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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
Not Enrolling
Both
Carcinoma, Non-small-cell Lung

Thank you

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 WashingtonSeattle, Washington  98195
University of Chicago Medical CenterChicago, Illinois  60637