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

OSI Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Carcinoma, Non-small-cell Lung

Treatments

Drug: Tarceva (erlotinib HCl, OSI-774 )

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00036647

BR.21

Details and patient eligibility

About

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).

Enrollment

731 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.