Effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence. -Phase II study
Phase 2
- Conditions
- EGFR mutated non-small cell lung cancer patients with postoperative recurrence
- Registration Number
- JPRN-UMIN000014443
- Lead Sponsor
- Gunma university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
Not provided
Exclusion Criteria
Patients were excluded 1)if they had interstitial pneumonia, pneumoconiosis, Radiation pneumonitis, drug-induced pneumonia. 2)Patient had already received EGFR-TKI 3)Patient had uncontrollable pleural effusion, ascites, pericardial effusion 4)Patient had uncontrolled concomitant diseases, baseline organ function. 5)Patients suspected of being pregnant or lactating women 6)Patients had brain tumors and/or brain metastases (symptomatic or requiring treatment) 7)Patients had additional significant malignancies diagnosed within the past 5 years 8)Tumour tissue had to T790M EGFR mutation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Over all survival Response rate Safety