Trial of NanoPac Intratumoral Injection in Lung Cancer
Completed · Phase 2
Conditions studied: Lung Cancer, Nonsmall Cell, Lung Cancer, Lung Cancer, Small Cell, Neoplasm of Lung
In brief
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
Key facts
- Study ID
- NCT04314895
- Run by
- NanOlogy, LLC
- People needed
- 18
- Starts
- 2021-04-14
- Expected to finish
- 2023-09-26
- Last updated by the study team
- 2025-05-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.*
You may not qualify if…
- 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.
Where it is running
- University of Florida Health — Gainesville, Florida, United States
- Parkview Research Institute — Fort Wayne, Indiana, United States
- Johns Hopkins — Baltimore, Maryland, United States
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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