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OpenTrials
Completed

NCT Number: NCT00608868

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

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.

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Key information

Conditions

Non Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Daegu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

Gefitinib tablet 250mg once daily orally

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: SELINE

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2008
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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