Lung Cancer Clinical Trial

Trial of NanoPac Intratumoral Injection in Lung Cancer

Summary

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

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Full 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.

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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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT04314895

Recruitment Status:

Recruiting

Sponsor:

NanOlogy, LLC

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There are 4 Locations for this study

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University of Florida Health
Gainesville Florida, 32610, United States More Info
Erin Silverman
Contact
352-273-5870
[email protected]
Hiren Mehta, MD
Principal Investigator
Parkview Research Institute
Fort Wayne Indiana, 46845, United States More Info
Jon Lehrman
Contact
260-266-6633
[email protected]
Abhishek Biswas, MD
Principal Investigator
Johns Hopkins
Baltimore Maryland, 21205, United States More Info
Jenna Los
Contact
410-955-5288
[email protected]
Christine Argento, MD
Principal Investigator
University of North Carolina Chapel Hill
Chapel Hill North Carolina, 27599, United States More Info
Ashley Delgado
Contact
919-349-0496
[email protected]
Jason Akulian, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT04314895

Recruitment Status:

Recruiting

Sponsor:


NanOlogy, LLC

How clear is this clinincal trial information?

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