<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/NCT02996214</url>
  </required_header>
  <id_info>
    <org_study_id>LY-TM-LPS-2016-01</org_study_id>
    <nct_id>NCT02996214</nct_id>
  </id_info>
  <brief_title>Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU)</brief_title>
  <acronym>LIPUSU</acronym>
  <official_title>A Multicenter, Randomized, Open-label, Parallel-group Study of Paclitaxel Liposome and Cisplatin Compared With Gemcitabine and Cisplatin as First-line Therapy in Advanced Squamous Non-Small-Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Luye Sike Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Luye Sike Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy and the safety of paclitaxel&#xD;
      liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in&#xD;
      advanced squamous non-small-cell lung cancer .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the efficacy and safety of paclitaxel liposome&#xD;
      and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced&#xD;
      squamous non-small-cell lung cancer .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>Phase 4</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>Progression Free Survival</measure>
    <time_frame>From study entry to measured progressive disease, up to 2 years</time_frame>
    <description>Progression free survival will be calculated from study entry to documented disease progression using RECISTv1.1 or death from any cause, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>From study entry to measured progressive disease, up to 2 years</time_frame>
    <description>Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From study entry to death from any cause, up to 2 years</time_frame>
    <description>Overall survival is defined from study entry to the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>From baseline until 21 days after the last dose</time_frame>
    <description>Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life questionnaire</measure>
    <time_frame>From study entry to measured progressive disease, up to 2 years</time_frame>
    <description>The quality of life is assessed using the European Organization for the Research and Treatment of Cancer Questionnaire Core-30 (EORTC QLQ-C30) and Quality of Life Questionnaire Lung Cancer 13(QLQ-LC13).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between gene sequence or expression level and therapeutic effect</measure>
    <time_frame>From study entry untill radiological disease progression, up to 2 years</time_frame>
    <description>Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">536</enrollment>
  <condition>Squamous Non-small-cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>LP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liposome paclitaxel(Lipusu®) plus cisplatin. Paclitaxel liposome Sterile injection powder 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gemcitabine (Gemzar®) plus cisplatin. Gemcitabine hydrochloride for injection 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel Liposome</intervention_name>
    <description>Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.</description>
    <arm_group_label>LP group</arm_group_label>
    <other_name>Lipusu®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.</description>
    <arm_group_label>GP group</arm_group_label>
    <other_name>Gemzar®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.</description>
    <arm_group_label>GP group</arm_group_label>
    <arm_group_label>LP group</arm_group_label>
    <other_name>Nuoxin®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18-75 years old, both gender;&#xD;
&#xD;
          2. ECOG: 0-1;&#xD;
&#xD;
          3. Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or&#xD;
             cytologically ;&#xD;
&#xD;
          4. No prior chemotherapy, biological therapy or immunotherapy; or subjects have&#xD;
             recurrence and metastasis more than 6 months after the end of chemotherapy, but not&#xD;
             gemcitabine or paclitaxel;&#xD;
&#xD;
          5. At least one radiographically measurable or assessable lesion on chest CG according to&#xD;
             RECIST1.1 (response evaluation criteria of solid tumors); regional lymph node&#xD;
             metastases may also be measured or assessed by imaging (mediastinal lymph nodes);&#xD;
&#xD;
          6. Life expectancy of at least 12 weeks;&#xD;
&#xD;
          7. Before treatment, blood tests or biochemical measurements must meet the following&#xD;
             criteria:&#xD;
&#xD;
               -  White blood cell count (WBC)≥ 4.0*10^9/L;&#xD;
&#xD;
               -  Neutrophil count (ANC)≥ 2.0*10^9/L;&#xD;
&#xD;
               -  Platelet count (PLT)≥ 100*10^9/L;&#xD;
&#xD;
               -  Hemoglobin (Hb)≥ 100g/L;&#xD;
&#xD;
               -  Hepatic function: serum bilirubin ≤ 1.5 times the upper normal limit,aspartate&#xD;
                  aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper&#xD;
                  normal limit;&#xD;
&#xD;
               -  Renal function: creatinine ≤ 1.5 times the upper normal limit;&#xD;
&#xD;
          8. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity reaction to the interventional drugs;&#xD;
&#xD;
          2. Pregnant or breastfeeding;&#xD;
&#xD;
          3. Women or men of childbearing age who disagree with the use of effective contraceptive&#xD;
             measures during the study period;&#xD;
&#xD;
          4. Brain metastase ;&#xD;
&#xD;
          5. Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>caicun zhou, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Pulmonary Hospital, Shanghai, China</affiliation>
  </overall_official>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</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>Gemcitabine</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/NCT02996214
org study id: LY-TM-LPS-2016-01
nct id: NCT02996214
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the efficacy and the safety of paclitaxel
      liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in
      advanced squamous non-small-cell lung cancer .
The purpose of this study is to investigate the efficacy and safety of paclitaxel liposome
      and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced
      squamous non-small-cell lung cancer .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: From study entry to measured progressive disease, up to 2 years
description: Progression free survival will be calculated from study entry to documented disease progression using RECISTv1.1 or death from any cause, whichever occurs first.
measure: Objective Response Rate
time frame: From study entry to measured progressive disease, up to 2 years
description: Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .
measure: Overall Survival
time frame: From study entry to death from any cause, up to 2 years
description: Overall survival is defined from study entry to the date of death from any cause.
measure: Adverse events
time frame: From baseline until 21 days after the last dose
description: Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0
measure: Quality of Life questionnaire
time frame: From study entry to measured progressive disease, up to 2 years
description: The quality of life is assessed using the European Organization for the Research and Treatment of Cancer Questionnaire Core-30 (EORTC QLQ-C30) and Quality of Life Questionnaire Lung Cancer 13(QLQ-LC13).
measure: Correlation between gene sequence or expression level and therapeutic effect
time frame: From study entry untill radiological disease progression, up to 2 years
description: Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing
arm group label: LP group
arm group type: Experimental
description: Liposome paclitaxel(Lipusu®) plus cisplatin. Paclitaxel liposome Sterile injection powder 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
arm group label: GP group
arm group type: Active Comparator
description: Gemcitabine (Gemzar®) plus cisplatin. Gemcitabine hydrochloride for injection 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
intervention type: Drug
intervention name: Paclitaxel Liposome
description: Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
arm group label: LP group
other name: Lipusu®
intervention type: Drug
intervention name: Gemcitabine
description: Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.
arm group label: GP group
other name: Gemzar®
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
arm group label: GP group
arm group label: LP group
other name: Nuoxin®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: caicun zhou, doctor
role: Principal Investigator
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Gemcitabine
sharing ipd: No