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

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ClinicalTrials.gov Identifier: NCT00036647
Recruitment Status : Completed
First Posted : May 14, 2002
Last Update Posted : June 16, 2015
Sponsor:
Collaborator:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small-cell Lung Drug: Tarceva (erlotinib HCl, OSI-774 ) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 731 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Study of OSI-774 (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
Study Start Date : October 2001
Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036647


  Show 97 Study Locations
Sponsors and Collaborators
OSI Pharmaceuticals
NCIC Clinical Trials Group
Investigators
Principal Investigator: Frances Shephard, M.D. Princess Margaret Hospital, Canada
More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00036647     History of Changes
Obsolete Identifiers: NCT00026325
Other Study ID Numbers: BR.21
First Posted: May 14, 2002    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by Astellas Pharma Inc:
Non-Small Cell Lung Cancer
Tarceva
EGFR
erlotinib

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action