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

November 8, 2017 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

388

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Accepted the purpose of the trial, the contents , the predicted efficacy, pharmacological effects and the full explanation of the risk and was understood that the subject had signed the informed consent.
  • Subjects had histopathologically or cytologically confirmed NSCLC type of squamous cell carcinoma and were documented; (must be provided without radiotherapy, fixed with formalin, paraffin At least 5 sheets of tumor tissue after embedding)
  • Subjects were IIIB who were not suitable for radical surgery or radiotherapy, IV or recurrent NSCLC ; (according to the 7th edition of the International Lung Cancer Research Council (IASLC) classification)
  • Subjects who were palliative radiotherapy for bone lesions other than the chest were given the study drug according to CTCAE 4.03 toxicity ≤1
  • at least one measurable objective lesions according to RECIST1.1 standard
  • ECOG score ≤ 1
  • Expected survival time ≥ 3 months
  • Subjects are well-behaved, able to undergo treatment and follow-up, and voluntarily comply with this study
  • ≥ 18 years old male and female
  • The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative before 24 hours of the start of chemotherapy
  • Women must be non-lactating

Exclusion Criteria:

  • There is brain metastases;
  • The investigators believe that uncontrolled serious medical illnesses that affect the ability of subjects to receive research programs, such as severe medical illnesses, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Uncontrolled infections, active peptic ulcers;
  • Will hinder the understanding or make informed consent or fill in the questionnaire of dementia, mental state changes or any mental illness;
  • Any history of allergic or hypersensitivity to any treatment ingredient;
  • In the first 5 years of randomization, there were malignant tumors other than NSCLC, except for the treatment of basal cells or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ
  • Previously received treatment for advanced/metastatic NSCLC. Note: Allow chemotherapy and radiotherapy to be used as part of neoadjuvant/adjuvant therapy as long as the treatment has ended at least 12 months before the diagnosis of advanced or metastatic disease.
  • Received a taxane-based regimen as a neoadjuvant/adjuvant therapy for squamous cell carcinoma ;
  • Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
  • Physical examination and laboratory test results are abnormal ANC：<1.5×109 / L； PLT：<100×109/L； Hb: <90g/L
  • Abnormal liver function is defined as:

I) total bilirubin (TBil) level:> normal upper limit (ULN) 1.5 times; II) 2.5 times the rate of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> ULN, and> 5 times ULN if liver metastases are present

  • Definition of renal dysfunction:

Serum creatinine> ULN 1.5 times, or creatinine clearance <50ml/min

  • Coagulation function abnormal definition:

International Standardization Ratio (INR)> 1.5 times the ULN, and prothrombin time (PT) or activated partial coagulation Blood enzyme time (aPTT)> ULN 1.5 times, unless the subject is receiving anticoagulant therapy

  • Hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≥ 1×103copy number / L of the subjects; if HBsAg positive, and peripheral blood HBV-DNA <1 × 103 copy number / L, if the researchers believe that the subjects in a stable phase of chronic hepatitis B and does not increase the risk of subjects, the subjects eligible to be selected
  • Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive
  • need to merge other anti-tumor drug treatment
  • Received any other test drug treatment or participated in another interventional clinical trial before 30 days of screening period;
  • Researchers think it is not suitable for enrolling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nab-paclitaxel plus carboplatin
nab-paclitaxel 260mg/m2,i.v., plus carboplatin AUC = 6,i.v., 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.
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
Other Names:
  • keaili
Drug: Carboplatin
carboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel
Other Names:
  • bobei
Active Comparator: Paclitaxel plus carboplatin
paclitaxel 175 mg/m2,i.v., plus carboplatin AUC = 6,i.v., 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.
Drug: Carboplatin
carboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel
Other Names:
  • bobei
Drug: Paclitaxel
paclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel
Other Names:
  • aosu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall respond rate
Time Frame: overall respond rate will be evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.
the rate of CR and PR
overall respond rate will be evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
progression free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
os
Time Frame: From date of randomization until the date of death from any cause,assessed up to 18 months
overall survival
From date of randomization until the date of death from any cause,assessed up to 18 months
Quality of life assessment
Time Frame: It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.
evaluate the QOL according to Functional Assessment of Cancer Therapy-lung (FACT-L)
It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Principal Investigator: Li Zhang, Doctor, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 28, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NABP201706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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