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Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer

Phase 2
Conditions
Chemotherapy-treated recurrent non-small cell lung cancer
Registration Number
JPRN-UMIN000002811
Lead Sponsor
Department of Respirology/Division of Clinical Oncology, Graduate School of Medicine, Chiba University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
46
Inclusion Criteria

Not provided

Exclusion Criteria

Patients with at least one of the following conditions are ineligible 1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage 2) Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 3) Patients with infection requiring iv administration of antibiotics and/or antifungal agents 4) Patients unable to be treated with PO drugs 5) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis 6) Pregnancy, breast feeding and suspected pregnancy 7) Symptomatic brain metastasis 8) Active synchronous malignancies 9) Uncontrolled diabetes mellitus 10) Other clinically significant complications 11) Other conditions inadequate for this research

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Disease control rate at week 8.
Secondary Outcome Measures
NameTimeMethod
Response rate, waterfall plot analysis, progression free survival time, overall survival time, safety, biomarker analysis, detection of EGFR mutation in blood sample
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