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Phase II study of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304)

Phase 2
Conditions
on-small cell lung cancer
Registration Number
JPRN-UMIN000011473
Lead Sponsor
OSAKA-LCSG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
23
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Problematic infection that requires anti-biotic, anti-fungal agent or anti-viral agent (2) Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest CT or with clinical symptoms (3) A history of severe hypersensitivity against erlotinib (4) Difficulty in oral administration of erlotinib, functional / organic impairment or inflammatory bowel disease that disturbs absorption of erlotinib (5) Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer (6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (7) Psychologically ineligible (8) Decision of ineligibility by a physician

Study & Design

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