Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903)
Phase 2
- Conditions
- Pre-treated non-small cell lung cancer with wild type EGFR and occurred in never or light smoker
- Registration Number
- JPRN-UMIN000002795
- Lead Sponsor
- orth East Japan Study Group /The Tokyo Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
Not provided
Exclusion Criteria
1)Presence of active interstitial pneumonia, radiation pneumonia, pneumoconiosis, or drug induced pneumonia 2)Uncontrolled pleural effusion, ascites, or pericardial effusion 3)Presence of infection that necessitates treatments with intravenous antibiotics 4)History of HER-related drug treatment 5)T790M mutation 6)Symptomatic eye disease 7)Pregnant patients 8)Symptomatic brain metastases 9)Other active malignancies 10)Poorly controlled diabetes mellitus 11)Severe and uncontrolled complication 12)Current smoker 13)Evaluated to be ineligible by a physician for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Disease control rate, progression free survival, overall survival, and safety. The biomarkers that predict the efficacy will be searched.