Clinical trial · Interventional
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive 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 clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinflunine | Drug | Vinflunine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
- interventionNames
- Drug: Vinflunine
Primary outcomes (1)
- measure
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
- timeFrame
- 18 months
- description
- Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen * Measurable or evaluable disease * Able to perform activities of daily living with minimal assistance * Adequate hematological, liver, and kidney function * Must give written informed consent prior to entry Exclusion Criteria: * CNS involvement * Serious active infection or underlying medical condition * Significant history of uncontrolled cardiac disease
References
Publications (1)
- RESULTSpigel DR, Hainsworth JD, Lane CM, Clark B, Burris HA, Greco FA. Phase II trial of vinflunine in relapsed small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):874-8. doi: 10.1097/jto.0b013e3181d86b76. PMID 20521355