A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

Summary

This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason.

Timeline

Start

2011-05-23

Primary completion

2016-12-20

Completion

2016-12-20

Outcome

Met primary endpoint

registry analysis (superiority test); Erlotinib; p = 0.005; Hazard Ratio (HR) 0.58 (95% CI 0.41 to 0.83); Log Rank NCT01174563 ↗

Drugs

Indications