Phase II study of low-dose afatinib for elderly NSCLC patients
Phase 2
- Conditions
- on-small cell lung cancerLung Cancer
- Registration Number
- JPRN-jRCTs041180055
- Lead Sponsor
- Takahashi Toshiaki
- Brief Summary
This study results suggested the efficacies and safety of afatinib at a dose of 20 mg for elderly patients with non-small cell lung cancer harboring EGFR mutations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
1) Pathologically confirmation of non-small cell lung cancer
2) Clinical stage IIIB, IV, or postoperative recurrence
3) With activating EGFR mutation (Deletion in exon 19 or L858R in exon 21)
4) ECOG performance status 0-2
5) No prior therapy of EGFR-TKI
6) Measurable lesions based on RECIST ver1.1
7) Adequate organ functions
8) Written informed consent
Exclusion Criteria
1) Interstitial lung disease
2) Receiving continuous systemic corticosteroid
3) During pregnancy or lactation
4) Psychological disorder difficult to participate in this clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method