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/NCT05965102</url>
    </required_header>
    <id_info>
      <org_study_id>2022-LCYJ-ZF-10</org_study_id>
      <nct_id>NCT05965102</nct_id>
    </id_info>
    <brief_title>Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer</brief_title>
    <official_title>A Prospective, Single-arm, Single-center, Exploratory Clinical Study of Tirelizumab Combined With Chemotherapy in First-line Treatment of ECOG PS 2 Points in Relapsed/Metastatic Non-small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital of Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital of Guangzhou Medical University</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 is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the&#xD;
        efficacy and safety of the PD-1 antibody tirelizumab combined with chemotherapy monotherapy&#xD;
        in patients with relapsed/metastatic non-small cell lung cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the&#xD;
        efficacy and safety of the PD-1 antibody tirellizumab combined with chemotherapy monotherapy&#xD;
        in patients with relapsed/metastatic non-small cell lung cancer. This study prospectively&#xD;
        collected disease history, treatment history, demographic data, baseline data during&#xD;
        treatment, each treatment visit data, efficacy data, and safety data of NSCLC patients with&#xD;
        EGFR and ALK driver negative ECOG PS 2 scores treated with tirellizumab combined with&#xD;
        monotherapy. The subjects did not voluntarily withdraw from the test or the researchers&#xD;
        believed that the subjects were not suitable for further test. Each subject will be treated&#xD;
        until the disease progresses or the toxic and side effects caused by the drugs are&#xD;
        intolerable, and the follow-up treatment plan, treatment status and survival data of the&#xD;
        patients still need to be collected.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
    <phase>Phase 1</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</measure>
      <time_frame>Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.</time_frame>
      <description>Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease control rate</measure>
      <time_frame>Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.</time_frame>
      <description>Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival time</measure>
      <time_frame>Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.</time_frame>
      <description>The time between the patient's first treatment date and any recorded tumor progression or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival time</measure>
      <time_frame>Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.</time_frame>
      <description>The time between the patient's date of first treatment and death from any cause.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">31</enrollment>
    <condition>Non-small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Tirelizumab in combination with chemotherapy monotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This study is a one-arm, exploratory study and does not involve randomization. There was only one trial group of tirellizumab plus chemotherapy monotherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tirelizumab；Chemotherapy monotherapy</intervention_name>
      <description>Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2</description>
      <arm_group_label>Tirelizumab in combination with chemotherapy monotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Pathologically confirmed recurrent/metastatic non-small cell lung cancer with local&#xD;
               recurrence or distant metastasis after prior radiotherapy and/or surgery, or with&#xD;
               distant metastasis at the time of admission.&#xD;
  &#xD;
            2. The age range is between 18 and 85.&#xD;
  &#xD;
            3. Predicted survival ≥12 weeks.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with other malignant tumors.&#xD;
  &#xD;
            2. Positive tests for EGFR mutation and ALK fusion gene have been confirmed.&#xD;
  &#xD;
            3. Partial comorbidity.&#xD;
  &#xD;
            4. other.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jingqi Chen, MD</last_name>
      <phone>18928787238</phone>
      <email>chenjingqi2002@163.com</email>
    </overall_contact>
    <reference>
      <citation>Novello S, Le Chevalier T. Chemotherapy for non-small-cell lung cancer. Part 1: Early-stage disease. Oncology (Williston Park). 2003 Mar;17(3):357-64.</citation>
      <PMID>12661267</PMID>
    </reference>
    <reference>
      <citation>Langer CJ, Besse B, Gualberto A, Brambilla E, Soria JC. The evolving role of histology in the management of advanced non-small-cell lung cancer. J Clin Oncol. 2010 Dec 20;28(36):5311-20. doi: 10.1200/JCO.2010.28.8126. Epub 2010 Nov 15.</citation>
      <PMID>21079145</PMID>
    </reference>
    <reference>
      <citation>Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.</citation>
      <PMID>11784875</PMID>
    </reference>
    <reference>
      <citation>Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leal TA, Riess JW, Jensen E, Zhao B, Pietanza MC, Brahmer JR. Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score &gt;/= 50. J Clin Oncol. 2021 Jul 20;39(21):2339-2349. doi: 10.1200/JCO.21.00174. Epub 2021 Apr 19.</citation>
      <PMID>33872070</PMID>
    </reference>
    <reference>
      <citation>Zhou C, Chen G, Huang Y, Zhou J, Lin L, Feng J, Wang Z, Shu Y, Shi J, Hu Y, Wang Q, Cheng Y, Wu F, Chen J, Lin X, Wang Y, Huang J, Cui J, Cao L, Liu Y, Zhang Y, Pan Y, Zhao J, Wang L, Chang J, Chen Q, Ren X, Zhang W, Fan Y, He Z, Fang J, Gu K, Dong X, Zhang T, Shi W, Zou J; CameL Study Group. Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial. Lancet Respir Med. 2021 Mar;9(3):305-314. doi: 10.1016/S2213-2600(20)30365-9. Epub 2020 Dec 18.</citation>
      <PMID>33347829</PMID>
    </reference>
    <reference>
      <citation>Middleton G, Brock K, Savage J, Mant R, Summers Y, Connibear J, Shah R, Ottensmeier C, Shaw P, Lee SM, Popat S, Barrie C, Barone G, Billingham L. Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2): a single arm, phase 2 trial. Lancet Respir Med. 2020 Sep;8(9):895-904. doi: 10.1016/S2213-2600(20)30033-3. Epub 2020 Mar 19.</citation>
      <PMID>32199466</PMID>
    </reference>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 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>
      <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>
  
  
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/NCT05965102
  org study id: 2022-LCYJ-ZF-10
  nct id: NCT05965102
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the
        efficacy and safety of the PD-1 antibody tirelizumab combined with chemotherapy monotherapy
        in patients with relapsed/metastatic non-small cell lung cancer.
  This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the
        efficacy and safety of the PD-1 antibody tirellizumab combined with chemotherapy monotherapy
        in patients with relapsed/metastatic non-small cell lung cancer. This study prospectively
        collected disease history, treatment history, demographic data, baseline data during
        treatment, each treatment visit data, efficacy data, and safety data of NSCLC patients with
        EGFR and ALK driver negative ECOG PS 2 scores treated with tirellizumab combined with
        monotherapy. The subjects did not voluntarily withdraw from the test or the researchers
        believed that the subjects were not suitable for further test. Each subject will be treated
        until the disease progresses or the toxic and side effects caused by the drugs are
        intolerable, and the follow-up treatment plan, treatment status and survival data of the
        patients still need to be collected.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate
  time frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
  description: Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients
  measure: Disease control rate
  time frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
  description: Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.
  measure: Progression-free survival time
  time frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
  description: The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
  measure: Overall survival time
  time frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
  description: The time between the patient's date of first treatment and death from any cause.
  arm group label: Tirelizumab in combination with chemotherapy monotherapy
  arm group type: Experimental
  description: This study is a one-arm, exploratory study and does not involve randomization. There was only one trial group of tirellizumab plus chemotherapy monotherapy.
  intervention type: Drug
  intervention name: Tirelizumab；Chemotherapy monotherapy
  description: Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2
  arm group label: Tirelizumab in combination with chemotherapy monotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Jingqi Chen, MD
  phone: 18928787238
  email: chenjingqi2002@163.com
  citation: Novello S, Le Chevalier T. Chemotherapy for non-small-cell lung cancer. Part 1: Early-stage disease. Oncology (Williston Park). 2003 Mar;17(3):357-64.
  PMID: 12661267
  citation: Langer CJ, Besse B, Gualberto A, Brambilla E, Soria JC. The evolving role of histology in the management of advanced non-small-cell lung cancer. J Clin Oncol. 2010 Dec 20;28(36):5311-20. doi: 10.1200/JCO.2010.28.8126. Epub 2010 Nov 15.
  PMID: 21079145
  citation: Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
  PMID: 11784875
  citation: Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leal TA, Riess JW, Jensen E, Zhao B, Pietanza MC, Brahmer JR. Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score >/= 50. J Clin Oncol. 2021 Jul 20;39(21):2339-2349. doi: 10.1200/JCO.21.00174. Epub 2021 Apr 19.
  PMID: 33872070
  citation: Zhou C, Chen G, Huang Y, Zhou J, Lin L, Feng J, Wang Z, Shu Y, Shi J, Hu Y, Wang Q, Cheng Y, Wu F, Chen J, Lin X, Wang Y, Huang J, Cui J, Cao L, Liu Y, Zhang Y, Pan Y, Zhao J, Wang L, Chang J, Chen Q, Ren X, Zhang W, Fan Y, He Z, Fang J, Gu K, Dong X, Zhang T, Shi W, Zou J; CameL Study Group. Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial. Lancet Respir Med. 2021 Mar;9(3):305-314. doi: 10.1016/S2213-2600(20)30365-9. Epub 2020 Dec 18.
  PMID: 33347829
  citation: Middleton G, Brock K, Savage J, Mant R, Summers Y, Connibear J, Shah R, Ottensmeier C, Shaw P, Lee SM, Popat S, Barrie C, Barone G, Billingham L. Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2): a single arm, phase 2 trial. Lancet Respir Med. 2020 Sep;8(9):895-904. doi: 10.1016/S2213-2600(20)30033-3. Epub 2020 Mar 19.
  PMID: 32199466
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  sharing ipd: No