Non-small cell lung cancer MedDRA version: 12.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically proven locally advanced or metastatic non-small cell lung cancer (stage IV, according to Tumor, Nodes, Metastasis (TNM) classification 7th edition) • Patients with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior chemotherapy, immunotherapy or targeted therapy for lung cancer disease (including adjuvant/neoadjuvant therapy) History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis History of another neoplasm. Adequately treated basal cell or squamous skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for >5 years are allowed Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization Acquired immunodeficiency syndrome (AIDS-related illness) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization Patient with reproductive potential (Male/Female) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of “effective method of contraception” will be based on the investigator’s judgment Inadequate organ function Pre-existing peripheral neuropathy > grade 1 according to the NCI CTCAE V.4.03 Pre-existing hearing impairment > grade 2 known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound of the study drug combination Other serious illness or medical conditions such as (but not restricted): Active infection, Superior vena cava syndrome, Pericardial effusion requiring intervention (drainage) Exclusion criteria related to ombrabulin Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third-degree atrioventricular block, stroke, or history of arterial or venous thrombo-embolism within the past 6 months still requiring anticoagulants. Uncontrolled hypertension within 3 months prior to study treatment or patient with organ damage related to hypertension. Patient with Left Ventricular Ejection Fraction (LVEF) value lower than institution inferior normal limit, evaluated by echocardiography orangiocardiography 12-lead Electrocardiogram (ECG): Infarction Q-wave, ST segment depression or elevation =1 mm in at least 2 contiguous leads
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane andplatinum, as first line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).;Secondary Objective: To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach.;Primary end point(s): Progression free survival (PFS) | — |
Countries
Germany, Italy
Outcome results
None listed