Non-Small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DRUGVinflunine
320 mg/m2 as a 20-minute IV infusion
Sponsors
Bristol-Myers Squibb
Veeda Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the 1-year survival rate in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. | unk |
Secondary
| Measure | Time frame |
|---|---|
| To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. | unk |
| To determine the progression-free survival (PFS) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet | unk |
| To assess time to response (TTR) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. | unk |
| To assess response rate (RR) of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet. | unk |
| To assess duration of stable disease in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. | unk |
| To assess the safety of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet. | unk |
| To assess duration of overall response in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. | unk |
Countries
United States
Outcome results
None listed