tax first-line chemotherapy with different doses and then maintenance therapy

Conditions: Lung Neoplasms

Summary: the primary objective is to evaluate the progression-free survival (pfs). the secondary objectives are: * to compare the disease control rates of different doses of docetaxel+cisplatin as first-line treatment according to response evaluation criteria in solid tumors (recist) criteria; * to evaluate the overall response rate (orr); * to evaluate the time to disease progression (ttp); * to evaluate the overall survival (os); * to evaluate the toxicity.

the study consists in: * a first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) , * a maintenance treatment phase: participants with disease control (complete response \[cr\], partial response \[pr\] or stable disease \[sd\]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (bsc). * a follow-up period from the end of study treatment until participant death or end of study.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of advanced non-small-cell lung cancer (nsclc) * based on international association for the study of lung cancer (iaslc) 2009 new tumor-node-metastasis (tnm) stage criteria of lung cancer, local advanced stage iiib (not applicable for radical radiation therapy) disease or metastatic stage iv disease or recurrent disease * at least one evaluable tumor lesion based on recist criteria (\>= 20 mm with conventional techniques or \>= 10 mm with spiral computed tomography scan) * eastern cooperative oncology group performance status (ecog ps) 0/1 * adequate bone marrow reserve * absolute neutrophil count \>= 2.0×10\^9/l * platelets \>= 100×10\^9/l * hemoglobin \>= 9.0 g/dl * adequate hepatic function * total bilirubin \<= upper normal limit (unl) * aspartate amino transferase (ast), alanine amino transferase (alt) \<= 2.5 unl * alkaline phosphatase (alp) \<= 5 unl * adequate renal function (serum creatinine \ = 60 ml/min) * no prior chemotherapy was allowed or only (neo) adjuvant chemotherapy ended more than 6 months before treatment (patients should not have been heavily pre-treated, the maximum cumulative dose of cisplatin allowed is 350 mg/m²) * prior surgery was permitted only if the operation performed more than 4 weeks ago and the patient was completely recovery * childbearing potential either terminated or attenuated by the use of an approved contraceptive method * inform consent signed exclusion criteria: * other tumour type than advanced / metastatic nsclc in recent 5 years (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin). * presence of symptomatic central nervous system metastases * inadequate liver function * total bilirubin \> 1 unl * alt and/or ast\>1.5 unl associated with alkaline phosphatase \> 2.5 unl * inadequate renal function (creatinine \> 1.0 times unl and in case of limit value, creatinine clearance \< 60 ml/min) * prior radiation therapy, or surgery operation within 4 weeks * prior use of taxoids * active infection, or serious concomitant systemic disorder incompatible with the study * childbearing potential but unwilling to use of an approved contraceptive method * receive treatment from other clinical trials during this study treatment * history of hypersensitivity to any of study medication * other serious concomitant abnormal or illness the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.