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
Goals The primary goal of this phase II trial is to: evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment Secondary goals are to: evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure
• Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
• Patients must be ≥ 18 years old of age
• ECOG performance status ≤ 1
• Estimated life expectancy of more than 3 months
• Treatment with only one prior chemotherapy
• At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• 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)
• Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
• Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)
• Provision of fully informed consent prior to any study specific procedures