xml: <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/NCT06020352</url>
    </required_header>
    <id_info>
      <org_study_id>STAR003</org_study_id>
      <nct_id>NCT06020352</nct_id>
    </id_info>
    <brief_title>The Efficacy and Safety of KN046 Combined With Axitinib</brief_title>
    <official_title>Study on the Efficacy and Safety of KN046 Combined With Acitinib as a Neoadjuvant Therapy in Resectable Stage IB-IIIB Non-small Cell Lung Cancer (NSCLC) Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Pulmonary Hospital, Shanghai, China</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>
        Evaluation of the efficacy of KN046 combined with acitinib as a neoadjuvant therapy for&#xD;
        resectable NSCLC through primary pathological response rate and surgical resection rate&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to evaluate the rate of major pathological remission (MPR) with&#xD;
        preoperative use of KN046 versus axitinib, and thus to assess the efficacy of KN046 in&#xD;
        combination with axitinib in patients with Stage IB-IIIB (Stage IIIB only T3N2M0) NSCLC&#xD;
        (according to the 8th edition of the AJCC classification) who are scheduled to undergo&#xD;
        surgery. Eligible subjects for this study were candidates for surgery for resectable stage&#xD;
        IB-IIIB (stage IIIB only T3N2M0) NSCLC as judged by the investigator, with no evidence of&#xD;
        distant metastases as assessed, and no evidence of unresectable local regional tumour&#xD;
        extension.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
    <phase>Phase 2/Phase 3</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>MPR</measure>
      <time_frame>one month within postsurgery</time_frame>
      <description>MPR is defined as the presence of ≤ 10% of active tumor cells in postoperative pathology (primary lesion).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Surgical resection rate</measure>
      <time_frame>six weeks after last cycle of neoadjuvant therapy</time_frame>
      <description>Surgical resection rate: refers to the proportion of subjects who completed the surgery according to the plan, defined as the distance from the last neoadjuvant treatment administration, and the surgical time ≤ 6 weeks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complication rate</measure>
      <time_frame>three months within postsurgery</time_frame>
      <description>The incidence and severity of AE (classified according to CTCAE v5.0), severity, and their relationship with experimental treatment; Any abnormal results of laboratory tests, vital signs, and physical examinations;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pCR</measure>
      <time_frame>one month within postsurgery</time_frame>
      <description>PCR is defined as postoperative pathology (primary lesion) showing the absence of viable tumor cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ORR</measure>
      <time_frame>one month within postsurgery</time_frame>
      <description>Defined as the proportion of subjects who achieved complete remission (CR) or partial remission (PR) according to RECIST 1.1</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>NSCLC</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>KN046 combined with axitinib as a neoadjuvant treatment regimen</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KN046 plus Axitinib</intervention_name>
      <description>KN046 combined with axitinib as a neoadjuvant treatment regimen</description>
      <arm_group_label>Treatment group</arm_group_label>
      <other_name>surgical resection and selective adjuvant therapy with KN046</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The subject is at least 18 years old and&lt;75 years old on the day of signing the&#xD;
               informed consent form, regardless of gender, and is willing to follow the research&#xD;
               procedure;&#xD;
  &#xD;
            2. Confirmed by histology or cytology as non-small cell lung cancer;&#xD;
  &#xD;
            3. NSCLC patients evaluated by researchers as resectable in stage IB-IIIB (stage IIIB&#xD;
               only limited to T3N2M0) (AJCC 8th edition);&#xD;
  &#xD;
            4. Has not received any anti-tumor treatment in the past, including but not limited to&#xD;
               systemic chemotherapy, immunotherapy, or radiotherapy;&#xD;
  &#xD;
            5. No allergenic EGFR mutation or ALK change;&#xD;
  &#xD;
            6. The ECOG score is 0-1 points.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The lesion of squamous non-small cell lung cancer presents as a central type of lung&#xD;
               cancer accompanied by cavity formation or invasion of blood vessels, with a high risk&#xD;
               of hemoptysis;&#xD;
  &#xD;
            2. Previously or currently suffering from interstitial pneumonia/lung disease that&#xD;
               requires systemic hormone therapy;&#xD;
  &#xD;
            3. Previous history of allogeneic bone marrow or organ transplantation;&#xD;
  &#xD;
            4. Subjects who have undergone major surgical treatment (such as abdominal or thoracic&#xD;
               surgery; excluding diagnostic puncture or peripheral vascular pathway replacement&#xD;
               surgery) or have not recovered from surgical treatment within 28 days before the&#xD;
               administration of this trial;&#xD;
  &#xD;
            5. Prior to allocation, they have received systemic anti-cancer treatment, including&#xD;
               research drugs targeting current malignant tumors;&#xD;
  &#xD;
            6. Other known malignant tumors are progressing or require active treatment within the&#xD;
               past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell&#xD;
               carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in situ) who&#xD;
               have received possible radical treatment are not excluded;&#xD;
  &#xD;
            7. Pregnant and/or lactating women.&#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>l: 2031222@tongji.edu.cn Chen, Dr</last_name>
      <role>Study Chair</role>
      <affiliation>Shanghai Pulmonary Hospital, Shanghai, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chang Chen, Dr</last_name>
      <phone>65115006</phone>
      <phone_ext>021</phone_ext>
      <email>2031222@tongji.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bentong Yu, Dr</last_name>
        <phone>021-65115006</phone>
        <email>1151697503@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanghai Pulmonary Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200433</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chang Chen, MD, PhD</last_name>
        <phone>+86-021-65115006</phone>
        <phone_ext>2074</phone_ext>
        <email>chenthoracic@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Pulmonary Hospital, Shanghai, China</investigator_affiliation>
      <investigator_full_name>Chang Chen</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>KN046</keyword>
    <keyword>Axitinib</keyword>
    <keyword>neoadjuvant</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Axitinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020352
  org study id: STAR003
  nct id: NCT06020352
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Evaluation of the efficacy of KN046 combined with acitinib as a neoadjuvant therapy for
        resectable NSCLC through primary pathological response rate and surgical resection rate
  The purpose of this study is to evaluate the rate of major pathological remission (MPR) with
        preoperative use of KN046 versus axitinib, and thus to assess the efficacy of KN046 in
        combination with axitinib in patients with Stage IB-IIIB (Stage IIIB only T3N2M0) NSCLC
        (according to the 8th edition of the AJCC classification) who are scheduled to undergo
        surgery. Eligible subjects for this study were candidates for surgery for resectable stage
        IB-IIIB (stage IIIB only T3N2M0) NSCLC as judged by the investigator, with no evidence of
        distant metastases as assessed, and no evidence of unresectable local regional tumour
        extension.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: MPR
  time frame: one month within postsurgery
  description: MPR is defined as the presence of ≤ 10% of active tumor cells in postoperative pathology (primary lesion).
  measure: Surgical resection rate
  time frame: six weeks after last cycle of neoadjuvant therapy
  description: Surgical resection rate: refers to the proportion of subjects who completed the surgery according to the plan, defined as the distance from the last neoadjuvant treatment administration, and the surgical time ≤ 6 weeks.
  measure: Complication rate
  time frame: three months within postsurgery
  description: The incidence and severity of AE (classified according to CTCAE v5.0), severity, and their relationship with experimental treatment; Any abnormal results of laboratory tests, vital signs, and physical examinations;
  measure: pCR
  time frame: one month within postsurgery
  description: PCR is defined as postoperative pathology (primary lesion) showing the absence of viable tumor cells
  measure: ORR
  time frame: one month within postsurgery
  description: Defined as the proportion of subjects who achieved complete remission (CR) or partial remission (PR) according to RECIST 1.1
  arm group label: Treatment group
  arm group type: Experimental
  description: KN046 combined with axitinib as a neoadjuvant treatment regimen
  intervention type: Drug
  intervention name: KN046 plus Axitinib
  description: KN046 combined with axitinib as a neoadjuvant treatment regimen
  arm group label: Treatment group
  other name: surgical resection and selective adjuvant therapy with KN046
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: l: 2031222@tongji.edu.cn Chen, Dr
  role: Study Chair
  affiliation: Shanghai Pulmonary Hospital, Shanghai, China
  last name: Chang Chen, Dr
  phone: 65115006
  phone ext: 021
  email: 2031222@tongji.edu.cn
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Pulmonary Hospital, Shanghai, China
  investigator full name: Chang Chen
  investigator title: Professor
  mesh term: Axitinib
  sharing ipd: No