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

NCT00608868 | Completed Phase 4 Results

• 1 other identifier: D7913L00067
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Carcinoma

Keywords

Carcinoma; Non Small Cell Lung; EGFR mutation; Gefitinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Period of Progression-Free Survival

  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)

  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

  Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)

Interventions

Gefitinib DRUG

Gefitinib tablet 250mg once daily orally

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Daegu, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Hui Jung Sin
• Organization: Medical, Astrazeneca Korea

huijung.sin@astrazeneca.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 28, 2012
• Results First Posted: September 28, 2012

Record last verified: 2012-08

Locations

KR (1)