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Endostar First-line Treatment of Advanced NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Endostar
Gemcitabine
Cisplatin
Sponsored by
China Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring endostar

Eligibility Criteria

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

Inclusion Criteria:

  • Cytological and histological confirmation(Do not accept single sputum cytology in the diagnosis of patients) in patients diagnosed of lung squamous carcinoma; According to a new IASLC (International Association for the Study of Lung Cance) 2009 lung cancer TNM (tumor node metastasis) stages judged stage IIIB or IV non-small cell lung cancer.
  • Must have at least one evaluated lesion,according to the RECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
  • Male or female, age between 18 and 75 years old ;
  • ECOG(Eastern Cooperative Oncology Group) PS (performance status ) 0~1;
  • Expected survival period ≥ 3 months or more
  • Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
  • Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); aspartate aminotransferase(AST) and Alanine aminotransferase(ALT) acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
  • Enough renal function:serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
  • The electrocardiogram (ecg) basically normal,the body had no to heal wounds
  • No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start.
  • Patients had surgery before,but have more than 4 weeks before the study start, and the patient has recovered;
  • Women with completed uterus before intact in the group within 28 days must have a negative pregnancy test results (unless amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery).
  • Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
  • Sign the informed consent.

Exclusion Criteria:

  • Pregnancy, nursing mothers, or female patients with fertility but no contraception.
  • Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
  • Original serious heart disease, including: congestive heart failure, uncontrolled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
  • With uncontrolled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontrolled primary brain tumors or central nervous system(CNS) metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
  • With a bleeding tendency
  • Researchers believe that patients should not participate in this test.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Endostar + Gemcitabine and Cisplatin

    Gemcitabine and Cisplatin

    Arm Description

    Patients in this group will be given endostar combined with gemcitabine and cisplatine.

    Patients in this group will be given gemcitabine and cisplatine.

    Outcomes

    Primary Outcome Measures

    Progression-free Survival (PFS)
    PFS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknown death , or other anti tumor therapy was used.

    Secondary Outcome Measures

    ORR
    overall remission rate

    Full Information

    First Posted
    April 5, 2017
    Last Updated
    April 18, 2017
    Sponsor
    China Medical University, China
    Collaborators
    The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Tumor Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03123445
    Brief Title
    Endostar First-line Treatment of Advanced NSCLC
    Official Title
    The Efficacy and Safety of Continuous Administration of Endostar Combined With Chemotherapy for Patients With Advanced no Small Cell Lung Cancer: An Open-label, no Randomized Controlled Multicenter Phase II Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2017 (Anticipated)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    September 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Medical University, China
    Collaborators
    The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Tumor Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment.
    Detailed Description
    Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment. main objectives: PFS (progression-free survival) the secondary goal: ORR (overall response rate), DCR (disease control rate) and OS(overall survival)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Small Cell Lung Cancer
    Keywords
    endostar

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endostar + Gemcitabine and Cisplatin
    Arm Type
    Experimental
    Arm Description
    Patients in this group will be given endostar combined with gemcitabine and cisplatine.
    Arm Title
    Gemcitabine and Cisplatin
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group will be given gemcitabine and cisplatine.
    Intervention Type
    Drug
    Intervention Name(s)
    Endostar
    Other Intervention Name(s)
    Recombinant Human Endostatin Injection
    Intervention Description
    Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Description
    Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total
    Primary Outcome Measure Information:
    Title
    Progression-free Survival (PFS)
    Description
    PFS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknown death , or other anti tumor therapy was used.
    Time Frame
    Time Frame: up to month 36
    Secondary Outcome Measure Information:
    Title
    ORR
    Description
    overall remission rate
    Time Frame
    Time Frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.

    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: Cytological and histological confirmation(Do not accept single sputum cytology in the diagnosis of patients) in patients diagnosed of lung squamous carcinoma; According to a new IASLC (International Association for the Study of Lung Cance) 2009 lung cancer TNM (tumor node metastasis) stages judged stage IIIB or IV non-small cell lung cancer. Must have at least one evaluated lesion,according to the RECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm); Male or female, age between 18 and 75 years old ; ECOG(Eastern Cooperative Oncology Group) PS (performance status ) 0~1; Expected survival period ≥ 3 months or more Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL; Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); aspartate aminotransferase(AST) and Alanine aminotransferase(ALT) acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN); Enough renal function:serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min. The electrocardiogram (ecg) basically normal,the body had no to heal wounds No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start. Patients had surgery before,but have more than 4 weeks before the study start, and the patient has recovered; Women with completed uterus before intact in the group within 28 days must have a negative pregnancy test results (unless amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery). Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions; Sign the informed consent. Exclusion Criteria: Pregnancy, nursing mothers, or female patients with fertility but no contraception. Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay; Original serious heart disease, including: congestive heart failure, uncontrolled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension; With uncontrolled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontrolled primary brain tumors or central nervous system(CNS) metastases illness, with obvious symptoms in cranial hypertension or nerve spirit; With a bleeding tendency Researchers believe that patients should not participate in this test.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    liu yunpeng, PhD
    Phone
    00862483282312
    Email
    cmu_trial@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    jin bo, PhD
    Phone
    00862483282542
    Email
    jb_cmu@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    liu yunpeng, PhD
    Organizational Affiliation
    First Hospital of China Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25818734
    Citation
    Wang J, Gu LJ, Fu CX, Cao Z, Chen QY. Endostar combined with chemotherapy compared with chemotherapy alone in the treatment of nonsmall lung carcinoma: A meta-analysis based on Chinese patients. Indian J Cancer. 2014 Mar;51 Suppl 3:e106-9. doi: 10.4103/0019-509X.154099.
    Results Reference
    background
    PubMed Identifier
    27428214
    Citation
    Hu W, Fang J, Nie J, Dai L, Zhang J, Chen X, Ma X, Tian G, Wu D, Han S, Han J, Wang Y, Long J. Efficacy and safety of extended use of platinum-based doublet chemotherapy plus endostatin in patients with advanced nonsmall cell lung cancer. Medicine (Baltimore). 2016 Jul;95(28):e4183. doi: 10.1097/MD.0000000000004183.
    Results Reference
    background
    PubMed Identifier
    22917490
    Citation
    Rong B, Yang S, Li W, Zhang W, Ming Z. Systematic review and meta-analysis of Endostar (rh-endostatin) combined with chemotherapy versus chemotherapy alone for treating advanced non-small cell lung cancer. World J Surg Oncol. 2012 Aug 24;10:170. doi: 10.1186/1477-7819-10-170.
    Results Reference
    background
    PubMed Identifier
    26434908
    Citation
    Zhang FL, Gao EY, Shu RB, Wang H, Zhang Y, Sun P, Li M, Tang W, Jiang BQ, Chen SQ, Cui FB. Human Recombinant Endostatin Combined with Cisplatin Based Doublets in Treating Patients with Advanced NSCLC and Evaluation by CT Perfusion Imaging. Asian Pac J Cancer Prev. 2015;16(15):6765-8. doi: 10.7314/apjcp.2015.16.15.6765.
    Results Reference
    result

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    Endostar First-line Treatment of Advanced NSCLC

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