Non-small Cell Lung Cancer Clinical Trial
Official title:
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
Primary Objective:
- To demonstrate progression free survival (PFS) improvement for ombrabulin compared to
placebo, in combination with taxane and platinum, as first line treatment for patients
with 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.
Patients will be treated for a maximum of 6 cycles (21 days each), in the absence of unacceptable toxicity or disease progression or consent withdrawal. All patients will be followed for disease progression documentation and for patient status until up to one year after the primary analysis cutoff date. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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