Iressa 2nd Line Phase III Study in Japan

Phase 3

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00252707
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Study Completion: 2006-11
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-14
• Last Update Posted: 2007-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determine the overall survival with these treatments as the primary outcome.

Secondary Outcome Measures

Name	Time	Method
- Time to treatment failure (TTF)
Determine the followings as the secondary outcome variables:
- Progression-free survival (PFS)
- 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 expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
- 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.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamagata, Japan