Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC

Overview

Title: Randomized cross-over study of patient preference for oral or intravenous vinorelbine in the treatment of advanced NSCLC. A phase IV study. ShortTitle/ Acronym: VIVOS Protocol Code :IRST162.05 Study Design: Randomized, open label cross-over study Study Duration: Two years Study Center(s): Multicenter study Objectives: Primary: Patient preference for oral or intravenous vinorelbine Secondary: Overall Response Rate, Time to Progression, Toxicity, Survival, Subjective reasons for treatment choice. Number of Subjects: 120 Diagnosis and Main Inclusion Criteria: Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line chemotherapy with vinorelbine due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2 Study Product, Dose, Route, Regimen and duration of administration : * Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine (60mg/m2) * Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV vinorelbine (30mg/m2) In both arms vinorelbine will be given at day 1 and day 8 every 3 weeks. From the third cycle onwards patients will have to choose to receive oral or intravenous vinorelbine. Vinorelbine capsules will be administered at the dosage of 60 mg/m2 for the first course and then may be increased to 80 mg/m² at physician's choice. Treatment will be repeated every 21 days and continued until disease progression, intolerable toxicity or patient refusal. Reference therapy: Vinorelbine 30 mg/m2 intravenous day 1 and 8 every 21 days Statistical Methodology: The sample size is calculated based on 75% of patients preferring "oral" vinorelbine and 25% preferring "intravenous" vinorelbine. Therefore, the investigators would compare patients preferring "oral" vinorelbine as 75% compared to a null hypothesis of 50% (no difference in proportion of patients preferring "oral" to "intravenous"). With 80% power and a total alpha of 0.05, the estimated sample size is 60 for group (120 total). During recruitment period, a formal interim analysis was planned when 60 patients (30 for group) have been enrolled, with a p-value \<0.0001. To claim statistical significance in the final analysis, the overall p-value is still 5% (referred to Peto-Haybittle rule).