A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment
Inclusion Criteria:
1. Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung
histologically or cytologically
2. Patients must be ≥ 18 years old of age
3. ECOG performance status ≤ 1
4. Estimated life expectancy of more than 3 months
5. Treatment with only one prior chemotherapy
6. At least one lesion that can be measured by imaging (CT/MRI) according to the
Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
7. Adequate bone marrow function (absolute neutrophil count [ANC] ≥ 1,500/µL, hemoglobin
≥ 9.0 g/dL [correction by transfusion is acceptable], and platelets ≥ 100,000/µL)
8. Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
9. Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels
< 2.5xUNL)
10. Provision of fully informed consent prior to any study specific procedures
Exclusion Criteria:
1. Pregnant or breastfeeding women and women of childbearing potential not employing
adequate contraception
2. Patients who received prior chemotherapy including paclitaxel or docetaxel
3. Patients with second primary cancer (except, adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, or other solid tumors
curatively treated with no evidence of disease for ≥5 years)
4. Patients with defect of central nervous system (CNS) or any psychiatric disorders and
CNS metastases
5. Other serious illness or medical conditions A. Clinically significant cardiac disease
(uncontrolled congestive heart disease despite treatment [NYHA class III or IV],
symptomatic coronary artery disease, unstable angina or myocardial infarction,
conduction abnormality like grade 2 AV block, serious arrhythmia needed for
medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver
cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric
disorders including dementia or seizures D. Active uncontrolled infection E. Other
serious underlying medical conditions which could impair the ability of the patient
to participate in the study
6. Concomitant administration of any other experimental drug under investigation, or
concomitant chemotherapy, hormonal therapy, or immunotherapy