A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer

Summary

This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural effusion) and IV NSCLC who have been previously treated with a platinum-based doublet. Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320 mg/m2 as a 20-minute IV infusion. Patients will continue to receive study treatment until disease progression or unacceptable toxicity. Patients will be evaluated every 2 cycles for response using RECIST criteria.

Timeline

Start

2005-10

Primary completion

2008-03

Completion

2008-03

Drugs

Indications