A phase II, biomarker study using digital PCR method in EGFR mutated, advanced lung adenocarcinoma patients treated with afatinib. WJOG8114LTR
- Conditions
- EGFR mutated, advanced lung adenocarcinoma
- Registration Number
- JPRN-UMIN000015847
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 57
Not provided
1) Incapable of oral intake 2) With intestinal paralysis, or ileus 3) Chronic diarrhea 4)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT 5) Uncontrolled pleural / pericardial effusion, and ascites. 6) Symptomatic brain metastasis, or meningitis carcinomatosa. 7) Prior history of thoracic radiotherapy within 4 weeks 8) Prior surgery within 4 weeks 9) Active infection 10) Positive for HBs antigen 11) With severe complication 12) Concomitant cancers within 5 years 13) History of serious drug allergies 14) Patients requiring systemic steroid medication 15) With clinically problematic, psycho-neurologic diseases 16) Pregnancy, breast feeding, or hesitation in contraception 17) Other conditions not suitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concordance rate of EGFR mutation status between tumor tissue and serum.
- Secondary Outcome Measures
Name Time Method Clinical outcome; overall response rate, progression-free survival, and safety Biomarker analyses; EGFR mutation analysis using digital PCR method; 1. Tumor tissue and serum (before and after afatinib treatment), and 2. quantitative monitoring in serum Comprehensive analyses using next generation sequencing; tumor tissue and serum (before and after afatinib treatment) EGFR mutation (exon 19 deletion) analysis using blocking oligo dependent PCR method; tumor tissue and serum (before and after afatinib treatment)