Lung Cancer Clinical Trial
Official title:
Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer
Verified date | November 2023 |
Source | NanOlogy, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
Status | Completed |
Enrollment | 18 |
Est. completion date | September 26, 2023 |
Est. primary completion date | September 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
United States | University of North Carolina Chapel Hill | Chapel Hill | North Carolina |
United States | Parkview Research Institute | Fort Wayne | Indiana |
United States | University of Florida Health | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
NanOlogy, LLC | US Biotest, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment emergent adverse events | Day 1 to Week 24 (6 Months) | ||
Secondary | Concentration of paclitaxel in the systemic circulation post-injection | Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24 | ||
Secondary | Progression free survival | Progression free survival as assessed using RECIST v1.1 | Day 1 and Weeks 24 and 52 | |
Secondary | Overall survival | As determined by survival time following first NanoPac injection | Day 1 and Week 52 | |
Secondary | Change in tumor dimensions | As determined by CT scan imaging | Day 1 and Weeks 12, 24, 38, and 52 |
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