SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients
Status and phase
Completed
Phase 4
Conditions
Non Small Cell Lung Carcinoma
Treatments
Drug: Gefitinib
Details and patient eligibility
About
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.
Enrollment
156 patients
Sex
All
Ages
19 to 80 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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