Iressa 2nd Line Phase III Study in Japan

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Gefitinib or Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib or Docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the overall survival with these treatments as the primary outcome. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. |  |  |