Clinical trial · Interventional
SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients
A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients
NCT00608868CI-TRIAL-00008167SELINEcompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Response Rate(ORR)
- timeFrame
- Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
- description
- 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.
Secondary outcomes (4)
- measure
- Period of Progression-Free Survival
- timeFrame
- Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
- description
- The median months without event of progression disease according to RECIST criteria is analysed.
- measure
- Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.