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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
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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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 SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteBaton Rouge, Louisiana  
Research SiteBranson, Missouri  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteAppleton, Wisconsin