Tarceva.net

Rigorously designed NCIC protocol

• National Cancer Institute of Canada, double-blind, placebo-controlled Phase III trial (BR.21) evaluated Tarceva 150 mg monotherapy, randomized 2:1 versus placebo in second- and third-line patients with Stage IIIB or IV NSCLC. ^[1,2]

 

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

Well-balanced patient population

• 731 patients diagnosed with locally advanced or metastatic NSCLC. ^[1]
• Demographic characteristics were well balanced. ^[1]
• Patients were not preselected to enrich the study population for favorable prognostic factors, such as gender, smoking status, or tumor histology. ^[3]

*Stratification factor as documented at baseline; distribution differs slightly from values
reported at time of randomization. ^[3]

†Approximately 1/2 of patients (n=326) had EGFR protein expression status characterized;
however, EGFR status was not a selection criterion for entry into the single-agent Phase III clinical trial. ^[1,3]

References

1. Tarceva® (erlotinib) summary of product characteristics. F. Hoffmann-La Roche Ltd., 2007.
2. Shepherd FA, Pereira JR, Ciuleanu T, et al, for the National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non–small-cell lung cancer. N Engl J Med. 2005;353:123-132. 
3. Data on file, OSI Pharmaceuticals, Inc.