References
- Tarceva® (erlotinib) summary of product characteristics. F. Hoffmann-La Roche Ltd., 2007.
- 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.
- Data on file, OSI Pharmaceuticals, Inc.
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]
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
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