NCT01221077

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• NSCLC
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	OSI-906	As of 01 March 2013, OSI-906 is no longer being administered
DRUG	Erlotinib	Erlotinib administered orally
DRUG	Placebo	As of 01 March 2013, the matching placebo is no longer being administered

Timeline

• Start date: 2011-04-08
• Primary completion: 2013-03-01
• Completion: 2014-09-01
• First posted: 2010-10-14
• Last updated: 2025-11-18

Locations

29 sites across 6 countries: United States, Canada, Hong Kong, Singapore, South Korea, Thailand