Trial of NanoPac Intratumoral Injection in Lung Cancer

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

The study team can explain what participation involves.

Who it may be forLung Cancer, Nonsmall Cell · Lung Cancer

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

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What kind of study?Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?NanOlogy, LLC

Study sponsor

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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How this study is categorized

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

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.\

Reasons someone may not be able to joinExclusion 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.

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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