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.