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/NCT06029127</url>
    </required_header>
    <id_info>
      <org_study_id>BGB-LC-203</org_study_id>
      <nct_id>NCT06029127</nct_id>
    </id_info>
    <brief_title>A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer</brief_title>
    <official_title>A Phase 2, Open-label, Randomized, Multi-arm Study of BGB-A445 in Combination With Investigational Agents in Non-Small Cell Lung Cancer Patients Previously Treated With Anti-PD-(L)1 Antibody</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BeiGene</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>BeiGene</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 main objective of this study is to evaluate the anti-tumor activity of BGB-A445 plus&#xD;
        investigational agents in participants with non-small cell lung cancer (NSCLC)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will test whether BGB-A445 in combination with other agents can help treat&#xD;
        participants with non-small cell lung cancer (NSCLC) who were already treated with other&#xD;
        anticancer agents, including anti-programmed cell death protein-1 (anti-PD-1) and&#xD;
        anti-programmed cell death protein ligand-1 (anti-PD-L1) antibodies. The main goal of this&#xD;
        study is to see if BGB-A445 can increase participant response to treatment, also called the&#xD;
        overall response rate Only a portion of patients with advanced solid tumors have a durable&#xD;
        response to currently available treatments. This represents an unmet medical need to develop&#xD;
        improved therapeutic options. Combining targeted vascular therapies with immunotherapies&#xD;
        might improve outcomes for these patients.&#xD;
  &#xD;
        This study is designed as a proof of concept to show that BGB-A445-based combination&#xD;
        treatment may be able to improve responses and clinical benefit in patients with NSCLC. Stage&#xD;
        1 of the study will take place in China and the Asia Pacific region and Stage 2 will be&#xD;
        expanded to take place worldwide. The overall time to participate in this study is&#xD;
        approximately 3 years. Treatments will continue until participants experience no benefits,&#xD;
        too many side effects, or withdraw consent.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2026</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</measure>
      <time_frame>Up to Approximately 3 years</time_frame>
      <description>Overall response rate (ORR) is defined as the percentage of participants with best overall response (BOR) of a complete response (CR) or partial response (PRas assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1. ).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
      <time_frame>Up to Approximately 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Up to Approximately 3 years</time_frame>
      <description>DOR is defined as the time from the first determination of an objective response as assessed by the investigator per RECIST v1 until the first documentation of progression or death, whichever comes first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>Up to Approximately 3 years</time_frame>
      <description>DCR is defined as the percentage of participants with BOR of a CR, PR, or stable disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Benefit Rate (CBR)</measure>
      <time_frame>Up to Approximately 3 years</time_frame>
      <description>CBR is defined as the percentage of participants with BOR of a CR, PR, or stable disease lasting ≥ 24 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>Up to Approximately 3 years</time_frame>
      <description>PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Up to Approximately 3 years</time_frame>
      <description>OS is defined as the time from the date of randomization to the date of death due to any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma and Serum Concentrations of BGB-A445 and Investigational Agents</measure>
      <time_frame>Days 1, 8, and 15 of Cycle 1 and days 1 and 8 of Cycle 2, and Day 1 of all subsequent Cycles and End of Study Visit - Up to approximately 3 years (each cycle 21 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Ant-Drug Antibodies to BGB-A445 and Investigational Agents</measure>
      <time_frame>Up to Approximately 3 years</time_frame>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Non-Small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Stage 1: BGB-A445 + Docetaxel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BGB-A445 + Docetaxel</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Stage 1: BGB-A445 + Tislelizumab + Sitravatinib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BGB-A445 + tislelizumab + Sitravatinib</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Stage 1: BGB-A445 + BGB-15025</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BGB-A445 + BGB-15025</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BGB-A445 + selected investigational agent(s) from Stage 1 (either Docetaxel, Tislelizumab + Sitravatinib or BGB-15025)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Docetaxel + Ramucirumab</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Reference to Stage 2: Ramucirumab + Docetaxel</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BGB-A445</intervention_name>
      <description>Administered intravenously at protocol defined dose</description>
      <arm_group_label>Stage 1: BGB-A445 + BGB-15025</arm_group_label>
      <arm_group_label>Stage 1: BGB-A445 + Docetaxel</arm_group_label>
      <arm_group_label>Stage 1: BGB-A445 + Tislelizumab + Sitravatinib</arm_group_label>
      <arm_group_label>Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Docetaxel</intervention_name>
      <description>75 milligrams per square meter (mg/m^2) administered intravenously</description>
      <arm_group_label>Docetaxel + Ramucirumab</arm_group_label>
      <arm_group_label>Stage 1: BGB-A445 + Docetaxel</arm_group_label>
      <arm_group_label>Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tislelizumab</intervention_name>
      <description>Administered intravenously at protocol defined dose</description>
      <arm_group_label>Stage 1: BGB-A445 + Tislelizumab + Sitravatinib</arm_group_label>
      <arm_group_label>Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1</arm_group_label>
      <other_name>BGB-A317</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sitravatinib</intervention_name>
      <description>Administered orally at protocol defined dose</description>
      <arm_group_label>Stage 1: BGB-A445 + Tislelizumab + Sitravatinib</arm_group_label>
      <arm_group_label>Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ramucirumab</intervention_name>
      <description>10 mg/kg administered intravenously</description>
      <arm_group_label>Docetaxel + Ramucirumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Selected Interventions</intervention_name>
      <description>Administered at protocol defined dose</description>
      <arm_group_label>Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BGB-15025</intervention_name>
      <description>Administered orally at protocol defined dose</description>
      <arm_group_label>Stage 1: BGB-A445 + BGB-15025</arm_group_label>
      <arm_group_label>Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Advanced or metastatic NSCLC (nonsquamous or squamous) that is histologically or&#xD;
               cytologically confirmed&#xD;
  &#xD;
            -  Participants who have received no more than 2 lines of prior systemic therapies which&#xD;
               must include anti-programmed cell death protein ligand-1 (anti-PD-L1) anti-PD-(L)1&#xD;
               treatment&#xD;
  &#xD;
            -  At least 1 measurable lesion as defined per RECIST v1.1&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1&#xD;
  &#xD;
            -  Adequate organ function as indicated by laboratory values during screening&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  With mixed small cell lung cancer&#xD;
  &#xD;
            -  Has received prior therapy targeting OX40 or any other T-cell agonists&#xD;
  &#xD;
            -  Has received prior therapy containing docetaxel and/or ramucirumab for advanced or&#xD;
               metastatic NSCLC&#xD;
  &#xD;
            -  Has received any Chinese herbal medicine or Chinese patent medicines used to control&#xD;
               cancer ≤ 14 days before the first dose of study drug(s)&#xD;
  &#xD;
            -  Active leptomeningeal disease or uncontrolled and untreated brain metastasis&#xD;
  &#xD;
          NOTE: Other 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_contact>
      <last_name>Study Director</last_name>
      <phone>1-877-828-5568</phone>
      <email>clinicaltrials@beigene.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PD-L1</keyword>
    <keyword>NSCLC</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>
      <mesh_term>Tislelizumab</mesh_term>
      <mesh_term>Ramucirumab</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06029127
  org study id: BGB-LC-203
  nct id: NCT06029127
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of this study is to evaluate the anti-tumor activity of BGB-A445 plus
        investigational agents in participants with non-small cell lung cancer (NSCLC)
  This study will test whether BGB-A445 in combination with other agents can help treat
        participants with non-small cell lung cancer (NSCLC) who were already treated with other
        anticancer agents, including anti-programmed cell death protein-1 (anti-PD-1) and
        anti-programmed cell death protein ligand-1 (anti-PD-L1) antibodies. The main goal of this
        study is to see if BGB-A445 can increase participant response to treatment, also called the
        overall response rate Only a portion of patients with advanced solid tumors have a durable
        response to currently available treatments. This represents an unmet medical need to develop
        improved therapeutic options. Combining targeted vascular therapies with immunotherapies
        might improve outcomes for these patients.
  
        This study is designed as a proof of concept to show that BGB-A445-based combination
        treatment may be able to improve responses and clinical benefit in patients with NSCLC. Stage
        1 of the study will take place in China and the Asia Pacific region and Stage 2 will be
        expanded to take place worldwide. The overall time to participate in this study is
        approximately 3 years. Treatments will continue until participants experience no benefits,
        too many side effects, or withdraw consent.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall Response Rate
  time frame: Up to Approximately 3 years
  description: Overall response rate (ORR) is defined as the percentage of participants with best overall response (BOR) of a complete response (CR) or partial response (PRas assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1. ).
  measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
  time frame: Up to Approximately 3 years
  measure: Duration of Response (DOR)
  time frame: Up to Approximately 3 years
  description: DOR is defined as the time from the first determination of an objective response as assessed by the investigator per RECIST v1 until the first documentation of progression or death, whichever comes first
  measure: Disease Control Rate (DCR)
  time frame: Up to Approximately 3 years
  description: DCR is defined as the percentage of participants with BOR of a CR, PR, or stable disease.
  measure: Clinical Benefit Rate (CBR)
  time frame: Up to Approximately 3 years
  description: CBR is defined as the percentage of participants with BOR of a CR, PR, or stable disease lasting ≥ 24 weeks
  measure: Progression Free Survival (PFS)
  time frame: Up to Approximately 3 years
  description: PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first
  measure: Overall Survival (OS)
  time frame: Up to Approximately 3 years
  description: OS is defined as the time from the date of randomization to the date of death due to any cause
  measure: Plasma and Serum Concentrations of BGB-A445 and Investigational Agents
  time frame: Days 1, 8, and 15 of Cycle 1 and days 1 and 8 of Cycle 2, and Day 1 of all subsequent Cycles and End of Study Visit - Up to approximately 3 years (each cycle 21 days)
  measure: Number of participants with Ant-Drug Antibodies to BGB-A445 and Investigational Agents
  time frame: Up to Approximately 3 years
  arm group label: Stage 1: BGB-A445 + Docetaxel
  arm group type: Experimental
  description: BGB-A445 + Docetaxel
  arm group label: Stage 1: BGB-A445 + Tislelizumab + Sitravatinib
  arm group type: Experimental
  description: BGB-A445 + tislelizumab + Sitravatinib
  arm group label: Stage 1: BGB-A445 + BGB-15025
  arm group type: Experimental
  description: BGB-A445 + BGB-15025
  arm group label: Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1
  arm group type: Experimental
  description: BGB-A445 + selected investigational agent(s) from Stage 1 (either Docetaxel, Tislelizumab + Sitravatinib or BGB-15025)
  arm group label: Docetaxel + Ramucirumab
  arm group type: Other
  description: Reference to Stage 2: Ramucirumab + Docetaxel
  intervention type: Drug
  intervention name: BGB-A445
  description: Administered intravenously at protocol defined dose
  arm group label: Stage 1: BGB-A445 + BGB-15025
  arm group label: Stage 1: BGB-A445 + Docetaxel
  arm group label: Stage 1: BGB-A445 + Tislelizumab + Sitravatinib
  arm group label: Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1
  intervention type: Drug
  intervention name: Docetaxel
  description: 75 milligrams per square meter (mg/m^2) administered intravenously
  arm group label: Docetaxel + Ramucirumab
  arm group label: Stage 1: BGB-A445 + Docetaxel
  arm group label: Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1
  intervention type: Drug
  intervention name: Tislelizumab
  description: Administered intravenously at protocol defined dose
  arm group label: Stage 1: BGB-A445 + Tislelizumab + Sitravatinib
  arm group label: Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1
  other name: BGB-A317
  intervention type: Drug
  intervention name: Sitravatinib
  description: Administered orally at protocol defined dose
  arm group label: Stage 1: BGB-A445 + Tislelizumab + Sitravatinib
  arm group label: Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1
  intervention type: Drug
  intervention name: Ramucirumab
  description: 10 mg/kg administered intravenously
  arm group label: Docetaxel + Ramucirumab
  intervention type: Drug
  intervention name: Selected Interventions
  description: Administered at protocol defined dose
  arm group label: Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1
  intervention type: Drug
  intervention name: BGB-15025
  description: Administered orally at protocol defined dose
  arm group label: Stage 1: BGB-A445 + BGB-15025
  arm group label: Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Study Director
  phone: 1-877-828-5568
  email: clinicaltrials@beigene.com
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Docetaxel
  mesh term: Tislelizumab
  mesh term: Ramucirumab