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Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors)

Primary Purpose

Non Small Cell Lung Cancer Recurrent

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Toripalimab, Anlotinib and Chemotherapy
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer Recurrent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up; Diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma (NSCLC) by cytology or histology; First-line PD-1/PD-L1 inhibitors treatment failure; Provide detectable specimens (tissue or blood) for genotyping before enrollment, and the patients should be with negative EGFR and ALK gene test results; Had at least one measurable lesion according to RECIST 1.1 criteria Anticipated overall survival more than 3 months; ECOG (Eastern Cooperative Oncology Group) scale 0-2; Normal organ function and bone marrow function; Resistant to first-line immune checkpoint inhibitor therapy and discontinued for more than 4 weeks; Women of childbearing age must have taken reliable contraceptive measures and performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the results were negative, and were willing to use appropriate methods during the trial and 4 weeks after the last administration of the test drug. Exclusion Criteria: Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer) ; Patients who have previously permanently discontinued immunotherapy due to immune-related serious adverse reactions; Patients who previously treated with antiangiogenic agents; A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery; Active, known or suspected autoimmune disease; Active or chronic hepatitis C or/and hepatitis B infection; History of interstitial lung disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Toripalimab, Chemotherapy and Antiangiogenic Agents

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progress free survival
    Progress free survival is defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause.

    Secondary Outcome Measures

    Objective Response Rate
    Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
    Overall Survival
    Overall survival is defined as the time until death due to any cause.
    Disease Control Rate
    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

    Full Information

    First Posted
    April 24, 2023
    Last Updated
    April 24, 2023
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05842018
    Brief Title
    Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors)
    Official Title
    Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors): a Prospective, Single-arm, Phase II Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Toripalimab combined with Chemotherapy and Antiangiogenic Agents in patients with Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 inhibitors)

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Toripalimab, Chemotherapy and Antiangiogenic Agents
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Toripalimab, Anlotinib and Chemotherapy
    Other Intervention Name(s)
    JS001
    Intervention Description
    Combination therapy: Toripalimab 240mg will be intravenously administered on Day 1, Q3W; anlotinib: 12 mg qd d1-d14, d15-d21 discontinued, Q3W; investigator selected chemotherapy regimen (paclitaxel, pemetrexed or gemcitabine and other chemotherapeutic drugs which were not administered in the first-line therapy) for a total of 4 cycles. Maintenance therapy: After combination therapy, Patients who achieved complete response(CR), partial response (PR), or stable disease (SD) were administered with toripalimab plus anlotinib as maintenance therapy. until disease progression or intolerable toxicity, treatment for 2 years, investigator decision, withdrawal of consent, or death.
    Primary Outcome Measure Information:
    Title
    Progress free survival
    Description
    Progress free survival is defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause.
    Time Frame
    until Progressive Disease (PD) or death (up to 24 months)
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate
    Description
    Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
    Time Frame
    each 21 days up to intolerance the toxicity or PD (up to 24 months)
    Title
    Overall Survival
    Description
    Overall survival is defined as the time until death due to any cause.
    Time Frame
    from first dose of study treatment until death (up to 24 months)
    Title
    Disease Control Rate
    Description
    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
    Time Frame
    each 21 days up to intolerance the toxicity or PD (up to 24 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up; Diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma (NSCLC) by cytology or histology; First-line PD-1/PD-L1 inhibitors treatment failure; Provide detectable specimens (tissue or blood) for genotyping before enrollment, and the patients should be with negative EGFR and ALK gene test results; Had at least one measurable lesion according to RECIST 1.1 criteria Anticipated overall survival more than 3 months; ECOG (Eastern Cooperative Oncology Group) scale 0-2; Normal organ function and bone marrow function; Resistant to first-line immune checkpoint inhibitor therapy and discontinued for more than 4 weeks; Women of childbearing age must have taken reliable contraceptive measures and performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the results were negative, and were willing to use appropriate methods during the trial and 4 weeks after the last administration of the test drug. Exclusion Criteria: Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer) ; Patients who have previously permanently discontinued immunotherapy due to immune-related serious adverse reactions; Patients who previously treated with antiangiogenic agents; A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery; Active, known or suspected autoimmune disease; Active or chronic hepatitis C or/and hepatitis B infection; History of interstitial lung disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dongying Liu
    Phone
    +86 022 23340123
    Ext
    1157
    Email
    ldytjnk@sina.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors)

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