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

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

This study has been completed.

Study NCT00036647. Last updated on December 16, 2005. Information provided by OSI Pharmaceuticals

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

Brief 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).

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Carcinoma, Non-Small-Cell Lung

Intervention ^†

Drug: Tarceva (erlotinib HCl, OSI-774 )

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

700

Start Date ^†

October 2001

Completion Date

January 2003

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Australia, Brazil, Canada, Chile, China, Germany, Greece, Israel, Mexico, New Zealand, Romania, Singapore, South Africa, Sweden, Thailand

Administrative Information Fields

NCT ID ^†

NCT00036647

Organization ID

OSI-774-BR.21

Secondary IDs ^††

Study Sponsor ^†

OSI Pharmaceuticals

Collaborators ^††

National Cancer Institute of Canada

Investigators ^†

Study Chair:

Frances Shepherd, M.D.

Information Provided By

OSI Pharmaceuticals

Verification Date

February 2003

First Received Date ^†

May 13, 2002

Last Updated Date

December 16, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.