drugset / Trial / NCT01196078

A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

NCT01196078 ↗

Phase 4 Completed 114 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.

Timeline

Start
2007-02
Primary completion
2010-12
Completion
2010-12

Outcome

Met primary endpoint

registry NUMBER Erlotinib: 22.81 percentage of participants NUMBER Vinorelbine: 8.93 percentage of participants analysis (superiority or other test); Erlotinib vs Vinorelbine; p = 0.0388 NCT01196078 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral
Comparator Vinorelbine Small molecule 80 mg/m2 Oral