A Phase II Study of Weekly ABRAXANE® (Nab-paclitaxel) for Patients With Advanced NSCLC With EGFR Mutations Following Front-line Therapy With EGFR Tyrosine Kinase Inhibitors
I. To evaluate the overall response rate of weekly nab-paclitaxel (paclitaxel
albumin-stabilized nanoparticle formulation) in patients with advanced non-small cell lung
cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations following front-line
therapy with EGFR tyrosine kinase inhibitors (TKI).
I. To evaluate the safety profile of weekly nab-paclitaxel in patients with advanced NSCLC
with EGFR mutations following front-line therapy with an EGFR TKI.
II. To evaluate the time-to-progression and overall survival.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV)
over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks and then every 3
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete and partial response) defined by RECIST 1.1 criteria
The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.
Assessed up to 2 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|