Elderly patients with NSCLC harboring sensitive EGFR mutation
Conditions
Interventions
Afatinib(30mg)/day p.o.
Sponsors
Osaka Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven lung adenocarcinoma. 2) Harboring mutations of EGFR. 3) Stage III, IV 4) Chemothrapy naive patients 5) Performance Status(ECOG Scale): 0-2. 6) Adequate organ function 7) Life expectancy more than 12 weeks. 8) Written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS: progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| RR: response rate OS: overall survival DCR: disease control rate AE: Adverse events | — |
Countries
Japan
Contacts
Public ContactNaruo Yoshimura
Graduate School of Medicine, Osaka City University Department of Respiratory Medicine
Outcome results
None listed