<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/NCT03812809</url>
  </required_header>
  <id_info>
    <org_study_id>BPI-7711201</org_study_id>
    <nct_id>NCT03812809</nct_id>
  </id_info>
  <brief_title>A Phase IIb Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients With T790M Mutation Positive</brief_title>
  <official_title>A Phase IIb, Open-label, Single-arm Study to Assess the Safety and Efficacy of BPI-7711 Capsule in Patients With Metastatic or Recurrent Non-small Cell Lung Cancer With EGFR Mutation and T790M Mutation Positive.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beta Pharma Shanghai</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beta Pharma, Inc.</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>
      A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711&#xD;
      capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR&#xD;
      mutation and T790M mutation positive.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase IIb, open-label, single arm study assessing the safety and efficacy of&#xD;
      BPI-7711 (180 mg, orally, once daily) in China with a confirmed diagnosis of EGFR sensitizing&#xD;
      mutation positive and T790M mutation+ unresectable, locally advanced or metastatic NSCLC, who&#xD;
      have progressed on prior EGFR-TKIs treatment. The primary objective of the study is to assess&#xD;
      the efficacy of BPI-7711 by assessment of ORR according to RECIST 1.1 by an Independent&#xD;
      Central Review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2019</start_date>
  <completion_date type="Actual">January 24, 2022</completion_date>
  <primary_completion_date type="Actual">January 24, 2022</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>ORR according to RECIST 1.1 by an Independent Central Review (ICR)</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR according to RECIST 1.1 by investigators</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR) according to RECIST 1.1</measure>
    <time_frame>up to 104 weeks</time_frame>
    <description>DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival(PFS) according to RECIST 1.1</measure>
    <time_frame>up to 104 weeks</time_frame>
    <description>PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from BPI-7711 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">226</enrollment>
  <condition>NSCLC</condition>
  <arm_group>
    <arm_group_label>BPI-7711</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BPI-7711: 180mg, QD, oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BPI-7711</intervention_name>
    <description>BPI-7711: 180mg, QD, oral</description>
    <arm_group_label>BPI-7711</arm_group_label>
    <other_name>BPI-7711 capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged at least 18 years.&#xD;
&#xD;
          -  Locally advanced or metastatic NSCLC, not amenable to curative surgery or&#xD;
             radiotherapy.&#xD;
&#xD;
          -  Radiological documentation of disease progression after the most recent EGFR-TKI&#xD;
             treatment administered. Radiological documentation of disease progression after the&#xD;
             most recent treatment, or intolerant to current chemotherapy, or unwilling to accept&#xD;
             the current treatment.&#xD;
&#xD;
          -  At least one non-brain measurable lesion, not previously irradiated that can be&#xD;
             accurately measured at baseline. If only one measurable lesion, the baseline CT should&#xD;
             be performed before the biopsy or at least 14 days after the biopsy. Prior irradiated&#xD;
             lesion can only be used as biopsy lesion after significant progression.&#xD;
&#xD;
          -  Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to&#xD;
             be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R,&#xD;
             L861Q).&#xD;
&#xD;
          -  Patients must have central confirmation of tumor T790M mutation+ status from a biopsy&#xD;
             sample or a plasma sample taken after confirmation of disease progression on the most&#xD;
             recent EGFR-TKI treatment. Primary T790M mutation positive patients should provide&#xD;
             prior written evidence before ICF signature and have not received any EGFR-TKI.&#xD;
&#xD;
          -  ECOG performance status 0-1 with no deterioration over the previous 2 weeks and a&#xD;
             minimum life expectancy of 12 weeks.&#xD;
&#xD;
          -  Females of child-bearing potential using contraception and must have a negative&#xD;
             pregnancy test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed EGFR 20 exon insertion mutation after the initial diagnosis of NSCLC.&#xD;
&#xD;
          -  Treatment with any 1st or 2nd EGFR-TKI (eg, erlotinib, gefitinib, icotinib, afatinib&#xD;
             or dacomitinib) within 5x half-life of study entry.&#xD;
&#xD;
          -  Treatment with any 3rd generation EGFR TKIs target on T790M mutation.&#xD;
&#xD;
          -  Treatment with any cytotoxic chemotherapy, investigational agents, CYP3A4/CYP2C19&#xD;
             potent inhibitor/inducer, or other anticancer drugs within 14 days of study entry.&#xD;
&#xD;
          -  Prior medical history of interstitial lung disease, drug-induced interstitial lung&#xD;
             disease, radiation pneumonitis which required steroid treatment, or any evidence of&#xD;
             clinically active interstitial lung disease.&#xD;
&#xD;
          -  Spinal cord compression or brain metastases unless asymptomatic, stable, and not&#xD;
             requiring steroids for at least 4 weeks prior to study treatment.&#xD;
&#xD;
          -  Major surgery within 4 weeks of study entry; radiotherapy treatment to more than 30%&#xD;
             of the bone marrow or with a wide field of radiation within 4 weeks of study entry.&#xD;
&#xD;
          -  Refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.&#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>Yuankai Shi</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linyi Cancer Hospital</name>
      <address>
        <city>Linyi</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>May 13, 2022</last_update_submitted>
  <last_update_submitted_qc>May 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EGFR</keyword>
  <keyword>T790M</keyword>
  <keyword>NSCLC</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>
  <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/NCT03812809
org study id: BPI-7711201
nct id: NCT03812809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711
      capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR
      mutation and T790M mutation positive.
This is a phase IIb, open-label, single arm study assessing the safety and efficacy of
      BPI-7711 (180 mg, orally, once daily) in China with a confirmed diagnosis of EGFR sensitizing
      mutation positive and T790M mutation+ unresectable, locally advanced or metastatic NSCLC, who
      have progressed on prior EGFR-TKIs treatment. The primary objective of the study is to assess
      the efficacy of BPI-7711 by assessment of ORR according to RECIST 1.1 by an Independent
      Central Review.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ORR according to RECIST 1.1 by an Independent Central Review (ICR)
time frame: up to 52 weeks
description: Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
measure: ORR according to RECIST 1.1 by investigators
time frame: up to 52 weeks
description: Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
measure: Disease control rate (DCR) according to RECIST 1.1
time frame: up to 104 weeks
description: DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.
measure: Progression free survival(PFS) according to RECIST 1.1
time frame: up to 104 weeks
description: PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from BPI-7711 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
arm group label: BPI-7711
arm group type: Experimental
description: BPI-7711: 180mg, QD, oral
intervention type: Drug
intervention name: BPI-7711
description: BPI-7711: 180mg, QD, oral
arm group label: BPI-7711
other name: BPI-7711 capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuankai Shi
role: Principal Investigator
affiliation: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No