Clinical Trial Design

Tarceva (erlotinib) is the first and only oral agent proven to significantly prolong survival in second-line advanced NSCLC¹

Tarceva inhibits ATP binding to HER1/EGFR tyrosine kinase in normal and tumor cells; its clinical antitumor activity has yet to be fully characterized.¹

• Tarceva was approved on the basis of a randomized, double-blind, placebo-controlled Phase III trial for second- and third-line patients with Stage IIIB or IV NSCLC.¹
• The trial included patients with performance status of 0 to 3.¹
• Patients were not preselected to enrich the study population for favorable prognostic factors, such as gender, smoking status, tumor histology, prior chemotherapy or ECOG performance status.²

Indication and Usage

Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Results from two, multicenter, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.

• Please see full prescribing information

• 1. Tarceva® (erlotinib) full prescribing information,OSI Pharmaceuticals,Inc., 2009.
• 2. Data on file, OSI Pharmaceuticals, Inc.