adenocarcinoma of the lung
Conditions
Interventions
Afatinib40mg/day:oral daily
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with pulmonary adenocarcinoma with a histological diagnosis and cytodiagnosis. 2) Patients with EGFR gene mutation(exon 19 deletion mutation or L858R mutation in exon 21)within 1 year before enrollment. 3)Patients whose tumor specimen can be submitted. 4)Patients with pathologically confirmed diagnosis of stage IIIB(not amenable for curative intent local radiotherapy)/IV (recurrent or metastatic)adenocarcinoma of the lung. 5) Patients with no treatment of EGFR-TKI. 6) Patients that 2 wks pass from the last dosage of the anticancer drug in the case of systemic chemotherapy. 7) Patients with more than 20 years old on the enrollment day. 8) Patients with ECOG PS 0 or 1. 9) Patients harboring a more than one measurable lesion. 10) Patient whose latest level of laboratory test within 14 days before enrollment meets all following categories (the examination of the same date two weeks before the registration day is permitted). (1) Neutrophil >= 1,500/mm3 (2) Hemoglobin >= 9.0 g/dL(A blood transfusion is not enforced within 14 days of the examination before enrollment) (3) Platelet >= 10X104/ mm3 (4) Total bilirubin <= 1.5 mg/dl (5) AST(GOT)<= 100 (6) ALT(GPT)<= 100 (7) Serum creatinine <= 2.0 mg/dl (8) SpO2 >= 92%. In case of SpO2 < 92%, PaO2 >= 60 torr is eligible. 11) Patients providing written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with active double cancer 2)Patients with interstitial pneumonia confirmed by chest CT. 3)Patient with neurologic symptom caused by non-treated brain metastasis 4) Patients with either superior vena cava syndrome, pericardial effusion, pleural effusion or ascites >= Grade 3. 5) Patients with an operation with the systemic anesthesia within 28 days before enrollment. 6)Patient with a palliative radiotherapy for the metastatic focus except the chest (including gamma knife treatment for the brain metastatic focus) within 7 days before enrollment (the irradiation of the same day 2 weeks ago is permitted as enrollment day as day0). 7) Patient with a radiation exposure to the chest or mediastinum within 14 days before enrollment (the irradiation of the same day 2 weeks ago is permitted as enrollment day as day0). 8)Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study. 9) Patient with positive HBs antigen. 10) Patient having a serious infection to need systemic treatment. 11)Any other patients who are regarded as unsuitable for this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A detection of a biomarker about afatinib tolerance | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression Free Survival 2.Time to Systemic PD 3.Response rate 4.Safety | — |
Countries
Japan
Contacts
Public ContactEiji Iwama
Graduate School of Medical Sciences, Kyushu University Faculty of Medical Sciences, Department of Comprehensive Clinical Oncology
Outcome results
None listed