A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.
Phase 2
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 Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.
Inclusion Criteria:
- Failure of either first-line and/or second-line chemotherapy either of which was
platinum-based (the prior regimen must have failed the subject because of toxicity or
progression of tumor
- Prior histologic or cytologic confirmation of locally advanced or metastatic
(IIIB/IV) NSCLC
Exclusion Criteria:
- Subjects who have received second-line or subsequent chemotherapy
- Any evidence of clinically active interstitial lung disease (patients with chronic,
stable, radiographic changes who are asymptomatic, need not be excluded)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Primary Outcomes:
Principal Investigator
AstraZeneca Oncology Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
6474IL/0003
NCT ID:
NCT00059722
Start Date:
May 2003
Completion Date:
June 2007
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- NSCLC
- locally advanced or metastatic
- second-line
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
Name | Location |
|---|---|
| Research Site | Bentonville, Arkansas |
| Research Site | Anaheim, California |
| Research Site | Boca Raton, Florida |
| Research Site | Boise, Idaho |
| Research Site | Arlington Heights, Illinois |
| Research Site | Bloomington, Indiana |
| Research Site | Baton Rouge, Louisiana |
| Research Site | Branson, Missouri |
| Research Site | Albany, New York |
| Research Site | Asheville, North Carolina |
| Research Site | Bismarck, North Dakota |
| Research Site | Appleton, Wisconsin |
