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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00608868
First received: January 23, 2008
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Non Small Cell Lung Carcinoma
Drug: Gefitinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective Response Rate(ORR) [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ] [ Designated as safety issue: No ]

    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:
  • Period of Progression-Free Survival [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ] [ Designated as safety issue: No ]
    The median months without event of progression disease according to RECIST criteria is analysed.

  • 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) ] [ Designated as safety issue: No ]

    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.


  • 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. ] [ Designated as safety issue: No ]
  • Adverse Event [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 156
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gefitinib
    Gefitinib tablet 250mg once daily orally
  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608868

Locations
Korea, Republic of
Research Site
Daegu, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00608868     History of Changes
Other Study ID Numbers: D7913L00067
Study First Received: January 23, 2008
Results First Received: February 8, 2010
Last Updated: August 29, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by AstraZeneca:
Carcinoma
Non Small Cell Lung
EGFR mutation
Gefitinib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014