Phase II study of gefitinib therapy inserted by chemotherapy as first line treatment for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutatio
- Conditions
- on-small-cell lung cancer
- Registration Number
- JPRN-UMIN000001738
- Lead Sponsor
- Thoracic Medical Oncology, National Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Not provided
1) EGFR mutation that associates with gefitinib resistance (exon 20 T790M) or K-ras mutation 2) CNS metastasis requiring treatment 3) Interstitial pneumonitis or pulmonary fibrosis as determined from chest CT 4) Complications like below a) Active infection b) Acute myocardial infarction, the other severe heart diseases, and arrhythmia within the previous 6months c) Uncontrollable diabetes mellitus d) Uncontrollable hypertension e) Continuous diarrhea and ileus f) Psychological disorders difficult to cooperate in the clinical trial 5) Receiving systemic corticosteroid therapy 6) Active metachronous cancer (disease-free survival of less than 5years) 7) Pregnancy or breast-feeding 8) No intent to practice contraception 9) Difficult to take medicine continuously
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method