Trial of NanoPac Intratumoral Injection in Lung Cancer

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

Detailed Description
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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.

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

Conditions
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Lung Cancer, Nonsmall Cell, Lung Cancer, Lung Cancer, Small Cell, Neoplasm of Lung

Intervention / Treatment
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* Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NanoPac<br>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<br>* 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.<br>* Other names: paclitaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment emergent adverse events |  | 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 |  | Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24 | 
| Progression free survival | Progression free survival as assessed using RECIST v1.1 | Day 1 and Weeks 24 and 52 | 
| Overall survival | As determined by survival time following first NanoPac injection | Day 1 and Week 52 | 
| Change in tumor dimensions | As determined by CT scan imaging | Day 1 and Weeks 12, 24, 38, and 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel