Trial Information
A Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens
Inclusion Criteria:
- You are "histologically" or "cytologically" confirmed to have recurrent or metastatic
NSCLC
- You have been treated with chemotherapy including platinums for NSCLC.
Exclusion Criteria:
- You have received treatment for non-small lung cancer within 4 weeks before your
participation in this study (except for specific therapies)
- You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis,
pulmonary pneumonia, or pneumoconiosis evident on the X-ray
- You have or had any disease of radiation pneumonia or drug-induced pneumonia, which
requires treatment with corticosteroids
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the overall survival with these treatments as the primary outcome.
Principal Investigator
AstraZeneca Japan Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D791AL00001
NCT ID:
NCT00252707
Start Date:
September 2003
Completion Date:
November 2006
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms