NCT00036647

OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 731 (actual)
• Sponsor: OSI Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).

Conditions

• Carcinoma, Non-small-cell Lung

Interventions

Type	Name	Description
DRUG	Tarceva (erlotinib HCl, OSI-774 )

Timeline

• Start date: 2001-11-01
• Primary completion: 2004-01-30
• Completion: 2004-01-30
• First posted: 2002-05-14
• Last updated: 2018-01-10

Locations

97 sites across 17 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Germany, Greece, Israel, Mexico, New Zealand, Romania, Singapore, South Africa, Sweden, Thailand