drugset / Trial / NCT01183858

A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

NCT01183858

Phase 3 Completed 315 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib \[Tarceva\] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Timeline

Start
2010-10
Primary completion
2013-10
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral
Subject Erlotinib Small molecule 300 mg Oral