Trial of NanoPac Intratumoral Injection in Lung Cancer

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

This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.

NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.

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 II and III with nodal disease, stage IV advanced disease;

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

• Subject is not a candidate for surgery;

• Has received or plans to receive SOC chemotherapy; adequate hematologic recovery must 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 for subjects of child-bearing potential.*

Exclusion Criteria:

• Significant cardiac disease (Class III or IV per New York Heart Association guidelines);
• Active bacterial, viral, or fungal infections (including active AIDS, hepatitis B or hepatitis C);
• Symptomatic central nervous system (CNS) metastasis which are neurologically unstable, or CNS disease requiring increase in steroid dose (treated metastatic disease and stable steroid use are not excluded)
• Known hypersensitivity to study agent;
• Pregnant or breastfeeding women.