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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-small-cell Lung
Both
Carcinoma, Non-small-cell Lung
Trial Information
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
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
Frances Shephard, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
United States: Food and Drug Administration
Study ID:
BR.21
NCT ID:
NCT00036647
Start Date:
October 2001
Completion Date:
January 2003
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Non-Small Cell Lung Cancer
- Tarceva
- EGFR
- erlotinib
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Washington | Seattle, Washington 98195 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
