Trial of NanoPac Intratumoral Injection in Lung Cancer

  • End date
    Jun 7, 2023
  • participants needed
  • sponsor
    NanOlogy, LLC
Updated on 7 December 2021
total bilirubin
absolute neutrophil count
lung cancer
cancer chemotherapy
endobronchial ultrasonography
kidney function test
endobronchial ultrasound
lung carcinoma


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


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.

Condition Lung Disease, Lung Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, lung carcinoma, Lung Neoplasm, small cell carcinoma of the lung, carcinoma lung, sclc, Pulmonary Disease, small cell carcinoma, lung tumor, Bronchial Neoplasm
Treatment NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
Clinical Study IdentifierNCT04314895
SponsorNanOlogy, LLC
Last Modified on7 December 2021


Yes No Not Sure

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 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

Malignant Airway Obstruction
Known hypersensitivity to study agent
Pregnant or breastfeeding women
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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