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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib

Criteria

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