ABOUT THIS STUDY
1. Histologically or cytologically confirmed NSCLC: it is recommended to obtain adequate tissue samples for EGFR mutation analysis.
2. Unresectable stage IIIA (N2) or stage IIIB NSCLC defined as:unresectability confirmed by Surgeon /Stage IIIa T1-3 N2/Stage IIIb T1-4 N3/Stage IIIb T4 N2
3. Age 18 years over.
4. ECOG performance status of 0 or 1.
5. Tumor work-up: within 4 weeks prior 1st day of treatment: chest X-ray; CT of chest, liver, and adrenal glands; bone scan; brain MRI
6. Measurable or un-measurable disease (according to RECIST criteria), documented by CT, MRI, X-ray, or physical exam, as appropriate.
7. Hematology (within 1 week before 1st day of treatment)Absolute Neutrophil Count ³2.0 x 109/L; Platelet ³100 x 109/L; Hemoglobin ³10 g/dl
8. Liver function test (within 1 week before 1st day of treatment)Serum bilirubin £1 x UNL; AST & ALT £2.5 x UNL
9. Renal function (within 1 week before 1st day of treatment)Serum creatinine £1 x UNL. In case of borderline value, 24h creatinine clearance should be > 60 mL/min.
10. Pulmonary function (within 4 weeks before 1st day of treatment)FEV1 ³ 1 Liter
11. ECG without significant abnormalities within 4 weeks before 1st day of treatment.
12. Written informed consent.
1. T4 with malignant pleural effusion.
2. Any prior therapy (chemotherapy, immunotherapy, biologic therapy such as EGFR-targeted
therapy, radiotherapy) for lung cancer.
3. History of prior malignancies, except for cured non-melanoma skin cancer, curatively
treated in-situ carcinoma of the cervix or other cancer curatively treated and with no
evidence of disease for at least 5 years.
4. Unintended weight loss > 10% within the last 3 months.
5. Other serious concomitant illness or medical conditions:
6. Congestive heart failure or angina pectoris except if it is medically controlled.
Previous history of myocardial infarction within 1 year from study entry, uncontrolled
hypertension or arrhythmia.
7. History of significant neurological or psychiatric disorders including dementia or
8. Active infection requiring IV antibiotics.
9. Active ulcer, unstable diabetes mellitus or other contra-indication of corticosteroid
10. Significant gastrointestinal abnormalities, including requirement for intravenous
nutrition, active peptic ulcer disease, prior surgical procedures affecting
11. Pregnant or lactating women-Patients (male or female) with reproductive potential not
implementing adequate contraceptive measures.
12. Concurrent treatment with any other experimental anti-cancer drugs.
13. Concurrent use of phenytoin, carbamazepin, barbiturates, or rifampin.
14. Mental condition rendering the patient unable to understand the nature, scope, and
possible consequence of the study.
15. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to
return for follow-up visits, and not likely to complete the study.
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- Goyang-si, Gyenggi-do