Trial of NanoPac Intratumoral Injection in Lung Cancer

Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Lung Cancer, Nonsmall Cell; Neoplasm of Lung; Lung Cancer, Small Cell
• Intervention / Treatment: Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

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 into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Health
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Institute
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-1350
      • University of North Carolina Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NanoPac; Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.

Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension; NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles within a well-characterized particle-size distribution. Following PCA, NanoPac is filled into a clear 60mL Type 1, USP, clear-glass vial (306 mg/vial) as a powder fill of nanoparticulate paclitaxel, closed with a bromobutyl rubber stopper and aluminum crimp seal, and sterilized by gamma irradiation. Prior to administration at the hospital/clinic, NanoPac will be reconstituted with 1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP, to form a suspension. The suspension will be further diluted with 0.9% Sodium Chloride for Injection, USP to achieve the final clinical formulation.; Other Names: paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events	AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	Day 1 to Week 24 (6 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Paclitaxel in the Systemic Circulation Post-injection	To characterize the pharmacokinetics of intratumoral NanoPac, plasma samples were taken on days of NanoPac injection prior to injection and at 1, 2, and 4 hours after NanoPac injection, as well as at all other study visits up through Week 24. Plasma paclitaxel concentrations are reported in pg/mL.	Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
Progression Free Survival (PFS)	Progression free survival (PFS) as assessed using RECIST v1.1	Weeks 24, 38, and 52
Overall Survival	Overall survival (OS) as determined by survival time following first NanoPac injection	Weeks 24, 38, and 52
Change in Tumor Dimensions (Longest Diameter)	Change in longest dimension (cm) as determined by CT imaging compared to baseline (Screening)	Weeks 12, 24, 38, and 52

Collaborators and Investigators

• Sponsor: NanOlogy, LLC
• Collaborators: US Biotest, Inc.
• Investigators: Study Director: Shelagh Verco, PhD, US Biotest, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: paclitaxel
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Albumin-Bound Paclitaxel; Paclitaxel
• Other Study ID Numbers: NANOPAC-2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No