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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Carcinoma

Keywords

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Carcinoma Non Small Cell Lung EGFR mutation Gefitinib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib

Gefitinib tablet 250mg once daily orally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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D7913L00067

Identifier Type: -

Identifier Source: org_study_id