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

Phase 4

Completed

• Conditions: Non Small Cell Lung Carcinoma

• Registration Number: NCT00608868
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-06
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2010-02-08
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-29
• Last Update Submitted: 2012-08-29
• Results First Posted: 2012-09-28
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR)	Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)	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.

Secondary Outcome Measures

Name	Time	Method
Period of Progression-Free Survival	Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)	The median months without event of progression disease according to RECIST criteria is analysed.
Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)	Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)	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.
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	Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)	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.

Trial Locations

Locations (1)

Research Site; 🇰🇷 Daegu, Korea, Republic of