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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00608868

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 IV

MedlinePlus related topics: Cancer Lung Cancer Smoking

Drug Information available for: ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate Objective Response Rate of gefitinib as a second-line therapy for NSCLC patients based on RECIST and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor

Secondary Outcome Measures:

PFS (Progression-Free survivals), Assessment of symptom improvement and Quality of Life by FACT-L, Overall Survival

Enrollment:	156
Study Start Date:	January 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

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

Responsible Party:	Yeungnam University Hospital ( Prof. Kwan-Ho Lee )
Study ID Numbers:	D7913L00067
Study First Received:	January 23, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00608868
Health Authority:	South Korea: Institutional Review Board

Keywords provided by AstraZeneca:

Carcinoma
Non Small Cell Lung
EGFR mutation
Gefitinib

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Gefitinib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009