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

Non Small Cell Lung Carcinoma Clinical Trial

— SELINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608868
• Other study ID #: D7913L00067
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2008
• Last updated: August 29, 2012
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Intervention

Drug:
• Gefitinib
Gefitinib tablet 250mg once daily orally

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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.	No
Secondary	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)	Yes