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Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03262948
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact yumei wang, docter
Phone +86 0311-67808816
Email wyumei73@mail.ecspc.com
Status Not yet recruiting
Phase Phase 3
Start date December 1, 2017
Completion date October 1, 2020

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