Clinical trial NCT01263886 (phase 2, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: ombrabulin (ave8062), placebo
SMILES: COC1=CC=C(\C=C/C2=CC(OC)=C(OC)C(OC)=C2)C=C1NC(=O)[C@@H](N)CO, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.