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

• ClinicalTrials.gov Identifier: NCT00608868
• Recruitment Status: Completed
• First Posted: February 6, 2008
• Results First Posted: September 28, 2012
• Last Update Posted: September 28, 2012
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

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

Study Design

• 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

Arms and Interventions

Intervention Details:

• Drug: Gefitinib
  Gefitinib tablet 250mg once daily orally

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Korea, Republic of

Research Site

Daegu, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00608868
• Other Study ID Numbers: D7913L00067
• First Posted: February 6, 2008
• Results First Posted: September 28, 2012
• Last Update Posted: September 28, 2012
• Last Verified: August 2012

Keywords provided by AstraZeneca:

Carcinoma; Non Small Cell Lung; EGFR mutation; Gefitinib

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Gefitinib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action