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Tarceva® erlotinib tablets
A therapeutic option for second-line Non-Small Cell Lung Cancer

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

National Cancer Institute of Canada (NCIC-CTG) protocol design
  • 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
Patient Characteristics

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.

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

Genentech Biooncology (OSI) Oncology

Coverage and Reimbursement Support

Tarceva Access Solutions can help.
888-249-4918

Tarceva Co-Pay Card Program

Over 300 Enrollments as of 10/23/2009

Additional Resources


Tarceva® erlotinib tablets