non-small cell lung cancer
Conditions
Interventions
Sponsors
Fukushima Medical University, cancer center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with StageIIIB or IV who pathologically proven non-small cell lung cancer. 2)Patients who have previously treated with one or two chemotherapy. 3)No prior treatment with EGFR-TKI(erlotinib,gefitinib,ZD6474,etc.). 4)Patients with EGFR mutation(Exon19,Exon21). 5)Possible cases with oral administration. 6)Patient who has at least one or more measurable lesion by RECIST. 7)Performance Status(ECOG)0-2 8)Patients who can be hospitalized for two weeks after beginning of the treatment or under management to apply to it. 9)Patients aged 20 years or older. 10)Sufficient function of main organ and bone marrow filled the following criteria. *Leukocyte counts >= 3,000/mm3 *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0 g/dl *AST and ALT, x 2 of upper limit of normal (ULN) or less. *Total bilirubin, 1.5mg/dl or less. *Serum creatinin, x 1.5 of ULN or less. *SpO2 90% or above. 12)interval: (1)chemotherapy, more than 4 weeks after the last chemotherapy. (2)Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs. (3)Operation, more than 4 weeks after the last operation (including pleurodesis) 13)Patients providing written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis. 2)Patients with massive pleural or pericardial effusion,or ascites. 3)Patients with active severe infections 4)Cases with past history of administration of HER related agents 5)Impossible cases with oral administration 6)Patients with active opthalmological disease 7)Patients with current or previous (within one year) history of gastrointestinal perforation 8)Patients with uncontrollable gastrointestinal ulceration 9)Pregnancy or lactation 10)Patients with symptomatic brain metastasis 11)Patients with active concomitant malignancy 12)Patients with uncontrollable diabetes mellitus 13)Patients with uncontrollable complications 14)Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| desease control rate, progression-free survival, overall survival, safety | — |
Countries
Japan
Contacts
Public ContactTakashi Ishida
Fukushima Medical University, School of Medicine Pulmonary Medicine
Outcome results
None listed