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

Inclusion Criteria: To be eligible for the study, patients must fulfill all of the following criteria: * Patients must have signed an IRB-approved informed consent. * Patients must have recurrent or metastatic stage IIIB (with malignant pleural effusion) and IV NSCLC that has progressed after receiving a platinum-based doublet as first-line therapy. * Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Previously irradiated lesions will not be allowed as measurable disease. * Patients must have an ECOG Performance Status of 0, 1, or 2. * Patients must be \<18 years of age. * Previous chemotherapy must have been completed at least 4 weeks prior to enrollment. * Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months. * Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter. * Patients must have an absolute neutrophil count (ANC) \>1500/uL, platelet count \>100,000/uL, and hemoglobin \>8 g/dL. * Patients must have a serum creatinine \<2 x institutional upper limit of normal (ULN). * Patients must have a total bilirubin \<2.5 x ULN and aspartate transaminase (AST) \<5.0 x ULN. Exclusion Criteria: Any of the following criteria will make the patient ineligible to participate in this study: * Patients previously treated with vinflunine or another vinca alkaloid. * Patients with untreated and clinically unstable brain metastases. * Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. * Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. * Patient has a co-existing malignancy or had a malignancy diagnosed within the last 3 years, with the exception of basal cell carcinoma or cervical cancer in situ. * Patient received treatment with a non-approved or investigational drug within 30 days before planned start of study treatment. * Patient is not completely healed from a previous oncologic or other major surgery. * Patient is receiving or planning to receive any concurrent chemotherapy not indicated in the study protocol or an investigational agent during the study period. * Patients who have a history of hypersensitivity to vinflunine or any of the components in vinflunine or another vinca alkaloid. * Any patient who is pregnant or lactating. * Any patient who is unable to comply with requirements of study.