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

• Status: Completed
• Trial end date: 2004-01-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OSI Pharmaceuticals
• Collaborators: Canadian Cancer Trials Group; NCIC Clinical Trials Group
• Treatments: Erlotinib Hydrochloride

Criteria

• Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.

• Must have evidence of disease (clinical or radiological).

• Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.

• If the patient has had surgery, the surgery was at least 2 weeks ago.

• Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms.

• If the patient received radiation therapy, treatment was at least 4 weeks ago.