<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/NCT03288870</url>
  </required_header>
  <id_info>
    <org_study_id>BCD-100-2/DOMINUS</org_study_id>
    <nct_id>NCT03288870</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)</brief_title>
  <acronym>DOMINUS</acronym>
  <official_title>International Multi-center Open-label Randomized Clinical Trial of Efficacy, Safety and Pharmacokinetics of BCD-100 (JSC &quot;BIOCAD&quot;, Russia) Monotherapy Compared to Docetaxel as Second-line Therapy of Patients With Advanced Inoperable or Metastatic Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biocad</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biocad</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      International multi-center open-label randomized clinical trial of efficacy, safety and&#xD;
      pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as&#xD;
      second-line therapy of patients with advanced inoperable or metastatic non-small cell lung&#xD;
      cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Anticipated">August 10, 2021</completion_date>
  <primary_completion_date type="Actual">August 10, 2020</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
    <description>Percent of patients who are alive after 1 year of therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>1 year</time_frame>
    <description>Percent of patients who have complete or partial response to therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Percent of patients who are alive after 1 year of therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">218</enrollment>
  <condition>Non Small Cell Lung Cancer Stage IIIB</condition>
  <condition>Non-Small Cell Carcinoma of Lung, TNM Stage 4</condition>
  <arm_group>
    <arm_group_label>BCD-100 monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive solution of BCD-100 in a dose 3 mg/kg every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Docetaxel monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive solution of docetaxel in a dose 75 mg per square meter every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity, maximum 6 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BCD-100</intervention_name>
    <description>monoclonal antibody to PD-1 receptor</description>
    <arm_group_label>BCD-100 monotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Chemotherapy drug (taxane)</description>
    <arm_group_label>Docetaxel monotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Verified diagnosis of non-small cell lung cancer&#xD;
&#xD;
          -  Verified progression of the disease after or during first-line chemotherapy based on&#xD;
             platinum drugs&#xD;
&#xD;
          -  Absence of mutation of EGFR and ALK genes&#xD;
&#xD;
          -  ECOG score 0-1&#xD;
&#xD;
          -  At least one lesion, that is measurable according to RECIST 1.1 criteria&#xD;
&#xD;
          -  Absence of severe organ pathology&#xD;
&#xD;
          -  Anticipated live duration more that 12 weeks after screening&#xD;
&#xD;
          -  Brain metastases with clinical symptoms requiring glucocorticoids and/or&#xD;
             anticonvulsant drugs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  EGFR and/or ALK mutations&#xD;
&#xD;
          -  Patients with severe of live-threatening acute complications of the disease&#xD;
&#xD;
          -  Intersticial lung diseases or pneumonitis&#xD;
&#xD;
          -  Concomitant diseases that affect safety evaluation&#xD;
&#xD;
          -  Autoimmune diseases&#xD;
&#xD;
          -  Endocrine diseases that could not be compensated by hormonal therapy&#xD;
&#xD;
          -  Patient needs glucocorticoids&#xD;
&#xD;
          -  Significant liver or renal diseases&#xD;
&#xD;
          -  Lactate dehydrogenase exceeds upper limit of normal more that 2-fold&#xD;
&#xD;
          -  More that 1 chemotherapy lines for advanced/metastatic non-small cell lung cancer&#xD;
             treatment&#xD;
&#xD;
          -  Anti-tumor treatment ending less then 28 days before screening&#xD;
&#xD;
          -  Prior therapy with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 drugs&#xD;
&#xD;
          -  Prior therapy with docetaxel&#xD;
&#xD;
          -  Concomitant oncological diseases except treated cervical carcinoma in situ or&#xD;
             radically resected squamous-cell carcinoma&#xD;
&#xD;
          -  Allergy to drugs based on monoclonal antibodies or docetaxel or polysorbate 80, severe&#xD;
             reactions to paclitaxel&#xD;
&#xD;
          -  Pregnancy and lactation&#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>Roman A Ivanov, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Vice President R&amp;D, JSC BIOCAD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gomel Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Gomel</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkhangelsk District Clinical Oncology Dispensary</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Oncology Dispensary N1</name>
      <address>
        <city>Krasnodar</city>
        <zip>350040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.N. Burdenko General Military Clinical Hospital</name>
      <address>
        <city>Moscow</city>
        <zip>105229</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pyatigorsk Oncology Center</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357502</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg City Clinical Oncology Center</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.N.Petrov Oncology Research Center</name>
      <address>
        <city>St.Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan</name>
      <address>
        <city>Ufa</city>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belarus</country>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</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>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>
  <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/NCT03288870
org study id: BCD-100-2/DOMINUS
nct id: NCT03288870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
International multi-center open-label randomized clinical trial of efficacy, safety and
      pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as
      second-line therapy of patients with advanced inoperable or metastatic non-small cell lung
      cancer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Overall survival
time frame: 1 year
description: Percent of patients who are alive after 1 year of therapy
measure: Overall response rate
time frame: 1 year
description: Percent of patients who have complete or partial response to therapy
measure: Progression-free survival
time frame: 1 year
description: Percent of patients who are alive after 1 year of therapy
arm group label: BCD-100 monotherapy
arm group type: Experimental
description: Patients will receive solution of BCD-100 in a dose 3 mg/kg every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity
arm group label: Docetaxel monotherapy
arm group type: Active Comparator
description: Patients will receive solution of docetaxel in a dose 75 mg per square meter every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity, maximum 6 cycles
intervention type: Drug
intervention name: BCD-100
description: monoclonal antibody to PD-1 receptor
arm group label: BCD-100 monotherapy
intervention type: Drug
intervention name: Docetaxel
description: Chemotherapy drug (taxane)
arm group label: Docetaxel monotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roman A Ivanov, PhD
role: Study Director
affiliation: Vice President R&D, JSC BIOCAD
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belarus
country: Russian Federation
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel
sharing ipd: No