Phase 2
N=18
Trial of NanoPac Intratumoral Injection in Lung Cancer
Lung Cancer, Nonsmall Cell · Lung Cancer · Lung Cancer, Small Cell · Neoplasm of Lung
Bottom Line
View on ClinicalTrials.gov: NCT04314895 ↗Enrolled (actual)
18
Serious AEs
66.7%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NanOlogy, LLC
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events |
18 | — |
| SECONDARY Concentration of Paclitaxel in the Systemic Circulation Post-injection |
566.7; 44.2; 32.8; 10685.0; 24104.0; 45523.7 | — |
| SECONDARY Progression Free Survival (PFS) |
0; 0; 5; 2; 5; 4 | — |
| SECONDARY Overall Survival |
0; 3; 6; 1; 2; 3 | — |
| SECONDARY Change in Tumor Dimensions (Longest Diameter) |
2.06; -0.23; 1.26; -0.78; 1.0; -0.85 | — |
Summary
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
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.
Data sourced from ClinicalTrials.gov (NCT04314895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.