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Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tirelizumab;Chemotherapy monotherapy
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pathologically confirmed recurrent/metastatic non-small cell lung cancer with local recurrence or distant metastasis after prior radiotherapy and/or surgery, or with distant metastasis at the time of admission. The age range is between 18 and 85. Predicted survival ≥12 weeks. Exclusion Criteria: Patients with other malignant tumors. Positive tests for EGFR mutation and ALK fusion gene have been confirmed. Partial comorbidity. other.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tirelizumab in combination with chemotherapy monotherapy

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Objective response rate
    Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients

    Secondary Outcome Measures

    Disease control rate
    Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.
    Progression-free survival time
    The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
    Overall survival time
    The time between the patient's date of first treatment and death from any cause.

    Full Information

    First Posted
    April 23, 2023
    Last Updated
    July 27, 2023
    Sponsor
    Second Affiliated Hospital of Guangzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05965102
    Brief Title
    Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2025 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital of Guangzhou Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    31 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tirelizumab in combination with chemotherapy monotherapy
    Arm Type
    Experimental
    Arm 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(s)
    Tirelizumab;Chemotherapy monotherapy
    Intervention Description
    Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2
    Primary Outcome Measure Information:
    Title
    Objective response rate
    Description
    Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients
    Time Frame
    Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
    Secondary Outcome Measure Information:
    Title
    Disease control rate
    Description
    Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.
    Time Frame
    Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
    Title
    Progression-free survival time
    Description
    The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
    Time Frame
    Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
    Title
    Overall survival time
    Description
    The time between the patient's date of first treatment and death from any cause.
    Time Frame
    Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pathologically confirmed recurrent/metastatic non-small cell lung cancer with local recurrence or distant metastasis after prior radiotherapy and/or surgery, or with distant metastasis at the time of admission. The age range is between 18 and 85. Predicted survival ≥12 weeks. Exclusion Criteria: Patients with other malignant tumors. Positive tests for EGFR mutation and ALK fusion gene have been confirmed. Partial comorbidity. other.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jingqi Chen, MD
    Phone
    18928787238
    Email
    chenjingqi2002@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12661267
    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.
    Results Reference
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    PubMed Identifier
    21079145
    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.
    Results Reference
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    PubMed Identifier
    11784875
    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.
    Results Reference
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    PubMed Identifier
    33872070
    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.
    Results Reference
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    PubMed Identifier
    33347829
    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.
    Results Reference
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    PubMed Identifier
    32199466
    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.
    Results Reference
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    Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer

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