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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00608868
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Carcinoma Drug: Gefitinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients
Study Start Date : January 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Intervention Details:
  • Drug: Gefitinib
    Gefitinib tablet 250mg once daily orally

Primary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]

    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 Outcome Measures :
  1. Period of Progression-Free Survival [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]
    The median months without event of progression disease according to RECIST criteria is analysed.

  2. Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]

    Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0~4 scale (0=not at all to 4=very much). A possible score was 0~28.

    The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L.

    The percentage of patients who showed improvement is reported.

  3. Overall Survival [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death. ]
  4. Adverse Event [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]
    An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00608868

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Korea, Republic of
Research Site
Daegu, Korea, Republic of
Sponsors and Collaborators

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Responsible Party: AstraZeneca Identifier: NCT00608868    
Other Study ID Numbers: D7913L00067
First Posted: February 6, 2008    Key Record Dates
Results First Posted: September 28, 2012
Last Update Posted: September 28, 2012
Last Verified: August 2012
Keywords provided by AstraZeneca:
Non Small Cell Lung
EGFR mutation
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action