Non-small cell lung cancer
Conditions
Interventions
Sponsors
Shizuoka General Hospital Respiratory center
Shizuoka Cancer Center Division of Thoracic Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Non-small cell lung cancer proven by histology and/or cytology 2)Recurrent non-small cell lung cancer already treated with at least one regimens of chemotherapy 3)Patients having EGFR mutation (exon 19 deletion or L858R) 4)No prior treatment with EGFR-TKIs 5)Patients who have at least one measurable lesion, one must be brain lesion, by RECIST. In the case Stereotactic irradiation such as gammma knives is eligible, those treatment can be priority. After those treatmen, patients are eligible if the measurable brain lesion still remain. 6)Performance status(ECOG):0-3 7)Able to be intensely monitored at least for 2 weeks 8)Patients aged 20 years or older 9)Adequate organ functions, evaluated within 2 weeks before enrollment, as; a) WBC >= 3,000/mm3 b) Netrophile >= 1,500/mm3 c) Plt >= 100,000/mm3 d) AST/ALT, x 2 of upper limit of normal or less. e) T. Bil <= 1.5 g/dL f) Serum creatinine, x 1.5 of upper limit of normal or less. g) SpO2 >= 90% as room air 10)Patients are excepted to live over 8 weeks. 11)Written informed consent is required to obtain from each patients at each participating institution
Exclusion criteria
Exclusion criteria: Patients with at least one of the following conditions are ineligible 1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage 2)Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 3)Patients with infection requiring iv administration of antibiotics and/or antifungal agents 4)Patients who has received HER modulator medicine in the past 5)Patients unable to be treated with PO drugs 6) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis 7)Pregnant or breast feeding 8) Active synchronous malignancies 9) Uncontrolled diabetes mellitus 10)Other clinically significant complications 11)Patients judged as being in inappropriate condition for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy for brain metastasis, Disease Control Rate, Progression Free Survival, Overall Survival, Evaluation of safety | — |
Countries
Japan
Contacts
Public ContactYuichirou Shishido
Shizuoka General Hospital Respiratory medicine
Outcome results
None listed