Non-small Cell Lung Cancer Clinical Trial
Official title:
The Randomized,Open, Multicenter Phase III Study to Compare the Effectiveness and Safety of Nab-Paclitaxel Versus Paclitaxel Plus Carboplatin First-Line Therapy Advanced Non Small Cell Lung Cancer Squamous Cell Carcinoma
This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by sex, ECOG physical status, smoking status, disease staging.
Subjects will receive one of two treatment regimens:
Group A: intravenous infusion of paclitaxel (albumin binding) 260 mg/m2, intravenous
infusion, carboplatin area under curve (AUC) = 6, intravenous infusion, starting from
randomization, once every 3 weeks, for 4-6 cycles,or progression, or intolerance, or deth or
start a new anti-tumor treatment, whichever occurs first.
Group B: paclitaxel injection 175 mg/m2, intravenous infusion, carboplatin AUC= 6,
intravenous infusion, starting from randomization, once every 3 weeks, for 4-6 cycles, or
progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs
first.The primary end point is overall response rate (ORR),the secondary endpoint is
progression-free survival (PFS), overall survival (OS), safety and Quality of Life (QOL).
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