Lung Cancer, Nonsmall CellPhase 2NCT04314895
Trial of NanoPac Intratumoral Injection in Lung Cancer
A Phase 2 study testing NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension in people with Lung Cancer, Nonsmall Cell and Lung Cancer, run by NanOlogy, LLC at 4 sites in United States.
Trial summary
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell, Lung Cancer, Lung Cancer, Small Cell
- What is being tested?
- NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Apr 2021to 26 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.*
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins
Baltimore, Maryland, 21205
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599-1350
Parkview Research Institute
Fort Wayne, Indiana, 46845
University of Florida Health
Gainesville, Florida, 32610
About this study
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
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
Read the 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.
- Being tested
- NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
- Keywords
- paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoPac (sterile nanoparticulate paclitaxel) Powder for SuspensionDrug
Also called paclitaxel
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.
| Study group | Role | What they receive |
|---|---|---|
| NanoPac | Experimental | 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. Receives: Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Week 24 (6 Months)
Secondary outcomes (4)
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.
Measured: 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
Measured: Weeks 24, 38, and 52
Overall Survival
Overall survival (OS) as determined by survival time following first NanoPac injection
Measured: 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)
Measured: Weeks 12, 24, 38, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start14 Apr 2021
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanOlogy, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Biotest, Inc.
- Responsible party
- Sponsor
- Investigators
- Shelagh Verco, PhD, Study director, US Biotest, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314895
- Sponsor's protocol ID
- NANOPAC-2020-01
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2020
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04314895
- Acronym / sponsor ID
- NANOPAC-2020-01
- Keywords
- paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NanOlogy, LLCIndustry (pharma, biotech, devices)
- Collaborators
- US Biotest, Inc.
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NanoPac | Experimental | Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for SuspensionIntratumoral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoPac (sterile nanoparticulate paclitaxel) Powder for SuspensionAlso: paclitaxelNanoPac 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. | Drug | NanoPac |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: Day 1 to Week 24 (6 Months)
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.
4 secondary outcomes
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Time frame: Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
Progression Free Survival (PFS)
Time frame: Weeks 24, 38, and 52
Overall Survival
Time frame: Weeks 24, 38, and 52
Change in Tumor Dimensions (Longest Diameter)
Time frame: Weeks 12, 24, 38, and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelagh Verco, PhD study director
US Biotest, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension in people with Lung Cancer, Nonsmall Cell and Lung Cancer, run by NanOlogy, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (time frame: Day 1 to Week 24 (6 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.