Pre-treated non-small cell lung cancer with wild type EGFR and occurred in never or light smoker
Conditions
Interventions
Sponsors
Hiroshima citizens hospital Department of Medical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proved NSCLC 2) StageIIIB and IV disease or relapsed diseases after surgery that lack indication of surgery or radiotherapy 3) Patients who have previously treated 1 or 2 regimens of chemotherapy *Prior chemotherapy consisting of platinum agents in at least one regimen 4) Wild type EGFR 5) No previous EGFR-TKI treatment 6) Never or light smoker less than 10 pack year 7) possible to treat by the oral preparation 8) ECOG performance status of 0-2 9) Measureable region evaluable according to the RECIST 10) Expected to be observed for at least 2-4 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment 11) Elder than 20 years of age 12) Adequate organ functions 1.WBC -> 3,000 /mm3 2.Neutrophil ->1,500 /mm3 3.Platelet -> 100,000 /mm3 4.Hemoglobin concentration -> 9.0 g/dl 5.AST or ALT <- ULN x 2.5 6.Total bilirubin <- 1.5 mg/dl 7.Cr <- 1.5 mg/dl 8.SpO2 -> 95% 13) More than 4 weeks after last day of previous treatment 14) Written informed consent after the explanation of the content of the examination
Exclusion criteria
Exclusion criteria: 1) Radiotherapy to the primary site which is only possible to evaluate 2) superior vena cava syndrome 3) History of severe drug allergy 4) Uncontrolled pleural effusion, ascites, or pericardial effusion 5) History of active infection 6) Uncontrollable diarrhea 7) History of ileus 8) Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 9) Symptomatic eye disease 10) Current or previous(within the last 1 year) history of GI perforation 11) uncontrollable ulcer 12) Symptomatic brain metastases 13) Other active malignancies 14) History of active double cancer 15) Poorly controlled diabetes mellitus 16) History of severe heart disease 17) History of active psychological disease 18) History of pregnancy or lactation 19) Evaluated to be ineligible by a physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rat | — |
Countries
Japan
Outcome results
None listed