Clinical trial NCT04314895: Trial of NanoPac Intratumoral Injection in Lung Cancer
Official title: Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer, Nonsmall Cell
Lung Cancer
Lung Cancer, Small Cell
Neoplasm of Lung
Keywords: paclitaxel
Lead sponsor: NanOlogy, LLC
Sponsor class: INDUSTRY
Collaborators: name: US Biotest, Inc.
First posted: 2020-03-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: Day 1 to Week 24 (6 Months)
Secondary outcomes:
measure: Concentration of Paclitaxel in the Systemic Circulation Post-injection
timeFrame: Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
measure: Progression Free Survival (PFS)
timeFrame: Weeks 24, 38, and 52
measure: Overall Survival
timeFrame: Weeks 24, 38, and 52
measure: Change in Tumor Dimensions (Longest Diameter)
timeFrame: Weeks 12, 24, 38, and 52
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Research Institute
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: US Biotest, Inc.
name: Shelagh Verco, PhD
role: STUDY_DIRECTOR
References: