A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.

Summary

This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Timeline

Start

2007-08

Primary completion

2009-02

Completion

2009-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Gemcitabine vs Erlotinib + Gemcitabine; p = 0.3644; Hazard Ratio (HR) 1.842 (95% CI 0.483 to 7.027); Log Rank NCT00518011 ↗

Drugs

Indications