Non Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Phase 2 Study of Erlotinib (Tarceva®) in Combination With OSI-906 or Placebo in Chemonaive Patients With Advanced NSCLC With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene
A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are Chemonaive.
Based on the recommendation of the Data Monitoring Committee, OSI-906 and matching placebo
are no longer being administered as of 01 March 2013.
This is a multi-center, randomized (1:1), double-blind, placebo-controlled, phase 2 study.
Patients will be stratified according to the following 2 parameters: (1) EGFR activating
mutation type (exon 19 deletion versus exon 21 single point mutation); and (2) Eastern
Cooperative Oncology Group (ECOG) performance status (0 vs. 1).
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