<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262948</url>
  </required_header>
  <id_info>
    <org_study_id>NABP201706</org_study_id>
    <nct_id>NCT03262948</nct_id>
  </id_info>
  <brief_title>Nab-Paclitaxel Versus Paclitaxel Plus Carboplatin in Advanced Squamous Cell Non Small Cell Lung Cancer</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage&#xD;
      IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent&#xD;
      squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to&#xD;
      one of the two treatment groups at a 1: 1 ratio, and stratified by sex, ECOG physical status,&#xD;
      smoking status, disease staging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will receive one of two treatment regimens:&#xD;
&#xD;
      Group A: intravenous infusion of paclitaxel (albumin binding) 260 mg/m2, intravenous&#xD;
      infusion, carboplatin area under curve （AUC) = 6, intravenous infusion, starting from&#xD;
      randomization, once every 3 weeks, for 4-6 cycles,or progression, or intolerance, or deth or&#xD;
      start a new anti-tumor treatment, whichever occurs first.&#xD;
&#xD;
      Group B: paclitaxel injection 175 mg/m2, intravenous infusion, carboplatin AUC= 6,&#xD;
      intravenous infusion, starting from randomization, once every 3 weeks, for 4-6 cycles, or&#xD;
      progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs&#xD;
      first.The primary end point is overall response rate (ORR),the secondary endpoint is&#xD;
      progression-free survival (PFS), overall survival (OS), safety and Quality of Life (QOL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>overall respond rate</measure>
    <time_frame>overall respond rate will be evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.</time_frame>
    <description>the rate of CR and PR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <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</time_frame>
    <description>progression free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>os</measure>
    <time_frame>From date of randomization until the date of death from any cause,assessed up to 18 months</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <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.</time_frame>
    <description>evaluate the QOL according to Functional Assessment of Cancer Therapy-lung (FACT-L)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">388</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>nab-paclitaxel plus carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel plus carboplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nab-paclitaxel</intervention_name>
    <description>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</description>
    <arm_group_label>nab-paclitaxel plus carboplatin</arm_group_label>
    <other_name>keaili</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>paclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel</description>
    <arm_group_label>Paclitaxel plus carboplatin</arm_group_label>
    <other_name>aosu</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>carboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel</description>
    <arm_group_label>Paclitaxel plus carboplatin</arm_group_label>
    <arm_group_label>nab-paclitaxel plus carboplatin</arm_group_label>
    <other_name>bobei</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Accepted the purpose of the trial, the contents , the predicted efficacy,&#xD;
             pharmacological effects and the full explanation of the risk and was understood that&#xD;
             the subject had signed the informed consent.&#xD;
&#xD;
          -  Subjects had histopathologically or cytologically confirmed NSCLC type of squamous&#xD;
             cell carcinoma and were documented; (must be provided without radiotherapy, fixed with&#xD;
             formalin, paraffin At least 5 sheets of tumor tissue after embedding)&#xD;
&#xD;
          -  Subjects were IIIB who were not suitable for radical surgery or radiotherapy, IV or&#xD;
             recurrent NSCLC ; (according to the 7th edition of the International Lung Cancer&#xD;
             Research Council (IASLC) classification)&#xD;
&#xD;
          -  Subjects who were palliative radiotherapy for bone lesions other than the chest were&#xD;
             given the study drug according to CTCAE 4.03 toxicity ≤1&#xD;
&#xD;
          -  at least one measurable objective lesions according to RECIST1.1 standard&#xD;
&#xD;
          -  ECOG score ≤ 1&#xD;
&#xD;
          -  Expected survival time ≥ 3 months&#xD;
&#xD;
          -  Subjects are well-behaved, able to undergo treatment and follow-up, and voluntarily&#xD;
             comply with this study&#xD;
&#xD;
          -  ≥ 18 years old male and female&#xD;
&#xD;
          -  The childbearing age subjects must agree to take effective contraceptive measures&#xD;
             during the trial; the serum or urine pregnancy test must be negative before 24 hours&#xD;
             of the start of chemotherapy&#xD;
&#xD;
          -  Women must be non-lactating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There is brain metastases;&#xD;
&#xD;
          -  The investigators believe that uncontrolled serious medical illnesses that affect the&#xD;
             ability of subjects to receive research programs, such as severe medical illnesses,&#xD;
             including severe heart disease, cerebrovascular disease, uncontrolled diabetes,&#xD;
             uncontrolled high blood pressure, Uncontrolled infections, active peptic ulcers;&#xD;
&#xD;
          -  Will hinder the understanding or make informed consent or fill in the questionnaire of&#xD;
             dementia, mental state changes or any mental illness;&#xD;
&#xD;
          -  Any history of allergic or hypersensitivity to any treatment ingredient;&#xD;
&#xD;
          -  In the first 5 years of randomization, there were malignant tumors other than NSCLC,&#xD;
             except for the treatment of basal cells or squamous cell skin cancer, localized&#xD;
             prostate cancer after radical resection, and ductal carcinoma in situ&#xD;
&#xD;
          -  Previously received treatment for advanced/metastatic NSCLC. Note: Allow chemotherapy&#xD;
             and radiotherapy to be used as part of neoadjuvant/adjuvant therapy as long as the&#xD;
             treatment has ended at least 12 months before the diagnosis of advanced or metastatic&#xD;
             disease.&#xD;
&#xD;
          -  Received a taxane-based regimen as a neoadjuvant/adjuvant therapy for squamous cell&#xD;
             carcinoma ;&#xD;
&#xD;
          -  Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;&#xD;
&#xD;
          -  Physical examination and laboratory test results are abnormal ANC：&lt;1.5×109 / L；&#xD;
             PLT：&lt;100×109/L； Hb: &lt;90g/L&#xD;
&#xD;
          -  Abnormal liver function is defined as:&#xD;
&#xD;
        I) total bilirubin (TBil) level:&gt; normal upper limit (ULN) 1.5 times; II) 2.5 times the&#xD;
        rate of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)&gt; ULN, and&gt; 5&#xD;
        times ULN if liver metastases are present&#xD;
&#xD;
          -  Definition of renal dysfunction:&#xD;
&#xD;
        Serum creatinine&gt; ULN 1.5 times, or creatinine clearance &lt;50ml/min&#xD;
&#xD;
          -  Coagulation function abnormal definition:&#xD;
&#xD;
        International Standardization Ratio (INR)&gt; 1.5 times the ULN, and prothrombin time (PT) or&#xD;
        activated partial coagulation Blood enzyme time (aPTT)&gt; ULN 1.5 times, unless the subject&#xD;
        is receiving anticoagulant therapy&#xD;
&#xD;
          -  Hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus&#xD;
             DNA (HBV-DNA) titer ≥ 1×103copy number / L of the subjects; if HBsAg positive, and&#xD;
             peripheral blood HBV-DNA &lt;1 × 103 copy number / L, if the researchers believe that the&#xD;
             subjects in a stable phase of chronic hepatitis B and does not increase the risk of&#xD;
             subjects, the subjects eligible to be selected&#xD;
&#xD;
          -  Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV)&#xD;
             antibody positive&#xD;
&#xD;
          -  need to merge other anti-tumor drug treatment&#xD;
&#xD;
          -  Received any other test drug treatment or participated in another interventional&#xD;
             clinical trial before 30 days of screening period;&#xD;
&#xD;
          -  Researchers think it is not suitable for enrolling.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>li zhang, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>yumei wang, docter</last_name>
    <phone>+86 0311-67808816</phone>
    <email>wyumei73@mail.ecspc.com</email>
  </overall_contact>
  <results_reference>
    <citation>Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.</citation>
    <PMID>22547591</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>November 8, 2017</last_update_submitted>
  <last_update_submitted_qc>November 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262948
org study id: NABP201706
nct id: NCT03262948
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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.
description: the rate of CR and PR
measure: 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
description: progression free survival
measure: os
time frame: From date of randomization until the date of death from any cause,assessed up to 18 months
description: overall survival
measure: 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.
description: evaluate the QOL according to Functional Assessment of Cancer Therapy-lung (FACT-L)
arm group label: nab-paclitaxel plus carboplatin
arm group type: Experimental
description: 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.
arm group label: Paclitaxel plus carboplatin
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: nab-paclitaxel
description: 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
arm group label: nab-paclitaxel plus carboplatin
other name: keaili
intervention type: Drug
intervention name: Paclitaxel
description: paclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel
arm group label: Paclitaxel plus carboplatin
other name: aosu
intervention type: Drug
intervention name: Carboplatin
description: carboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel
arm group label: Paclitaxel plus carboplatin
arm group label: nab-paclitaxel plus carboplatin
other name: bobei
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: li zhang, doctor
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: yumei wang, docter
phone: +86 0311-67808816
email: wyumei73@mail.ecspc.com
citation: Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.
PMID: 22547591
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Carboplatin
sharing ipd: No