drugset / Trial / NCT01250119

A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.

NCT01250119 ↗

Phase 2 Completed 688 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.

Timeline

Start
2011-03
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral