<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/NCT03798743</url>
  </required_header>
  <id_info>
    <org_study_id>SUCCESS</org_study_id>
    <nct_id>NCT03798743</nct_id>
  </id_info>
  <brief_title>Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study</brief_title>
  <acronym>SUCCESS</acronym>
  <official_title>Single Center, Single Arm Phase II Study on Efficacy Evaluation and Bio-marker Analysis of Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hunan Province Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hunan Province Tumor Hospital</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>
      The study aim to Evaluate the combination of ididilimumab and docetaxel alone in the&#xD;
      treatment of previous platinum-containing double-drug chemotherapy according to RECIST&#xD;
      1.1Objective remission rate of advanced or metastatic non-small cell lung cancer with&#xD;
      negative, driving gene negative (EGFR, ALK, ROS1); (ORR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a single case of syndilizumab plus docetaxel monotherapy in a Chinese-negative&#xD;
      late-stage or metastatic non-small cell lung cancer (NSCLC) failed platinum-containing&#xD;
      dual-drug chemotherapy. Center, single arm phase II study. In this study, 30 patients with&#xD;
      advanced or metastatic non-small cell lung cancer who had failed platinum-containing&#xD;
      dual-drug chemotherapy were treated with rituximab plus docetaxel every 3 weeks until disease&#xD;
      progression and intolerance. Toxicity, withdrawal of informed consent, death or other&#xD;
      cessation of treatment as prescribed by the program, whichever occurs first. The primary end&#xD;
      point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review&#xD;
      Board (IRRC). The longest treatment time for ididibizumab is 24 months. An interim analysis&#xD;
      will be conducted during the course of the study. The results and reports will be provided to&#xD;
      the Independent Data Audit Committee (IDMC), which determines whether the trial is valid&#xD;
      based on the valid cut-off value of the trial and whether the study data can be submitted in&#xD;
      advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter&#xD;
      will be finalized and approved by IDMC and the sponsor. The responsibilities and related&#xD;
      procedures of IDMC members will be defined in the IDMC charter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ORR (Overall response rate)</measure>
    <time_frame>Approximately 1 years</time_frame>
    <description>Evaluation of objective response rates in patients with advanced or metastatic non-small cell lung cancer who failed to receive platinum-based dual-drug chemotherapy in response to RECIST 1.1 and in combination with docetaxel and docetaxel</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS (progression free survival time)</measure>
    <time_frame>Approximately 1 years</time_frame>
    <description>Assessment of the disease-free progression of the subject according to RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS (overall survival time)</measure>
    <time_frame>Approximately 1 years</time_frame>
    <description>Assess the overall survival of the subject according to RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR (duration of response)</measure>
    <time_frame>Approximately 1 years</time_frame>
    <description>Assessment of subject's duration of remission according to RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR (disease control rate)</measure>
    <time_frame>Approximately 1 years</time_frame>
    <description>Assessment of subject's disease control rate according to RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TTR (time to response)</measure>
    <time_frame>Approximately 1 years</time_frame>
    <description>Assessment of subject's objective response time according to RECIST 1.1</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Sintilimab Combined With Docetaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sintilimab Combined With Docetaxel</intervention_name>
    <description>Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w</description>
    <arm_group_label>Sintilimab Combined With Docetaxel</arm_group_label>
    <other_name>SCD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sign written informed consent before any trial-related processes are implemented&#xD;
&#xD;
          -  Age ≥ 18 years old and ≤ 75 years old&#xD;
&#xD;
          -  Life expectancy exceeds 3 months&#xD;
&#xD;
          -  The investigator confirmed at least one measurable lesion according to the RECIST 1.1&#xD;
             standard&#xD;
&#xD;
          -  Histological or cytological diagnosis of NSCLC and stage IIIB/IV stage tumors&#xD;
             (according to the International Association for the Study of Lung Cancer)Chest tumor&#xD;
             staging manual 8th edition judgment) or in multimodal treatment (radiotherapy,&#xD;
             surgical resection or radical chemoradiotherapy local treatment)Subjects with relapse&#xD;
             or disease progression after treatment for locally advanced disease.&#xD;
&#xD;
          -  Subjects must have previously been treated with a platinum-containing dual&#xD;
             chemotherapy (carboplatin or cisplatin) regimen for advanced or metastatic&#xD;
             tumorsisease progression occurred during or after the period.&#xD;
&#xD;
             i) receiving maintenance therapy (referring to treatment with no progress after&#xD;
             treatment with a platinum-containing dual chemotherapy regimen) and progress Subjects&#xD;
             are eligible for inclusion. Ii) treatment of locally advanced disease with&#xD;
             platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy, and&#xD;
             completion of treatment Subjects with tumor recurrence or metastasis within 6 months&#xD;
             after treatment are eligible.selected.&#xD;
&#xD;
        Iii) administration of platinum-containing adjuvant, neoadjuvant therapy or radical&#xD;
        chemoradiotherapy for treatment of locally advanced disease &gt;6 months laterTumor&#xD;
        recurrence, and later progressed during or after treatment of a recurrent tumor with a&#xD;
        platinum-based regimen Subjects are eligible for inclusion.&#xD;
&#xD;
          -  Patients confirmed by histological specimens who are not eligible for EGFR, ALK or&#xD;
             ROS1 targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK,&#xD;
             ROS1 gene rearrangement);&#xD;
&#xD;
          -  The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1&#xD;
&#xD;
          -  Good hematopoietic function, defined as absolute neutrophil count ≥1.5×109/L, platelet&#xD;
             count ≥100×109/L, hemoglobin≥90g/L [no blood transfusion or erythropoietin (EPO)&#xD;
             within 7 days] Dependency];&#xD;
&#xD;
          -  Good liver function, defined as total bilirubin level ≤ normal upper limit (ULN);&#xD;
             patients without liver metastases, Aspartate aminotransferase (AST) and alanine&#xD;
             aminotransferase (ALT) levels ≤ 1.5 times ULN, alkaline phosphatase ≤ 2.5 times ULN&#xD;
             For patients with recorded liver metastases, AST and ALT levels ≤ 5 times ULN;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Small cell lung cancer&#xD;
&#xD;
          -  Currently participating in interventional clinical research treatment, or receiving&#xD;
             other research medications within 4 weeks prior to the first dose or Used research&#xD;
             equipment;&#xD;
&#xD;
          -  Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2&#xD;
             drugs or for another stimulus or association a drug that inhibits T cell receptors&#xD;
             (eg, CTLA-4, OX-40, CD137);&#xD;
&#xD;
          -  Systemic systemic treatment of Chinese patent medicines or immunomodulatory drugs&#xD;
             (including thymosin, interferon, interleukin, except for local use of pleural&#xD;
             effusion) with anti-lung cancer indications within 2 weeks prior to the first dose, or&#xD;
             before the first dose Major surgical treatment within 3 weeks;&#xD;
&#xD;
          -  Pulmonary radiation therapy &gt;30 Gy within 6 months prior to first dose&#xD;
&#xD;
          -  Completed palliative radiotherapy within 7 days prior to the first dose&#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>Yongchang Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hunan Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hunan Provincal Tumor Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hunan Province Tumor Hospital</investigator_affiliation>
    <investigator_full_name>Yongchang Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Non-small Cell Lung Cancer</keyword>
  <keyword>Sintilimab</keyword>
  <keyword>Docetaxel</keyword>
  <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>Docetaxel</mesh_term>
  </intervention_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/NCT03798743
org study id: SUCCESS
nct id: NCT03798743
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aim to Evaluate the combination of ididilimumab and docetaxel alone in the
      treatment of previous platinum-containing double-drug chemotherapy according to RECIST
      1.1Objective remission rate of advanced or metastatic non-small cell lung cancer with
      negative, driving gene negative (EGFR, ALK, ROS1); (ORR).
This study is a single case of syndilizumab plus docetaxel monotherapy in a Chinese-negative
      late-stage or metastatic non-small cell lung cancer (NSCLC) failed platinum-containing
      dual-drug chemotherapy. Center, single arm phase II study. In this study, 30 patients with
      advanced or metastatic non-small cell lung cancer who had failed platinum-containing
      dual-drug chemotherapy were treated with rituximab plus docetaxel every 3 weeks until disease
      progression and intolerance. Toxicity, withdrawal of informed consent, death or other
      cessation of treatment as prescribed by the program, whichever occurs first. The primary end
      point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review
      Board (IRRC). The longest treatment time for ididibizumab is 24 months. An interim analysis
      will be conducted during the course of the study. The results and reports will be provided to
      the Independent Data Audit Committee (IDMC), which determines whether the trial is valid
      based on the valid cut-off value of the trial and whether the study data can be submitted in
      advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter
      will be finalized and approved by IDMC and the sponsor. The responsibilities and related
      procedures of IDMC members will be defined in the IDMC charter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ORR (Overall response rate)
time frame: Approximately 1 years
description: Evaluation of objective response rates in patients with advanced or metastatic non-small cell lung cancer who failed to receive platinum-based dual-drug chemotherapy in response to RECIST 1.1 and in combination with docetaxel and docetaxel
measure: PFS (progression free survival time)
time frame: Approximately 1 years
description: Assessment of the disease-free progression of the subject according to RECIST 1.1
measure: OS (overall survival time)
time frame: Approximately 1 years
description: Assess the overall survival of the subject according to RECIST 1.1
measure: DOR (duration of response)
time frame: Approximately 1 years
description: Assessment of subject's duration of remission according to RECIST 1.1
measure: DCR (disease control rate)
time frame: Approximately 1 years
description: Assessment of subject's disease control rate according to RECIST 1.1
measure: TTR (time to response)
time frame: Approximately 1 years
description: Assessment of subject's objective response time according to RECIST 1.1
arm group label: Sintilimab Combined With Docetaxel
arm group type: Experimental
description: Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer
intervention type: Drug
intervention name: Sintilimab Combined With Docetaxel
description: Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w
arm group label: Sintilimab Combined With Docetaxel
other name: SCD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yongchang Zhang, MD
role: Principal Investigator
affiliation: Hunan Cancer Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Hunan Province Tumor Hospital
investigator full name: Yongchang Zhang
investigator title: Professor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel