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A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutatio

Phase 2
Conditions
on-small cell lung cancer
Registration Number
JPRN-UMIN000002716
Lead Sponsor
Central Japan Lung Study Group (CJLSG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
29
Inclusion Criteria

Not provided

Exclusion Criteria

1) Active infection or other serious disease condition (poorly controlled diabetes mellitus,cardiac disease, Unstable angina, Cardiac infarction, Psychological illness, etc.). 2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome. 4) Symptomatic brain metastasis. 5) Severe drug allergy. 6) Previous radiotherapy to primary lung cancer. 7) Patients who have previously treated three or more chemotherapy. 8) Patients who had a relapse after surgery. 9) With active double cancer. 10) Pregnancy or lactation. 11) Severe disorder of the eye. 12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
rseponse rate
Secondary Outcome Measures
NameTimeMethod
Disease control rate, Progression free survival, overall survival, Median survival time, 1-year survival rate, Evaluation of safety
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