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

Phase 2

• Conditions: gefitinib in patients with NSCLC

• Registration Number: JPRN-C000000126
• Lead Sponsor: West Japan Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-07
• Study Completion: 2007-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and efficacy of gefitinib

Secondary Outcome Measures

Name	Time	Method
Relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and disease control rate or safety of gefitinib