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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


Phase 3
20 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

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

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