CompletedPhase 2NCT04314895

Trial of NanoPac Intratumoral Injection in Lung Cancer

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

Checked against the public recordLast updated May 23, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations4
SponsorNanOlogy, LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
NanOlogy, LLC
Interventions being studied
Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • University of Florida HealthGainesville, Florida
  • Parkview Research InstituteFort Wayne, Indiana
  • Johns HopkinsBaltimore, Maryland
  • University of North Carolina Chapel HillChapel Hill, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 23, 2025. Always confirm current availability with the study team.

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