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Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC

Phase 2
Recruiting
Conditions
on-small cell lung cancer
Registration Number
JPRN-UMIN000003539
Lead Sponsor
Yamaguchi Thoracic Oncology Group(YTOG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
26
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients with pulmonary disorders including idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia and drug-induced pneumonia (2) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome (3)Patients with complication with infectious disease which requires intravenous injection of antibiotic or antimycotic agent (4) Patients who have been treated with HER drugs (gefitinib, trastuzumab, lapatinib, cetuximab) (5) Patients who are not able to take oral medication (6) Patients with clinically significant ophthalmologic disorder (severe eye disorders including Sjogren's syndrome, keratoconjunctivitis sicca, keratitis) (7) Pregnant or lactating women (8) Brain metastasis with symptoms (9) Active multiple cancer (10) Diabetes patients with poor disease control (11) Patients with clinically significant complications (including cardiac disorder with poor control, severe arrhythmia requires medication, persistent watery diarrhea) (12) Patients who are considered ineligible based on decision of a responsible investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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