Phase II study of erlotinib monotherapy for patients with advanced stage of non-small cell lung cancer, undetectable epidermal growth factor receptor (EGFR) mutations by PNA LNA PCR clamp method, but positive immuno-staining with anti-EGFR mutation-specific antibodies.
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000014299
- Lead Sponsor
- Dept. of Respiratory Medicine, Osaka Police Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 7
Not provided
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
Name Time Method Progression Free Survival(PFS)
- Secondary Outcome Measures
Name Time Method Response Rate(RR), 1-year survival rate, Overall Survival(OS), Time to treatment failure:TTF, Toxicities