A Multinational, Randomized, Double Blind, Controlled Phase II Trial of Ombrabulin With Taxane and Platinum Combination Administered Every Three Weeks, in First Line Treatment of Patients Metastatic Non-small Cell Lung Cancer

Inclusion 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.