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/NCT05965557</url>
    </required_header>
    <id_info>
      <org_study_id>PROMISEPLUS-101</org_study_id>
      <nct_id>NCT05965557</nct_id>
    </id_info>
    <brief_title>Exploration of Predictive Markers of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer</brief_title>
    <official_title>A Biomarker Study for Predicting the Response of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer Based on Circulating Tumor DNA and Homologous Recombination Deficiency Analysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Geneplus-Beijing Co. Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Geneplus-Beijing 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>
        Neoadjuvant immunotherapy has become the standard perioperative treatment in lung cancer, but&#xD;
        its effective predictive biomarkers are lacking. A small cohort reported that homologous&#xD;
        recombination deficiency (HRD) can be used as a reliable biomarker to predict the efficacy of&#xD;
        neoadjuvant immunotherapy, but the findings need to be validated in larger cohorts. Moreover,&#xD;
        circulating tumor DNA (ctDNA) has the potential to predict the therapeutic efficacy of&#xD;
        neoadjuvant immunotherapy.&#xD;
  &#xD;
        This study intends to prospectively collect patients with driver-negative stage II-IIIB NSCLC&#xD;
        who are scheduled to receive neoadjuvant immunotherapy and surgical resection and verify the&#xD;
        value of HRD in predicting the efficacy of neoadjuvant immunotherapy. Meanwhile, the blood&#xD;
        samples before and after neoadjuvant immunotherapy were collected for high-depth ctDNA&#xD;
        detection to explore the correlation between the dynamic changes of ctDNA and the efficacy&#xD;
        and prognosis of neoadjuvant immunotherapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 19, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation between HRD and MPR rate/2 years DFS</measure>
      <time_frame>2023/12-2025/12</time_frame>
      <description>Correlation between homologous recombination deficiency (HRD) events and major pathological response (MPR) rate and DFS of 2 years</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Lung Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Stage II-IIIB NSCLC who are undergoing neoadjuvant immunotherapy and surgical resection&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stage II-IIIB NSCLC&#xD;
  &#xD;
            -  EGFR/ALK negative&#xD;
  &#xD;
            -  The subjects voluntarily joined the study, signed informed consent, had good&#xD;
               compliance, and cooperated with follow-up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A history of other malignancies within the past 5 years&#xD;
  &#xD;
            -  Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shun Lu, PhD</last_name>
      <phone>+86 18017321551</phone>
      <email>shunlu@sjtu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Chest Hospital</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shun Lu</last_name>
        <phone>+86 18017321551</phone>
        <email>shunlu@sjtu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Zhou Z, Ding Z, Yuan J, Shen S, Jian H, Tan Q, Yang Y, Chen Z, Luo Q, Cheng X, Yu Y, Niu X, Qian L, Chen X, Gu L, Liu R, Ma S, Huang J, Chen T, Li Z, Ji W, Song L, Shen L, Jiang L, Yu Z, Zhang C, Tai Z, Wang C, Chen R, Carbone DP, Xia X, Lu S. Homologous recombination deficiency (HRD) can predict the therapeutic outcomes of immuno-neoadjuvant therapy in NSCLC patients. J Hematol Oncol. 2022 May 18;15(1):62. doi: 10.1186/s13045-022-01283-7.</citation>
      <PMID>35585646</PMID>
    </reference>
    <reference>
      <citation>Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.</citation>
      <PMID>32979984</PMID>
    </reference>
    <reference>
      <citation>Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.</citation>
      <PMID>35403841</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</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>
    </condition_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/NCT05965557
  org study id: PROMISEPLUS-101
  nct id: NCT05965557
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Neoadjuvant immunotherapy has become the standard perioperative treatment in lung cancer, but
        its effective predictive biomarkers are lacking. A small cohort reported that homologous
        recombination deficiency (HRD) can be used as a reliable biomarker to predict the efficacy of
        neoadjuvant immunotherapy, but the findings need to be validated in larger cohorts. Moreover,
        circulating tumor DNA (ctDNA) has the potential to predict the therapeutic efficacy of
        neoadjuvant immunotherapy.
  
        This study intends to prospectively collect patients with driver-negative stage II-IIIB NSCLC
        who are scheduled to receive neoadjuvant immunotherapy and surgical resection and verify the
        value of HRD in predicting the efficacy of neoadjuvant immunotherapy. Meanwhile, the blood
        samples before and after neoadjuvant immunotherapy were collected for high-depth ctDNA
        detection to explore the correlation between the dynamic changes of ctDNA and the efficacy
        and prognosis of neoadjuvant immunotherapy.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation between HRD and MPR rate/2 years DFS
  time frame: 2023/12-2025/12
  description: Correlation between homologous recombination deficiency (HRD) events and major pathological response (MPR) rate and DFS of 2 years
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Shun Lu, PhD
  phone: +86 18017321551
  email: shunlu@sjtu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Zhou Z, Ding Z, Yuan J, Shen S, Jian H, Tan Q, Yang Y, Chen Z, Luo Q, Cheng X, Yu Y, Niu X, Qian L, Chen X, Gu L, Liu R, Ma S, Huang J, Chen T, Li Z, Ji W, Song L, Shen L, Jiang L, Yu Z, Zhang C, Tai Z, Wang C, Chen R, Carbone DP, Xia X, Lu S. Homologous recombination deficiency (HRD) can predict the therapeutic outcomes of immuno-neoadjuvant therapy in NSCLC patients. J Hematol Oncol. 2022 May 18;15(1):62. doi: 10.1186/s13045-022-01283-7.
  PMID: 35585646
  citation: Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.
  PMID: 32979984
  citation: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
  PMID: 35403841
  responsible party type: Sponsor
  mesh term: Lung Neoplasms