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About
The Primary Objective is to evaluate the progression-free survival (PFS).
The secondary objectives are:
Full description
The study consists in:
Enrollment
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Volunteers
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
Adequate hepatic function
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
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.
Primary purpose
Allocation
Interventional model
Masking
375 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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