<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/NCT04474119</url>
  </required_header>
  <id_info>
    <org_study_id>KN046-301</org_study_id>
    <nct_id>NCT04474119</nct_id>
  </id_info>
  <brief_title>KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Platinum-containing Chemotherapy Versus Placebo Combined With Platinum-containing Chemotherapy in First Line Advanced Squamous Non-small Cell Lung Cancer Subjects (ENREACH-L-01)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Alphamab Biopharmaceuticals Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Alphamab Biopharmaceuticals Co., Ltd</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>
      This study is a randomized, double-blind, multicenter, phase III clinical study to compare&#xD;
      the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus&#xD;
      paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously&#xD;
      received systemic treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging</measure>
    <time_frame>up to 2 years</time_frame>
    <description>PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigators</measure>
    <time_frame>up to 2 years</time_frame>
    <description>PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">482</enrollment>
  <condition>Squamous Non-small-cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KN046 plus Carboplatin and Paclitaxel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo plus Carboplatin and Paclitaxel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KN046</intervention_name>
    <description>In combine therapy stage, KN046 is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.</description>
    <arm_group_label>Experimental arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KN046 placebo</intervention_name>
    <description>In combine therapy stage, KN046 placebo is 5 milligram per kilogram, every 3 weeks.&#xD;
In maintain stage, KN046 placebo is 5 milligram per kilogram, every 2 weeks.</description>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV&#xD;
             squamous NSCLC.&#xD;
&#xD;
          -  No known epidermal growth factor receptor (EGFR) mutations.&#xD;
&#xD;
          -  Has measurable disease.&#xD;
&#xD;
          -  Has not received prior systemic treatment for their advanced/metastatic NSCLC.&#xD;
&#xD;
          -  Can provide tumor tissue.&#xD;
&#xD;
          -  Has a life expectancy of at least 3 months.&#xD;
&#xD;
          -  Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)&#xD;
             Performance Status.&#xD;
&#xD;
          -  Has adequate organ function&#xD;
&#xD;
          -  If female of childbearing potential, have a negative serum pregnancy test within 7&#xD;
             days prior to first trial treatment;&#xD;
&#xD;
          -  If female of childbearing potential or a male subject with a partner with childbearing&#xD;
             potential, be willing to use a highly effective method of contraception (with a&#xD;
             failure rate of less than 1.0% per year) from first study treatment to 24 weeks after&#xD;
             completion of the trial treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated active CNS metastasis or leptomeningeal metastasis.&#xD;
&#xD;
          -  Is currently participating and receiving an investigational drug or has participated&#xD;
             in a study of an investigational drug within 4 weeks or within 5 times of half-life&#xD;
             (no less than 2 weeks), whichever is shorter prior to the first dose of trial&#xD;
             treatment;&#xD;
&#xD;
          -  Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life&#xD;
             (no less than 2 weeks), whichever is shorter prior to the first trial treatment;&#xD;
&#xD;
          -  Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first&#xD;
             administration of trial treatment and/or if the subject has not fully recovered from&#xD;
             the surgery within 4 weeks of the first administration of trial treatment;&#xD;
&#xD;
          -  Curative radiation within 3 months of the first dose of trial treatment. Radiation to&#xD;
             more than 30% of the bone marrow or with a wide field of radiation should not be used&#xD;
             within 4 weeks prior to the first administration of trial treatment;&#xD;
&#xD;
          -  Subjects receiving immunosuppressive agents (such as steroids) for any reason should&#xD;
             be tapered off these drugs before initiation of trial treatment (with the exception of&#xD;
             subjects with adrenal insufficiency, who may continue corticosteroids at physiologic&#xD;
             replacement doses, equivalent to &lt; 10 mg prednisone daily, inhaled steroids and&#xD;
             topical use of steroids);&#xD;
&#xD;
          -  Vaccination within 28 days of the first administration of trial treatment, except for&#xD;
             administration of inactivated vaccines (e.g., inactivated influenza vaccines);&#xD;
&#xD;
          -  Has interstitial lung disease, or a history of pneumonitis that required oral or&#xD;
             intravenous glucocorticoids to assist with management;&#xD;
&#xD;
          -  History or current active autoimmune disease that might deteriorate when receiving an&#xD;
             immunostimulatory agent&#xD;
&#xD;
          -  Previous malignant disease&#xD;
&#xD;
          -  History of uncontrolled intercurrent illness&#xD;
&#xD;
          -  Prior therapy with any antibody/drug targeting T cell coregulatory proteins&#xD;
&#xD;
          -  Known severe hypersensitivity reactions to antibody drug&#xD;
&#xD;
          -  Is pregnant or breastfeeding;&#xD;
&#xD;
          -  Other medical conditions that at the discretion of investigator interfere with the&#xD;
             requirements of the trial in terms of safety or efficacy evaluation, or treatment&#xD;
             compliance.&#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>Caicun Zhou, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Pulmonary Hospital, Shanghai, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>November 16, 2021</last_update_submitted>
  <last_update_submitted_qc>November 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2021</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>
  <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/NCT04474119
org study id: KN046-301
nct id: NCT04474119
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a randomized, double-blind, multicenter, phase III clinical study to compare
      the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus
      paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously
      received systemic treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging
time frame: up to 2 years
description: PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
measure: Overall Survival (OS)
time frame: up to 3 years
description: OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up.
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigators
time frame: up to 2 years
description: PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
arm group label: Experimental arm
arm group type: Experimental
description: KN046 plus Carboplatin and Paclitaxel
arm group label: Control arm
arm group type: Placebo Comparator
description: Placebo plus Carboplatin and Paclitaxel
intervention type: Drug
intervention name: KN046
description: In combine therapy stage, KN046 is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.
arm group label: Experimental arm
intervention type: Drug
intervention name: KN046 placebo
description: In combine therapy stage, KN046 placebo is 5 milligram per kilogram, every 3 weeks.
In maintain stage, KN046 placebo is 5 milligram per kilogram, every 2 weeks.
arm group label: Control arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Caicun Zhou, MD, PhD
role: Principal Investigator
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No