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

This study has been completed.

Sponsors and Collaborators:	OSI Pharmaceuticals National Cancer Institute of Canada
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00036647

Purpose

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).

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Tarceva (erlotinib HCl, OSI-774 )	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:

A Randomized Placebo Controlled Study of OSI-744 (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

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment:

700

Study Start Date:

October 2001

Estimated Study Completion Date:

January 2003

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036647