non-small cell lung cancer
Conditions
Interventions
Sponsors
Yamaguchi Thoracic Oncology Group(YTOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically proven non-small cell lung cancer. (2) Patients with recurrent non-small cell lung cancer of stage IIIB or IV after surgery who did not respond to or relapsed after prior >=2 chemothrepies. (3) Non-smoker*1 or light smoker*2 (4) Age >=20 years (at the time of registration) (5) No prior treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) (6) Patient who has at least one or more measurable lesion by RECIST (7) ECOG performance status (PS): 2-3 (8) Patients who are able to receive treatment by hospitalization for at least 2 weeks or under equivalent condition (9) Sufficient function of main organs and bone marrow filled the following criteria. - Leukocyte count >=3000/mm3 - Neutrophil count >=1500/mm3 - Hemoglobin >=8.0g/dL - Platelet >=100,000/mm3 - AST and ALT <=100 IU/L - Total bilirubin <=1.5mg/dL - Serum creatinine <=1.5mg/dL - Sp O2 >=90% (10) Patients who are considered to survive for more than 2 months (11) Time from the previous treatment at the time of day 1 of the study treatment: Chemotherapy - >=3 weeks from the last treatment Radiation therapy - Irradiation to chest: >=12 weeks from the last irradiation - Irradiation to other lesion: >=2 weeks from the last irradiation Surgery and treatment (pleural adhesion surgery and pleural drainage) - >=2 weeks from the surgery/last treatment (12) Patient who signed a written informed consent *1 Non-smoker: <=100 cigarettes in lifetime *2 Light smoker: Non-smoker for >=15 years and10 packs/year
Exclusion criteria
Exclusion criteria: (1) Patients with pulmonary disorders including idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia and drug-induced pneumonia (2) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome (3)Patients with complication with infectious disease which requires intravenous injection of antibiotic or antimycotic agent (4) Patients who have been treated with HER drugs (gefitinib, trastuzumab, lapatinib, cetuximab) (5) Patients who are not able to take oral medication (6) Patients with clinically significant ophthalmologic disorder (severe eye disorders including Sjogren's syndrome, keratoconjunctivitis sicca, keratitis) (7) Pregnant or lactating women (8) Brain metastasis with symptoms (9) Active multiple cancer (10) Diabetes patients with poor disease control (11) Patients with clinically significant complications (including cardiac disorder with poor control, severe arrhythmia requires medication, persistent watery diarrhea) (12) Patients who are considered ineligible based on decision of a responsible investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rseponse rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, progression free survival, overall survival, improvement of PS, safety profile | — |
Countries
Japan
Contacts
Public ContactYoshihiko Segawa
National Hospital Organization,Yamaguchi - Ube Medical Center Department of Respiratory Medicine
Outcome results
None listed