<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/NCT03776604</url>
  </required_header>
  <id_info>
    <org_study_id>CSPC-JYL-SCLC-01</org_study_id>
    <nct_id>NCT03776604</nct_id>
  </id_info>
  <brief_title>PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy</brief_title>
  <official_title>Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Jinyouli (PEGylated Recombinant Human Granulocyte Stimulating Factor, PEG-rhG-CSF) in Preventing Neutropenia After Chemotherapy in Elderly Patients With Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple&#xD;
      chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter,&#xD;
      open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the&#xD;
      inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin:&#xD;
      AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.</measure>
    <time_frame>through first cycle of PEG-rhG-CSF,an average of 1 month</time_frame>
    <description>The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.</measure>
    <time_frame>through second cycle of PEG-rhG-CSF,an average of 1 month</time_frame>
    <description>The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of febrile neutropenia in cycles 1 and 2</measure>
    <time_frame>through 1-2 cycles of PEG-rhG-CSF,an average of 2 month</time_frame>
    <description>Febrile neutropenia (FN) is defined as oral temperature &gt;38.3 ° C (underarm temperature &gt;38.1 ° C) or continuous measurement of oral temperature &gt;38 ° C (underarm temperature &gt;37.8 ° C) in 2 h, and ANC &lt;0.5×10^9/L, or expected to be &lt;0.5×10^9/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ANC recovery time in cycles 1 and 2</measure>
    <time_frame>through 1-2 cycles of PEG-rhG-CSF,an average of 2 month</time_frame>
    <description>Defined as the patients who appear ANC&lt;2.0×10^9/L，from the first day of chemotherapy, to the time of ANC≥ 2.0×10^9/L, take the median.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of infection</measure>
    <time_frame>up to 30 days after the patient study completion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of antibiotic use</measure>
    <time_frame>up to 30 days after the patient study completion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of chemotherapy dose adjustment due to neutropenia</measure>
    <time_frame>through the study completion,an average of 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy delay time</measure>
    <time_frame>through the study completion,an average of 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of chemotherapy delay caused by neutropenia</measure>
    <time_frame>through the study completion,an average of 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of febrile neutropenia in cycles 1 and 2</measure>
    <time_frame>through 1-2 cycles of PEG-rhG-CSF,an average of 2 month</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence and severity of adverse events</measure>
    <time_frame>through the study completion,an average of 3 months</time_frame>
    <description>All adverse events will be recorded from the time of signing the informed consent form to 30 days after the last dose. Adverse events 30 days after the last dose, only those adverse events associated with the study drug were recorded.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">61</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <condition>PEG-rhG-CSF</condition>
  <arm_group>
    <arm_group_label>PEG-rhG-CSF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were &lt;45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.&#xD;
Dosing time: 48 h after chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG-rhG-CSF</intervention_name>
    <description>Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.&#xD;
Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were &lt;45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.&#xD;
Dosing time: 48 h after chemotherapy.</description>
    <arm_group_label>PEG-rhG-CSF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 70 years old, gender is not limited;&#xD;
&#xD;
          -  Small cell lung cancer patients diagnosed by histopathology or cytology;&#xD;
&#xD;
          -  ECOG = 0-1;&#xD;
&#xD;
          -  The estimated survival period is more than 3 months;&#xD;
&#xD;
          -  No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10^9/L,&#xD;
             ANC≥2×10^9/L, PLT≥100×10^9/L before enrollment. And no bleeding tendency;&#xD;
&#xD;
          -  No obvious abnormalities were observed in the electrocardiogram examination;&#xD;
&#xD;
          -  Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of&#xD;
             normal values. If due to liver metastasis, the above indicators should be within 5&#xD;
             times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH&#xD;
             should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it&#xD;
             can be enrolled;&#xD;
&#xD;
          -  Renal function test BUN, UA within 1.5 times the upper limit of normal value,&#xD;
             creatinine clearance rate&gt; 60ml / min;&#xD;
&#xD;
          -  Subjects (or their legal representatives/guardians) must sign an informed consent form&#xD;
             indicating that they understand the purpose of the study, understand the necessary&#xD;
             procedures for the study, and are willing to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;&#xD;
&#xD;
          -  Patients with previous malignant tumors that have not been cured or have bone marrow&#xD;
             metastasis;&#xD;
&#xD;
          -  Patients with prophylactic antibiotics;&#xD;
&#xD;
          -  Accepting other test drugs at the same time or participating in other clinical trials;&#xD;
&#xD;
          -  Those who are allergic to this product or other genetically engineered E. coli-derived&#xD;
             biological products;&#xD;
&#xD;
          -  The patient has any myelodysplastic and other blood system diseases;&#xD;
&#xD;
          -  Patients who have received hematopoietic stem cell transplantation or organ&#xD;
             transplantation;&#xD;
&#xD;
          -  The patient has a severe mental or neurological condition that affects informed&#xD;
             consent and/or adverse reaction presentation or observation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jun Zhao, PhD</last_name>
    <phone>86-010-88196456</phone>
    <email>ohjerry@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hanxiao Chen</last_name>
    <phone>18810526948</phone>
    <email>Hanxiao0628@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bejing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Zhao, PhD</last_name>
      <phone>86-010-88196456</phone>
      <email>ohjerry@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</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>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT03776604
org study id: CSPC-JYL-SCLC-01
nct id: NCT03776604
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple
      chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter,
      open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the
      inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin:
      AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.
primary purpose: Prevention
masking: None (Open Label)
measure: The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
time frame: through first cycle of PEG-rhG-CSF,an average of 1 month
description: The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
measure: The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
time frame: through second cycle of PEG-rhG-CSF,an average of 1 month
description: The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
measure: The incidence of febrile neutropenia in cycles 1 and 2
time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
description: Febrile neutropenia (FN) is defined as oral temperature >38.3 ° C (underarm temperature >38.1 ° C) or continuous measurement of oral temperature >38 ° C (underarm temperature >37.8 ° C) in 2 h, and ANC <0.5×10^9/L, or expected to be <0.5×10^9/L
measure: The ANC recovery time in cycles 1 and 2
time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
description: Defined as the patients who appear ANC<2.0×10^9/L，from the first day of chemotherapy, to the time of ANC≥ 2.0×10^9/L, take the median.
measure: The incidence of infection
time frame: up to 30 days after the patient study completion
measure: The incidence of antibiotic use
time frame: up to 30 days after the patient study completion
measure: Incidence of chemotherapy dose adjustment due to neutropenia
time frame: through the study completion,an average of 3 months
measure: Chemotherapy delay time
time frame: through the study completion,an average of 3 months
measure: Incidence of chemotherapy delay caused by neutropenia
time frame: through the study completion,an average of 3 months
measure: The duration of febrile neutropenia in cycles 1 and 2
time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
measure: Incidence and severity of adverse events
time frame: through the study completion,an average of 3 months
description: All adverse events will be recorded from the time of signing the informed consent form to 30 days after the last dose. Adverse events 30 days after the last dose, only those adverse events associated with the study drug were recorded.
arm group label: PEG-rhG-CSF
arm group type: Experimental
description: Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.
Dosing time: 48 h after chemotherapy.
intervention type: Drug
intervention name: PEG-rhG-CSF
description: Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.
Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.
Dosing time: 48 h after chemotherapy.
arm group label: PEG-rhG-CSF
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Jun Zhao, PhD
phone: 86-010-88196456
email: ohjerry@163.com
last name: Hanxiao Chen
phone: 18810526948
email: Hanxiao0628@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma