Phase 2 study of low-dose Afatinib maintenance therapy for patients with EGFR-mutated non-small-cell lung cancer
Phase 2
- Conditions
- EGFR-mutated non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000020688
- Lead Sponsor
- orth Japan Lung Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1. previously treated by EGFR-TKI 2. admitted EGFR gene mutation of T790M or exon20 insertion 3. symptomatic brain metastasis 4. with interstitial pneumonia or pulmonary fibrosis 5. with active other malignancies 6. with massive effusion required tube drainage 7. with active infection 8. with severe comorbidities 9. with other conditions that is considered inappropriate for the study by an attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year progressive free survival rate
- Secondary Outcome Measures
Name Time Method progresson free survival response rate incidence of adverse event incidence of adverse event of grade 3 or more