Clinical trial NCT01038661 (phase 3, status: completed)
Conditions: lung neoplasms
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: docetaxel, cisplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
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.