Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer (DISRUPT)

This is an interventional treatment trial for Non-small Cell Lung Cancer Read More

Inclusion criteria:

• Histologically proven squamous metastatic non-small cell lung cancer (stage IV, according to Tumor Nodes Metastasis (TNM) classification seventh 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

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 National Cancer Institute Common Terminology Criteria for Adverse Events (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)
• 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 thromboembolism 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 or angiocardiography
• 12-lead Electrocardiogram (ECG): Infarction Q-wave, ST segment depression or elevation ≥1 mm in at least 2 contiguous leads
• History of gross hemoptysis (i.e. 1/2 teaspoon of red blood or more per episode) within the past 1 month.
• Has non-squamous NSCLC(adenocarcinoma/large cell or other)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.