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

NCT03262948 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2017-11-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • li zhang, doctor · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-10-01
Completion
2020-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262948 on ClinicalTrials.gov