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

UMIN ID: C000000126

Registered date:07/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: gefitinib in patients with NSCLC
• Date of first enrollment: 2003/12/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): gefitinib 250mg/m2 EGFR orally per day

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None