Phase II Study of First-Line Afatinib in Patients Aged 75 or Older With Advanced Lung Adenocarcinoma With EGFR Mutations
Phase 2
- Conditions
- Elderly patients with NSCLC harboring sensitive EGFR mutation
- Registration Number
- JPRN-UMIN000015834
- Lead Sponsor
- Osaka Lung Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
Not provided
Exclusion Criteria
1) Interstitial pneumonia/lung fibrosis on chest CT. 2) Previous drug allergy 3) History of poorly controlled pleural effusion, pericardial effusion and ascites. 4) Active infection. 5) Current Diarrhea. 6) Ileus or intestinal tract paralysis. 7) Symptomatic brain metastasis. 8) Active concomitant malignancy. 9) History of sever heart disease. 10) History of sever psychological disease. 11) Those judged to be not suitable by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS: progression free survival
- Secondary Outcome Measures
Name Time Method RR: response rate OS: overall survival DCR: disease control rate AE: Adverse events