Chemotherapy-treated recurrent non-small cell lung cancer
Conditions
Interventions
Sponsors
Department of Respirology/Division of Clinical Oncology, Graduate School of Medicine, Chiba University
Chiba Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with all of the following conditions; 1) Non-small cell lung cancer proven by histology and/or cytology 2) Recurrent non-small cell lung cancer already treated with 1 or 2 regimen, excluding post-operative adjuvant chemotherapy 3) Tissue sampling available for biomarker search/analysis 4) Age equal or older than 20-y at enrollment 5) No prior treatment with EGFR-TKIs 6) Able to be treated with PO medication 7) Measurable lesion by RECIST 8) PS of 0, 1 or 2 9) Able to be intensely monitored at least for 2 weeks 10) Adequate organ functions, evaluated within 2 weeks before enrollment, as; a) WBC >= 3,000/mm3 b) Netrophile >= 1,500/mm3 c) Hb >= 9.0 g/dL d) Plt >= 100,000/mm3 e) AST/ALT <= 100 IU/L f) T. Bil <= 1.5 g/dL g) Serum creatinine <= 1.5 mg/dL h) SpO2 >= 90% 11) Life expectancy of more than 3 months 12) Interval from previous treatment, of following, at enrollment; a) Equal or more than 3 weeks after completion of previous chemotherapy b) Equal or more than 4 weeks after completion of thoracic irradiation c) Equal or more than 1 week after completion of irradiation except for thoracic irradiation d) Equal or more than 2 weeks after surgical intervention including pleurodesis and pleural drainage 13) Witten informed consent from the patient
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 unable to be treated with PO drugs 5) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis 6) Pregnancy, breast feeding and suspected pregnancy 7) Symptomatic brain metastasis 8) Active synchronous malignancies 9) Uncontrolled diabetes mellitus 10) Other clinically significant complications 11) Other conditions inadequate for this research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate at week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, waterfall plot analysis, progression free survival time, overall survival time, safety, biomarker analysis, detection of EGFR mutation in blood sample | — |
Countries
Japan
Contacts
Public ContactTakiguchi, Yuichi
Graduate School of Medicine, Chiba University Department of Respirology/Division of Clinical Oncology
Outcome results
None listed