Status:
COMPLETED
Trial of NanoPac Intratumoral Injection in Lung Cancer
Lead Sponsor:
NanOlogy, LLC
Collaborating Sponsors:
US Biotest, Inc.
Conditions:
Lung Cancer, Nonsmall Cell
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04314895
Start Date
April 14 2021
End Date
September 26 2023
Last Update
May 23 2025
Active Locations (4)
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1
University of Florida Health
Gainesville, Florida, United States, 32610
2
Parkview Research Institute
Fort Wayne, Indiana, United States, 46845
3
Johns Hopkins
Baltimore, Maryland, United States, 21205
4
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-1350