NCT00252707CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 484
- Locations
- 40
- Primary Endpoint
- Determine the overall survival with these treatments as the primary outcome.
Study Overview
Brief Summary
In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Determine the overall survival with these treatments as the primary outcome.
Secondary Outcomes
- - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
- Determine the followings as the secondary outcome variables:
- - Progression-free survival (PFS)
- - Time to treatment failure (TTF)
- - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
- - Lung cancer subscale (LCS)
- - QOL according to FACT-L questionnaire
- - Frequency and severity of adverse events.
- Determine the followings as the exploratory outcome variables:
- - Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells.
Investigators
Study Sites (40)
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