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/NCT06010329</url>
    </required_header>
    <id_info>
      <org_study_id>TL-EGFR-2201</org_study_id>
      <nct_id>NCT06010329</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC</brief_title>
    <official_title>A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Teligene US</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Teligene US</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main objective of the study will be to evaluate the efficacy of sutetinib maleate&#xD;
        capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC&#xD;
        (uncommon EGFR mutations only).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene&#xD;
        that makes a protein that is involved in cell growth and cell survival. Mutated (changed)&#xD;
        forms of the EGFR gene and protein have been found in some types of cancer, including&#xD;
        non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the&#xD;
        body. The purpose of this study is to explore how effective Sutetinib maleate capsules are&#xD;
        for the treatment of patients with locally advanced or metastatic NSCLC with non-resistant&#xD;
        uncommon EGFR mutations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 29, 2023</start_date>
    <completion_date type="Anticipated">May 25, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 25, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective Response Rate (ORR)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Tumor Progression (TTP)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Response (TTR)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Treatment Failure (TTF)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year Progression Free Survival</measure>
      <time_frame>Pre-dose up to 1 year post-dose</time_frame>
      <description>Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year Survival</measure>
      <time_frame>Pre-dose up to 1 year post-dose</time_frame>
      <description>Ratio of surviving participants 1 year after the first dose of IP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under The Curve (AUC) of Sutetinib Maleate Capsule</measure>
      <time_frame>Pre-dose up to 24 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule</measure>
      <time_frame>Pre-dose up to 24 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule</measure>
      <time_frame>Pre-dose up to 24 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule</measure>
      <time_frame>Pre-dose up to 24 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sutetinib Maleate Capsule half-life (T1/2)</measure>
      <time_frame>Pre-dose up to 24 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Clearance (CL/f) of Sutetinib Maleate Capsule</measure>
      <time_frame>Pre-dose up to 24 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule</measure>
      <time_frame>Pre-dose up to 24 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Adverse Events (AE)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Adverse Drug Reactions (ADR)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Serious Adverse Events (SAE)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Srious Adverse Reactions (SAR)</measure>
      <time_frame>Pre-dose up to approximately 20 months post-dose</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Non-small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Single arm, Open label</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, 80 mg once daily, 28 days for a cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sutetinib Maleate Capsule</intervention_name>
      <description>Oral administration</description>
      <arm_group_label>Single arm, Open label</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 years old and above, male or female&#xD;
  &#xD;
            2. Histopathological and/or cytopathological confirmation of locally advanced or&#xD;
               metastatic NSCLC&#xD;
  &#xD;
            3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor&#xD;
               (EGFR) mutation (tumor tissue biopsy)&#xD;
  &#xD;
            4. At least one measurable lesion&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2&#xD;
  &#xD;
            6. A minimum life expectancy of &gt; 3 months&#xD;
  &#xD;
            7. Adequate bone marrow reserve, hepatic, renal, and coagulation function&#xD;
  &#xD;
          Other inclusion criteria apply for participating in the Study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor&#xD;
               (EGFR-TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation&#xD;
               EGFR TKI (Cohort 2)&#xD;
  &#xD;
            2. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including&#xD;
               curative radiotherapy or spinal radiotherapy portion &gt;30%) used within 3 weeks prior&#xD;
               to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for&#xD;
               non-target lesions used to relieve symptoms and traditional Chinese medicines&#xD;
               indicated for the tumor within 2 weeks prior to enrollment&#xD;
  &#xD;
            3. Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome&#xD;
               P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer,&#xD;
               prior to enrollment&#xD;
  &#xD;
            4. Surgical operation (excluding aspiration biopsy) of main organs or a significant&#xD;
               injury within 4 weeks prior to enrollment&#xD;
  &#xD;
            5. Any unresolved toxicities from prior therapy greater than Grade 1, at the time of&#xD;
               screening except for alopecia&#xD;
  &#xD;
            6. Inability to swallow the study medication, any seriously chronic gastrointestinal&#xD;
               disorder, malabsorption syndrome or any other conditions with influence on&#xD;
               gastrointestinal absorption&#xD;
  &#xD;
            7. Active central nervous system metastases&#xD;
  &#xD;
            8. Any active infection which has not been controlled at screening.&#xD;
  &#xD;
          Other exclusion criteria apply for participating in the Study&#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>Xiaoyang Xia</last_name>
      <phone>805-300-9373</phone>
      <email>Xiaoyang.xia@teligene.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dawei Zhang</last_name>
      <phone>805-300-1019</phone>
      <email>david.zhang@teligene.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 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>
    <keyword>Oncology</keyword>
    <keyword>Sutetinib Maleate Capsule</keyword>
    <keyword>Teligene</keyword>
    <keyword>Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>Maleic acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06010329
  org study id: TL-EGFR-2201
  nct id: NCT06010329
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The main objective of the study will be to evaluate the efficacy of sutetinib maleate
        capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC
        (uncommon EGFR mutations only).
  Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene
        that makes a protein that is involved in cell growth and cell survival. Mutated (changed)
        forms of the EGFR gene and protein have been found in some types of cancer, including
        non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the
        body. The purpose of this study is to explore how effective Sutetinib maleate capsules are
        for the treatment of patients with locally advanced or metastatic NSCLC with non-resistant
        uncommon EGFR mutations.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response Rate (ORR)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Duration of Response (DoR)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Disease Control Rate (DCR)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Progression Free Survival (PFS)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Time to Tumor Progression (TTP)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Time to Response (TTR)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Time to Treatment Failure (TTF)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Overall Survival (OS)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: 1-year Progression Free Survival
  time frame: Pre-dose up to 1 year post-dose
  description: Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP.
  measure: 1-year Survival
  time frame: Pre-dose up to 1 year post-dose
  description: Ratio of surviving participants 1 year after the first dose of IP.
  measure: Area Under The Curve (AUC) of Sutetinib Maleate Capsule
  time frame: Pre-dose up to 24 hours post-dose
  measure: Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule
  time frame: Pre-dose up to 24 hours post-dose
  measure: Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule
  time frame: Pre-dose up to 24 hours post-dose
  measure: Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule
  time frame: Pre-dose up to 24 hours post-dose
  measure: Sutetinib Maleate Capsule half-life (T1/2)
  time frame: Pre-dose up to 24 hours post-dose
  measure: Apparent Clearance (CL/f) of Sutetinib Maleate Capsule
  time frame: Pre-dose up to 24 hours post-dose
  measure: Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule
  time frame: Pre-dose up to 24 hours post-dose
  measure: Number of Participants Experiencing Adverse Events (AE)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Number of Participants Experiencing Adverse Drug Reactions (ADR)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Number of Participants Experiencing Serious Adverse Events (SAE)
  time frame: Pre-dose up to approximately 20 months post-dose
  measure: Number of Participants Experiencing Srious Adverse Reactions (SAR)
  time frame: Pre-dose up to approximately 20 months post-dose
  arm group label: Single arm, Open label
  arm group type: Experimental
  description: Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, 80 mg once daily, 28 days for a cycle.
  intervention type: Drug
  intervention name: Sutetinib Maleate Capsule
  description: Oral administration
  arm group label: Single arm, Open label
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xiaoyang Xia
  phone: 805-300-9373
  email: Xiaoyang.xia@teligene.com
  last name: Dawei Zhang
  phone: 805-300-1019
  email: david.zhang@teligene.com
  responsible party type: Sponsor
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Maleic acid
  sharing ipd: No