SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.

Official Title
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A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients

Conditions
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Non Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological Diagnosis of local advanced/metastatic Non Small Cell Lung Carcinoma Previously failed the first-line chemotherapy Patient who can provide sample for EGFR mutation test Exclusion Criteria: Central Nervous System metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation Any evidence of clinically active interstitial lung disease

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|Gefitinib tablet 250mg once daily orally|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate(ORR) | Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated. According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of Progression-Free Survival | The median months without event of progression disease according to RECIST criteria is analysed. | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) | 
| Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L) | Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0 4 scale (0=not at all to 4=very much). A possible score was 0 28. The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L. The percentage of patients who showed improvement is reported. | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) | 
| Overall Survival |  | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death. | 
| Adverse Event | An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Non Small Cell Lung, EGFR mutation, Gefitinib