Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy

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 \<= UNL or creatinine clearance \>= 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.