Clinical trial · Interventional
Trial of NanoPac Intratumoral Injection in Lung Cancer
Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer
NCT04314895CI-TRIAL-00090121completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Cancer, Small Cell | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Neoplasm of Lung | Lung Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NanoPac
- description
- 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.
- interventionNames
- Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
Primary outcomes (1)
- measure
- Number of Participants With Treatment Emergent Adverse Events
- timeFrame
- Day 1 to Week 24 (6 Months)
- description
- 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.
Secondary outcomes (4)
- measure
- Concentration of Paclitaxel in the Systemic Circulation Post-injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.