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This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: May 2, 2003
Last updated: August 22, 2016
Last verified: August 2016
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: ZD6474
Drug: Placebo
Drug: ZD1839
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Primary Outcomes:
  • Part A
  • i. Time to progression
  • ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes
  • Part B

Secondary Outcome Measures:
  • Secondary Outcomes:
  • Part A
  • i. Objective response
  • ii. Disease control at 8 weeks
  • iii. Time to death
  • iv. WHO performance status
  • v. QOL and LCS from the FACT-L questionnaire
  • Part B
  • i. Objective response in subjects following treatment with the alternate study treatment
  • ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
  • iii. WHO performance status in subjects following treatment with the alternate study treatment
  • iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment

Estimated Enrollment: 160
Study Start Date: May 2003
Study Completion Date: June 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00059722

  Show 46 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00059722     History of Changes
Obsolete Identifiers: NCT00072423
Other Study ID Numbers: 6474IL/0003
Study First Received: May 2, 2003
Last Updated: August 22, 2016

Keywords provided by Sanofi:
locally advanced or metastatic

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017