Non small cell lung cancer with Epidermal Growth Factor Receptor mutation
Conditions
Interventions
Sponsors
Lung Oncology Group in Kyushu, Japan (LOGIK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer. 2) Patients who have previously treated one or two chemotherapy. 3) No previous treatment with EGFR-TKI 4) Patients having EGFR mutation (exon 19 deletion or L858R) 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 before two weeks from enrollment: *Leukocyte counts, 3,000/mm3 or over -12,000/mm3 or less. *Neutrophil counts, 1,500/mm3 or over -5000/mm3 or less. *Platelets, 100,000/mm3 or over. *Hemoglobin, 9.0g/dL or over. *AST and ALT, x 2 of upper limit of normal (ULN) or less. *Serum bilirubin, 1.5mg/dl or less. *Serum creatinin, x 1.5 of ULN or less. *SpO2 90% or above(room air). 11) Patients who are considered to survive for more than 3 months. 12) Interval (1)Chemotherapy: more than 4weeks after the last chemotherapy (2)Radiation: more than 12weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs (3)Operation: more than 4weeks after the last operation(including pleurodesis) 13)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. [ex) gefitinib, lapatinib, trsutuzumab, cetuximab] 5)Impossible cases with oral administration. 6)Patients with active opthalmological disease. 7) Patients with active concomitant malignancy. 8) Patients with symptomatic brain metastasis. 9)Patients with double cancer. 10)Patients with uncontrollabe diabetes mellitus. 11)Patients with uncontrollable complications. 12)Inappropriate patients for this study judged by the physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Contorol Rate,Safety,Progression Free Survival,Overall Survival | — |
Countries
Japan
Contacts
Public ContactKoichi Takayama
Kyushu University, Graduate School of Medical Sciences Research Institute for Diseases of the Chest
Outcome results
None listed