Clinical trial · Interventional
Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
- 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 is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| NPI-2358 + docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- docetaxel
- description
- docetaxel (75 mg/m2)
- interventionNames
- Drug: docetaxel
- type
- EXPERIMENTAL
- label
- NPI-2358 + docetaxel
- description
- NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
- interventionNames
- Drug: NPI-2358 + docetaxel
Primary outcomes (1)
- measure
- Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
- timeFrame
- Continuous
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and females ≥ 18 years of age * ECOG performance status ≤ 1 * Pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable Stage IIIb or IV) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial * All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade ≤ 2 * Signed informed consent Exclusion Criteria: * Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames * Significant cardiac history * Prior treatment with tumor vascular disruptive agents * Seizure disorder * Brain metastases * Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy * Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C * Patients with a prior hypersensitivity reaction to product components * Pregnant or breast-feeding women. * Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix * Unwilling or unable to comply with procedures required in this protocol
References
Publications (0)
Data not yet available