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Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU) (LIPUSU)

Primary Purpose

Squamous Non-small-cell Lung Cancer

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Paclitaxel Liposome
Gemcitabine
Cisplatin
Sponsored by
Nanjing Luye Sike Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Non-small-cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-75 years old, both gender;
  2. ECOG: 0-1;
  3. Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ;
  4. No prior chemotherapy, biological therapy or immunotherapy; or subjects have recurrence and metastasis more than 6 months after the end of chemotherapy, but not gemcitabine or paclitaxel;
  5. At least one radiographically measurable or assessable lesion on chest CG according to RECIST1.1 (response evaluation criteria of solid tumors); regional lymph node metastases may also be measured or assessed by imaging (mediastinal lymph nodes);
  6. Life expectancy of at least 12 weeks;

  7. Before treatment, blood tests or biochemical measurements must meet the following criteria:

    • White blood cell count (WBC)≥ 4.0*10^9/L;
    • Neutrophil count (ANC)≥ 2.0*10^9/L;
    • Platelet count (PLT)≥ 100*10^9/L;
    • Hemoglobin (Hb)≥ 100g/L;
    • Hepatic function: serum bilirubin ≤ 1.5 times the upper normal limit,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit;
    • Renal function: creatinine ≤ 1.5 times the upper normal limit;
  8. Signed informed consent.

Exclusion Criteria:

  1. Hypersensitivity reaction to the interventional drugs;
  2. Pregnant or breastfeeding;
  3. Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period;
  4. Brain metastase ;
  5. Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    LP group

    GP group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Progression Free Survival
    Progression free survival will be calculated from study entry to documented disease progression using RECISTv1.1 or death from any cause, whichever occurs first.

    Secondary Outcome Measures

    Objective Response Rate
    Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .
    Overall Survival
    Overall survival is defined from study entry to the date of death from any cause.
    Adverse events
    Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0
    Quality of Life questionnaire
    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).
    Correlation between gene sequence or expression level and therapeutic effect
    Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing

    Full Information

    First Posted
    December 4, 2016
    Last Updated
    February 10, 2020
    Sponsor
    Nanjing Luye Sike Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02996214
    Brief Title
    Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU)
    Acronym
    LIPUSU
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    December 2019 (Actual)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing Luye Sike Pharmaceutical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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 .
    Detailed Description
    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Squamous Non-small-cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    536 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LP group
    Arm Type
    Experimental
    Arm 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 Title
    GP group
    Arm Type
    Active Comparator
    Arm 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(s)
    Paclitaxel Liposome
    Other Intervention Name(s)
    Lipusu®
    Intervention Description
    Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Other Intervention Name(s)
    Gemzar®
    Intervention Description
    Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Other Intervention Name(s)
    Nuoxin®
    Intervention Description
    Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
    Primary Outcome Measure Information:
    Title
    Progression Free Survival
    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.
    Time Frame
    From study entry to measured progressive disease, up to 2 years
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate
    Description
    Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .
    Time Frame
    From study entry to measured progressive disease, up to 2 years
    Title
    Overall Survival
    Description
    Overall survival is defined from study entry to the date of death from any cause.
    Time Frame
    From study entry to death from any cause, up to 2 years
    Title
    Adverse events
    Description
    Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0
    Time Frame
    From baseline until 21 days after the last dose
    Title
    Quality of Life questionnaire
    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).
    Time Frame
    From study entry to measured progressive disease, up to 2 years
    Title
    Correlation between gene sequence or expression level and therapeutic effect
    Description
    Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing
    Time Frame
    From study entry untill radiological disease progression, up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18-75 years old, both gender; ECOG: 0-1; Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ; No prior chemotherapy, biological therapy or immunotherapy; or subjects have recurrence and metastasis more than 6 months after the end of chemotherapy, but not gemcitabine or paclitaxel; At least one radiographically measurable or assessable lesion on chest CG according to RECIST1.1 (response evaluation criteria of solid tumors); regional lymph node metastases may also be measured or assessed by imaging (mediastinal lymph nodes); Life expectancy of at least 12 weeks; Before treatment, blood tests or biochemical measurements must meet the following criteria: White blood cell count (WBC)≥ 4.0*10^9/L; Neutrophil count (ANC)≥ 2.0*10^9/L; Platelet count (PLT)≥ 100*10^9/L; Hemoglobin (Hb)≥ 100g/L; Hepatic function: serum bilirubin ≤ 1.5 times the upper normal limit,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit; Renal function: creatinine ≤ 1.5 times the upper normal limit; Signed informed consent. Exclusion Criteria: Hypersensitivity reaction to the interventional drugs; Pregnant or breastfeeding; Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period; Brain metastase ; Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    caicun zhou, doctor
    Organizational Affiliation
    Shanghai Pulmonary Hospital, Shanghai, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34699693
    Citation
    Zhang J, Pan Y, Shi Q, Zhang G, Jiang L, Dong X, Gu K, Wang H, Zhang X, Yang N, Li Y, Xiong J, Yi T, Peng M, Song Y, Fan Y, Cui J, Chen G, Tan W, Zang A, Guo Q, Zhao G, Wang Z, He J, Yao W, Wu X, Chen K, Hu X, Hu C, Yue L, Jiang D, Wang G, Liu J, Yu G, Li J, Bai J, Xie W, Zhao W, Wu L, Zhou C. Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study. Cancer Commun (Lond). 2022 Jan;42(1):3-16. doi: 10.1002/cac2.12225. Epub 2021 Oct 26.
    Results Reference
    derived

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    Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU)

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