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

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.

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.