<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/NCT04466917</url>
  </required_header>
  <id_info>
    <org_study_id>20180085</org_study_id>
    <nct_id>NCT04466917</nct_id>
  </id_info>
  <brief_title>A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to assess the efficacy and safety of ABP 215 compared&#xD;
      to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This&#xD;
      study consists of a screening period of up to 28 days, followed by a treatment period of 18&#xD;
      weeks, and an end of study visit 3 weeks after the last dose of investigational product or&#xD;
      study-specified chemotherapy. After randomization, subjects will receive investigational&#xD;
      product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4&#xD;
      and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor decision to early terminate the study&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 15, 2021</start_date>
  <completion_date type="Anticipated">November 13, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 13, 2022</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Subjects will be randomized to receive ABP 215 or bevacizumab on a 1:1 basis. All subjects will receive chemotherapy, following administration of investigational product.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Subjects, Amgen, designated PAREXEL, and other clinical site staff will be blinded to the investigational product allocation for each subject.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>From Day 1 to Week 19 (EOS)</time_frame>
    <description>The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>From Day 1 to Week 19 (EOS)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>From Day 1 to Week 19 (EOS)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC)</measure>
    <time_frame>Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum observed concentration (Cmin)</measure>
    <time_frame>Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-emergent adverse events</measure>
    <time_frame>From Screening to Week 19 (EOS)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-emergent events of interest (EOIs)</measure>
    <time_frame>From Screening to Week 19 (EOS)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with incidence of anti-drug antibodies (ADAs)</measure>
    <time_frame>On Week 1, Week 7, Week 13 and Week 19 (EOS)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Metastatic Non-small Cell Lung Cancer (NSCLC)</condition>
  <condition>Non-squamous NSCLC</condition>
  <arm_group>
    <arm_group_label>ABP 215</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles.&#xD;
All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bevacizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles.&#xD;
All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABP 215</intervention_name>
    <description>ABP 215 will be administered at a dose of 15 mg/kg IV</description>
    <arm_group_label>ABP 215</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab will be administered at a dose of 15 mg/kg IV</description>
    <arm_group_label>Bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel will be administered 175 mg/m2 IV</description>
    <arm_group_label>ABP 215</arm_group_label>
    <arm_group_label>Bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV</description>
    <arm_group_label>ABP 215</arm_group_label>
    <arm_group_label>Bevacizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed non-squamous NSCLC.&#xD;
&#xD;
          -  Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8&#xD;
             days after randomization and expected to receive at least 4 and no more than 6 cycles&#xD;
             of chemotherapy.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.&#xD;
&#xD;
          -  Other inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Small cell lung cancer (SCLC) or mixed SCLC and NSCLC.&#xD;
&#xD;
          -  Central nervous system (CNS) metastases.&#xD;
&#xD;
          -  Malignancy other than NSCLC.&#xD;
&#xD;
          -  Palliative radiotherapy for bone lesions inside the thorax.&#xD;
&#xD;
          -  Prior radiotherapy of bone marrow.&#xD;
&#xD;
          -  Active hepatitis B.&#xD;
&#xD;
          -  Active hepatitis C.&#xD;
&#xD;
          -  Tested positive for human immunodeficiency virus (HIV).&#xD;
&#xD;
          -  Life expectancy &lt; 6 months.&#xD;
&#xD;
          -  Woman of childbearing potential who is pregnant or is breast feeding.&#xD;
&#xD;
          -  Woman of childbearing potential who is not consenting to use highly effective methods&#xD;
             of birth control during treatment and for an additional 6 months after the last&#xD;
             administration of the protocol specified treatment.&#xD;
&#xD;
          -  Man with a partner of childbearing potential who does not consent to use highly&#xD;
             effective methods of birth control during treatment and for an additional 6 months&#xD;
             after the last administration of the protocol specified treatment.&#xD;
&#xD;
          -  Other exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biosimilar</keyword>
  <keyword>Bevacizumab</keyword>
  <keyword>Carboplatin</keyword>
  <keyword>Paclitaxel</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>Paclitaxel</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04466917
org study id: 20180085
nct id: NCT04466917
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this research study is to assess the efficacy and safety of ABP 215 compared
      to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).
Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This
      study consists of a screening period of up to 28 days, followed by a treatment period of 18
      weeks, and an end of study visit 3 weeks after the last dose of investigational product or
      study-specified chemotherapy. After randomization, subjects will receive investigational
      product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4
      and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to receive ABP 215 or bevacizumab on a 1:1 basis. All subjects will receive chemotherapy, following administration of investigational product.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Subjects, Amgen, designated PAREXEL, and other clinical site staff will be blinded to the investigational product allocation for each subject.
measure: Objective response rate (ORR)
time frame: From Day 1 to Week 19 (EOS)
description: The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR).
measure: Progression-free survival (PFS)
time frame: From Day 1 to Week 19 (EOS)
measure: Duration of response (DOR)
time frame: From Day 1 to Week 19 (EOS)
measure: Maximum Plasma Concentration (Cmax)
time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
measure: Area Under the Curve (AUC)
time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
measure: Minimum observed concentration (Cmin)
time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
measure: Number of participants with treatment-emergent adverse events
time frame: From Screening to Week 19 (EOS)
measure: Number of participants with treatment-emergent events of interest (EOIs)
time frame: From Screening to Week 19 (EOS)
measure: Number of participants with incidence of anti-drug antibodies (ADAs)
time frame: On Week 1, Week 7, Week 13 and Week 19 (EOS)
arm group label: ABP 215
arm group type: Experimental
description: Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.
arm group label: Bevacizumab
arm group type: Active Comparator
description: Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.
intervention type: Drug
intervention name: ABP 215
description: ABP 215 will be administered at a dose of 15 mg/kg IV
arm group label: ABP 215
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab will be administered at a dose of 15 mg/kg IV
arm group label: Bevacizumab
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel will be administered 175 mg/m2 IV
arm group label: ABP 215
arm group label: Bevacizumab
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV
arm group label: ABP 215
arm group label: Bevacizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Bevacizumab
mesh term: Carboplatin
sharing ipd: No