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/NCT05987826</url>
    </required_header>
    <id_info>
      <org_study_id>B2023-170R</org_study_id>
      <nct_id>NCT05987826</nct_id>
    </id_info>
    <brief_title>Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC</brief_title>
    <official_title>Furmonertinib Mesylate Neoadjuvant Treatment of Resectable Stage Ⅱ-ⅢB Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor（EGFR）Sensitive Mutation：a Prospective，Muliticenter，Open Label，Phase Ⅱ Single-arm Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Xuhui Central Hospital, Shanghai</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Minhang Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Zhongshan Hospital Qingpu Branch</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ningbo No. 1 Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shanghai Zhongshan Hospital</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>
        EGFR-TKI has firmly established itself as a first-line treatment for advanced lung cancer&#xD;
        with EGFR-sensitive mutations, and the ADAURA study has added to its indications for use as&#xD;
        postoperative adjuvant therapy in early- and mid-stage lung cancer.However, clinical data on&#xD;
        neoadjuvant EGFR-TKI therapy are still incomplete. A phase II clinical study, CTONG1103,&#xD;
        currently ongoing, comparing the efficacy of the first generational EGFR-TKI erlotinib and&#xD;
        gemcitabine combined with cisplatin as neoadjuvant therapy for stage IIIA-N2 EGFR&#xD;
        mutation-positive non-small-cell lung cancer, did not yield significantly positive objective&#xD;
        remission rate (ORR) results.&#xD;
  &#xD;
        Furmonertinib is a third-generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase&#xD;
        inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations.Furmonertinib&#xD;
        demonstrates definite efficacy and favorable safety in first-line EGFR-sensitive mutations&#xD;
        and EGFR T790M Mutations in second-line and late-line treatment of advanced NSCLC.The aim of&#xD;
        this study was to explore the efficacy and safety of furmonertinib neoadjuvant therapy for&#xD;
        resectable stage II-IIIB EGFR-sensitive mutant non-small cell lung cancer efficacy and&#xD;
        safety. Patinents are planned to be recruited from five centers in China. Eligible patients&#xD;
        will receive furmonertinib neoadjuvant therapy for 8 weeks to evaluate the efficacy and&#xD;
        safety of furmonnertinib neoadjuvant.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Not Provided&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Approximately 8 weeks following the first dose of study drug</time_frame>
      <description>According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy with furmonertinib CT scans scans assessed the proportion of patients in partial and complete remission.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Main Pathological Response（MPR）</measure>
      <time_frame>Approximately 12 weeks following the first dose of study drug</time_frame>
      <description>Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pathological Complete Response Rate（pCR)</measure>
      <time_frame>Approximately 12 weeks following the first dose of study drug</time_frame>
      <description>The proportion of patients with pathological response rate in the resected tumor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pathological Nodal Downstaging Rate</measure>
      <time_frame>Approximately 12 weeks following the first dose of study drug</time_frame>
      <description>Neoadjuvant confirmed by pathologic evaluation of tumors and other tissues removed during surgery Percentage of patients downregulated from lymph node-positive to negative after treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delayed Surgery Rate</measure>
      <time_frame>Approximately 12 weeks following the first dose of study drug</time_frame>
      <description>Proportion of surgeries performed 2 weeks after the last dose of furmonertinib because of adverse drug reactions and other reasons.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of R0 Resection</measure>
      <time_frame>Approximately 12 weeks following the first dose of study drug</time_frame>
      <description>The proportion of patients with R0 resection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of minimally invasive mid-rotation open chest</measure>
      <time_frame>Approximately 12 weeks following the first dose of study drug</time_frame>
      <description>Proportion of minimally invasive surgeries converted to open thoracic for various reasons</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse drug events (AE)</measure>
      <time_frame>Approximately 12 weeks following the first dose of study drug</time_frame>
      <description>Unfavorable clinical events in the course of drug treatment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Non-Small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Furmonertinib (AST2818) 80mg QD group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients enrolled into this study will receive furmonertinib 80mg for 8 weeks neoadjuvant therapy before surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Furmonertinib</intervention_name>
      <description>Furmonertinib 80mg QD oral 8 weeks.</description>
      <arm_group_label>Furmonertinib (AST2818) 80mg QD group</arm_group_label>
      <other_name>Furmonertinib(AST2818)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1）Provide informed consent prior to any study specific procedures&#xD;
  &#xD;
            -  2）at least 18 years of age，not more than 75 years&#xD;
  &#xD;
            -  3）Histology or cytology diagnose of non-small cell lung cancer within 60 days&#xD;
  &#xD;
            -  4）ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the&#xD;
               previous 2 weeks&#xD;
  &#xD;
            -  5）Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the&#xD;
               investigator (8 thUICCTNM staging), with stage IIIB only including cT3N2M0 patients&#xD;
  &#xD;
            -  6）According to RECIST 1.1, patients have at least one measureable tumor lesion (The&#xD;
               longest axis ≥10mm)&#xD;
  &#xD;
            -  7）EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other&#xD;
               EGFR mutations)&#xD;
  &#xD;
            -  8）Without prior anti-tumor treatment&#xD;
  &#xD;
            -  9) Withe adequate organ function of hematology, liver and kidney&#xD;
  &#xD;
            -  10）Using adequate and effective contraception, Male patients should be use condoms;&#xD;
               women should refrain from breastfeeding and have a negative pregnancy test prior to&#xD;
               the first administration of the study drug if within during child-bearing age&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1）Dual or multiple primary NSCLC&#xD;
  &#xD;
            -  2）Any prior anti-tumor treatment&#xD;
  &#xD;
            -  3）With history of other malignancy except for radical resected tumors without&#xD;
               recurrence for 5 years or more&#xD;
  &#xD;
            -  4）History of interstitial lung disease or with relative risk factors&#xD;
  &#xD;
            -  5）Diseases or clinical states with severe abnormalities of gastrointestinal function&#xD;
               that may interfere with the ingestion, transit, or absorption of the study drug.e.g.,&#xD;
               inability to take medication orally, uncontrolled nausea and vomiting&#xD;
  &#xD;
            -  6）Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21&#xD;
               days before enrolment; use of traditional Chinese medicine with anti-tumor effect&#xD;
               within 21 days before enrolment&#xD;
  &#xD;
            -  7）With severe or uncontrolled systemic disease such as uncontrolled hypertention,&#xD;
               diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction&#xD;
               within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring&#xD;
               infusion treatment&#xD;
  &#xD;
            -  8）Prolongation of ECG QTc or with relative risk factors&#xD;
  &#xD;
            -  9）psychopath and/or mental illness&#xD;
  &#xD;
            -  10）Pre-existing or coexisting bleeding disorders&#xD;
  &#xD;
            -  11）Women with pregnancy or breastfeeding&#xD;
  &#xD;
            -  12）Allergic to study drugs or any component&#xD;
  &#xD;
            -  13）Other conditions that, in the opinion of the investigator, make participation in&#xD;
               this trial inappropriate&#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_contact>
      <last_name>di ge</last_name>
      <phone>86-18202188606</phone>
      <email>gedi@zs-hospital.sh.cn</email>
    </overall_contact>
    <link>
      <url>https://seer.cancer.gov/</url>
      <description>Related Info</description>
    </link>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>furmonertinib</keyword>
    <keyword>neoadjuvant therapy</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>Aflutinib</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05987826
  org study id: B2023-170R
  nct id: NCT05987826
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  EGFR-TKI has firmly established itself as a first-line treatment for advanced lung cancer
        with EGFR-sensitive mutations, and the ADAURA study has added to its indications for use as
        postoperative adjuvant therapy in early- and mid-stage lung cancer.However, clinical data on
        neoadjuvant EGFR-TKI therapy are still incomplete. A phase II clinical study, CTONG1103,
        currently ongoing, comparing the efficacy of the first generational EGFR-TKI erlotinib and
        gemcitabine combined with cisplatin as neoadjuvant therapy for stage IIIA-N2 EGFR
        mutation-positive non-small-cell lung cancer, did not yield significantly positive objective
        remission rate (ORR) results.
  
        Furmonertinib is a third-generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase
        inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations.Furmonertinib
        demonstrates definite efficacy and favorable safety in first-line EGFR-sensitive mutations
        and EGFR T790M Mutations in second-line and late-line treatment of advanced NSCLC.The aim of
        this study was to explore the efficacy and safety of furmonertinib neoadjuvant therapy for
        resectable stage II-IIIB EGFR-sensitive mutant non-small cell lung cancer efficacy and
        safety. Patinents are planned to be recruited from five centers in China. Eligible patients
        will receive furmonertinib neoadjuvant therapy for 8 weeks to evaluate the efficacy and
        safety of furmonnertinib neoadjuvant.
  Not Provided
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: objective response rate(ORR)
  time frame: Approximately 8 weeks following the first dose of study drug
  description: According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy with furmonertinib CT scans scans assessed the proportion of patients in partial and complete remission.
  measure: Main Pathological Response（MPR）
  time frame: Approximately 12 weeks following the first dose of study drug
  description: Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
  measure: Pathological Complete Response Rate（pCR)
  time frame: Approximately 12 weeks following the first dose of study drug
  description: The proportion of patients with pathological response rate in the resected tumor.
  measure: Pathological Nodal Downstaging Rate
  time frame: Approximately 12 weeks following the first dose of study drug
  description: Neoadjuvant confirmed by pathologic evaluation of tumors and other tissues removed during surgery Percentage of patients downregulated from lymph node-positive to negative after treatment
  measure: Delayed Surgery Rate
  time frame: Approximately 12 weeks following the first dose of study drug
  description: Proportion of surgeries performed 2 weeks after the last dose of furmonertinib because of adverse drug reactions and other reasons.
  measure: Rate of R0 Resection
  time frame: Approximately 12 weeks following the first dose of study drug
  description: The proportion of patients with R0 resection.
  measure: Percentage of minimally invasive mid-rotation open chest
  time frame: Approximately 12 weeks following the first dose of study drug
  description: Proportion of minimally invasive surgeries converted to open thoracic for various reasons
  measure: Incidence of adverse drug events (AE)
  time frame: Approximately 12 weeks following the first dose of study drug
  description: Unfavorable clinical events in the course of drug treatment
  arm group label: Furmonertinib (AST2818) 80mg QD group
  arm group type: Experimental
  description: All patients enrolled into this study will receive furmonertinib 80mg for 8 weeks neoadjuvant therapy before surgery.
  intervention type: Drug
  intervention name: Furmonertinib
  description: Furmonertinib 80mg QD oral 8 weeks.
  arm group label: Furmonertinib (AST2818) 80mg QD group
  other name: Furmonertinib(AST2818)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: di ge
  phone: 86-18202188606
  email: gedi@zs-hospital.sh.cn
  url: https://seer.cancer.gov/
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  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Aflutinib