Phase 4
Completed N=156
SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients
Source: ClinicalTrials.gov NCT00608868 ↗Enrolled (actual)
156
Serious AEs
16.2%
Results posted
Sep 2012
Primary outcomePrimary: Objective Response Rate(ORR) — 31.2 Percent of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate(ORR) |
31.2 | — |
| SECONDARY Period of Progression-Free Survival |
5.7 | — |
| SECONDARY Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L) |
41 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Adverse Event |
141 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00608868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.