Squamous Cell Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)
Maintenance treatment of advanced stage squamous cell NSCLC.
Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive
care (BSC) or BSC alone as maintenance treatment after response or stable disease (SD) with
nab-paclitaxel plus carboplatin as induction in subjects with stage IIIB/IV squamous cell
NSCLC.
Subjects who discontinued treatment from the maintenance part for any reason other than
withdrawal of consent, lost to follow-up, or death, were entered into a Follow-up period that
had a visit 28 days after progression or discontinuation.
Those who entered Follow-up without progression continued with follow-up scans according to
standard of care (SOC) until documentation of progression of disease. Additionally, subjects
were followed for OS by phone approximately every 90 days for a minimum of 18 months, for up
to approximately 5 years after the last subject was randomized.
The sponsor used 15 Sep 2017 as the database cut-off date. ;