for pregnancy forsubjects of child-bearing potential.*

Exclusion Criteria:

• Significant cardiac disease (Class III or IV per New York Heart Associationguidelines);

• Active bacterial, viral, or fungal infections (including active AIDS, hepatitis B orhepatitis C);

• Symptomatic central nervous system (CNS) metastasis which are neurologicallyunstable, or CNS disease requiring increase in steroid dose (treated metastaticdisease and stable steroid use are not excluded)

• Known hypersensitivity to study agent;

• Pregnant or breastfeeding women.