NCT03262948

Nab-Paclitaxel Versus Paclitaxel Plus Carboplatin in Advanced Squamous Cell Non Small Cell Lung Cancer

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	nab-paclitaxel	albumin-bound paclitaxel is 260 mg/m2 intravenously over 30 minutes on Days 1 of each 21-day cycle cycle immediately after albumin-bound paclitaxel
DRUG	Paclitaxel	paclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel
DRUG	Carboplatin	carboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-10-01
• Completion: 2020-10-01
• First posted: 2017-08-28
• Last updated: 2017-11-13