NIPH Clinical Trials Search

UMIN ID: C000000126

Registered date:07/09/2005

Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedgefitinib in patients with NSCLC
Date of first enrollment2003/12/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)gefitinib 250mg/m2 EGFR orally per day


Primary OutcomeRelationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and efficacy of gefitinib
Secondary OutcomeRelationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and disease control rate or safety of gefitinib

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Gefitinib with concurrently other chemotherapy 2) Need of curable radiation therapy to primary lesion. 3) Need of radiation therapy to the biopsy lesion for tissue samples for immunohistochemical analyses 4) Old tissue sample (before 2 regimens from the gefitinib therapy) for immunohistochemical analyses and no way to gain a new tissue sample 5) No estimation of at least 3 months survival 6) Intestinal pneumonia or lung fibrosis 7) History of severe drug allergic reaction 8) Severe infection and complication (cardio insufficiency or hemorrhage etc.) 9) Severe diarrhea 10) Bowel obstruction 11) Symptomatic brain metastasis 12) History of other malignancy 13) Pregnant women or women willing child-bearing 14) No regulatory condition because of psychological disease 15) Inadequate condition diagnosed by primary physician

Related Information


public contact
Name Shinichiro Nakamura
Address Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Kenji Tamura MD
Address Otoda, Ikoma, Nara, 630-0293, Japan Japan
Telephone 0743-77-0880
Affiliation Kinki University School of Medicine, Nara Hospital Department of Medical Oncology