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/NCT06010303</url>
    </required_header>
    <id_info>
      <org_study_id>BGB-A317-LBL-007-202</org_study_id>
      <nct_id>NCT06010303</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma</brief_title>
    <official_title>A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BeiGene</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>BeiGene</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized, open-label study to compare how well LBL-007 works in combination with&#xD;
        tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the&#xD;
        first-line treatment in participants with inoperable locally advanced or metastatic&#xD;
        esophageal squamous cell carcinoma (ESCC).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>Approximately 14 months</time_frame>
      <description>Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>Approximately 14 months</time_frame>
      <description>Time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Approximately 14 months</time_frame>
      <description>Time from the first determination of an overall response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>Approximately 14 months</time_frame>
      <description>Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Approximately 14 months</time_frame>
      <description>Number of participants with AEs, including findings from physical examinations, electrocardiograms, and laboratory assessments according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">116</enrollment>
    <condition>Esophageal Cancer</condition>
    <condition>Esophageal Squamous Cell Carcinoma</condition>
    <condition>Esophageal Squamous Cell Carcinoma by AJCC V8 Stage</condition>
    <arm_group>
      <arm_group_label>LBL-007</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>LBL-007 in combination with tislelizumab plus chemotherapy doublet.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tislelizumab and Chemotherapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Tislelizumab plus chemotherapy doublet.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LBL-007</intervention_name>
      <description>LBL-007 will be administered at a standard dose intravenously.</description>
      <arm_group_label>LBL-007</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tislelizumab</intervention_name>
      <description>Tislelizumab will be administered at a standard dose intravenously.</description>
      <arm_group_label>LBL-007</arm_group_label>
      <arm_group_label>Tislelizumab and Chemotherapy</arm_group_label>
      <other_name>BGB-A317</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chemotherapy Doublet</intervention_name>
      <description>Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel&#xD;
  Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.</description>
      <arm_group_label>LBL-007</arm_group_label>
      <arm_group_label>Tislelizumab and Chemotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to provide written informed consent and can agree to comply with the study&#xD;
               requirements.&#xD;
  &#xD;
            -  Participants with metastatic ESCC or unresectable, locally advanced ESCC.&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of ESCC.&#xD;
  &#xD;
            -  Can provide a tumor sample.&#xD;
  &#xD;
            -  At least 1 measurable lesion as defined by RECIST v1.1.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior treatment for advanced or metastatic ESCC within the past 6 months&#xD;
  &#xD;
            -  Locally advanced ESCC that is either resectable or potentially curable with definitive&#xD;
               chemoradiation treatment per local investigator&#xD;
  &#xD;
            -  Palliative radiation treatment for ESCC within the past 4 weeks&#xD;
  &#xD;
            -  Participants with an esophageal/bronchial or esophageal/aorta fistula&#xD;
  &#xD;
            -  Prior treatment with programmed cell death protein-1 (PD-1) or other&#xD;
               immune-oncological drugs&#xD;
  &#xD;
          Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Study Director</last_name>
      <role>Study Director</role>
      <affiliation>BeiGene</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Director</last_name>
      <phone>1.877.828.5568</phone>
      <email>clinicaltrials@beigene.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</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>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tislelizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</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/NCT06010303
  org study id: BGB-A317-LBL-007-202
  nct id: NCT06010303
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a randomized, open-label study to compare how well LBL-007 works in combination with
        tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the
        first-line treatment in participants with inoperable locally advanced or metastatic
        esophageal squamous cell carcinoma (ESCC).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall Response Rate (ORR)
  time frame: Approximately 14 months
  description: Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
  measure: Progression Free Survival (PFS)
  time frame: Approximately 14 months
  description: Time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
  measure: Duration of Response (DOR)
  time frame: Approximately 14 months
  description: Time from the first determination of an overall response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
  measure: Disease Control Rate (DCR)
  time frame: Approximately 14 months
  description: Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Approximately 14 months
  description: Number of participants with AEs, including findings from physical examinations, electrocardiograms, and laboratory assessments according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
  arm group label: LBL-007
  arm group type: Experimental
  description: LBL-007 in combination with tislelizumab plus chemotherapy doublet.
  arm group label: Tislelizumab and Chemotherapy
  arm group type: Active Comparator
  description: Tislelizumab plus chemotherapy doublet.
  intervention type: Drug
  intervention name: LBL-007
  description: LBL-007 will be administered at a standard dose intravenously.
  arm group label: LBL-007
  intervention type: Drug
  intervention name: Tislelizumab
  description: Tislelizumab will be administered at a standard dose intravenously.
  arm group label: LBL-007
  arm group label: Tislelizumab and Chemotherapy
  other name: BGB-A317
  intervention type: Drug
  intervention name: Chemotherapy Doublet
  description: Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel
  Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.
  arm group label: LBL-007
  arm group label: Tislelizumab and Chemotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Study Director
  role: Study Director
  affiliation: BeiGene
  last name: Study Director
  phone: 1.877.828.5568
  email: clinicaltrials@beigene.com
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Esophageal Squamous Cell Carcinoma
  mesh term: Tislelizumab
  sharing ipd: Yes