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

This study has been completed.

First Received: May 13, 2002 Last Updated: December 16, 2005 History of Changes

Sponsor:	OSI Pharmaceuticals
Collaborator:	NCIC Clinical Trials Group
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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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:	No

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

Show 97 Study Locations

Sponsors and Collaborators

OSI Pharmaceuticals

NCIC Clinical Trials Group

Investigators

Study Chair:

Frances Shepherd, M.D.

More Information

No publications provided

Study ID Numbers:	OSI-774-BR.21
Study First Received:	May 13, 2002
Last Updated:	December 16, 2005
ClinicalTrials.gov Identifier:	NCT00036647 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:

Non-Small Cell Lung Cancer
Tarceva
EGFR
erlotinib

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009