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The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC

Primary Purpose

Lung Neoplasms

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)
Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Envafolimab/SCLC/Chemoradiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The result of histopathological or cytological diagnosis is small cell lung cancer. Diagnosed as limited stage by imaging examination (lesion limited to half chest and one radiotherapy field, without malignant pleural or pericardial effusion); And at least one measurable lesion that meets the RECIST 1.1 standard. Have not received systematic treatment in the past, and initially underwent 2 cycles of etoposide+cisplatin/carboplatin induction therapy. Age 18-75 years old, male or non pregnant female. The expected survival period is>3 months. ECOG score 0-1. Weight>30 kilograms. All patients underwent chest CT, head MRI, abdominal CT or MRI, and whole body bone scan before treatment to clarify. Hematological indicators: white blood cell (WBC) count ≥ 4 * 109/L, absolute neutrophil count (ANC) ≥ 1.5 * 109/L, hemoglobin (Hb) level>100 g/L, platelet (Plt) count>100 * 109/L, serum creatinine (Cr) level<1.5 times the upper limit of normal value, serum alanine transaminase (AST) and glutamic transaminase (ALT) levels<2.5 times the upper limit of normal value, and serum bilirubin level ≤ 1.5 times the upper limit of normal value. The patient has signed an informed notice and is willing and able to comply with the visit, treatment plan, laboratory examination, and other research procedures of the research plan. Exclusion Criteria: Patients with non-small cell lung cancer or mixed components of small cell lung cancer in histopathology. Patients with extensive stage small cell lung cancer (ES-SCLC). Merge malignant pleural effusion and pericardial effusion. Pregnant and lactating women. Merge patients with more severe underlying diseases. Patients who have previously been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.). Patients may require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive doses for comorbidities. Patients with immunodeficiency disorders and a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; vitiligo or childhood asthma. Patients who have completely relieved and do not require any intervention after adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included). Those whose laboratory test values during the screening period before enrollment do not meet relevant standards. Patients with significantly reduced heart, liver, lung, kidney, and bone marrow function. Serious and uncontrolled internal diseases and infections. Simultaneously using other investigational drugs or in other clinical trials. Refusal or inability to sign informed consent form for participation in the experiment. A history of allergies to etoposide, cisplatin, or any excipients. Researchers have determined that patients are not suitable to participate in the study and are unlikely to comply with the study procedures, limitations, and requirements.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Hypofractionated radiotherapy group

    Conventional Radiotherapy

    Arm Description

    Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.

    Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.

    Outcomes

    Primary Outcome Measures

    2-year PFS rate
    2-yaer progression-free survival rate

    Secondary Outcome Measures

    ORR
    Objective Response Rate
    DCR
    Disease control rate
    DOR
    Duration of response
    OS
    Overall survival
    Adverse event rate Adverse event rate Adverse event rate
    Number of participants with adverse events as a measure of safety and tolerability

    Full Information

    First Posted
    April 30, 2023
    Last Updated
    June 12, 2023
    Sponsor
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05904015
    Brief Title
    The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC
    Official Title
    A Prospective, Two Cohort, Multicenter Phase II Clinical Study of Envafolimab Combined With Concurrent Chemoradiotherapy and Immune Maintenance Therapy For Limited Stage Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2026 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    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
    To evaluate the efficacy and safety of envafolimab combined with concurrent chemoradiotherapy in limited stage small cell lung cancer.
    Detailed Description
    Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody. Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Neoplasms
    Keywords
    Envafolimab/SCLC/Chemoradiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypofractionated radiotherapy group
    Arm Type
    Experimental
    Arm Description
    Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
    Arm Title
    Conventional Radiotherapy
    Arm Type
    Experimental
    Arm Description
    Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
    Intervention Type
    Drug
    Intervention Name(s)
    Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)
    Other Intervention Name(s)
    Hypofractionated Radiotherapy Group
    Intervention Description
    Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
    Intervention Type
    Drug
    Intervention Name(s)
    Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)
    Other Intervention Name(s)
    Conventional Radiotherapy Group
    Intervention Description
    Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
    Primary Outcome Measure Information:
    Title
    2-year PFS rate
    Description
    2-yaer progression-free survival rate
    Time Frame
    From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
    Secondary Outcome Measure Information:
    Title
    ORR
    Description
    Objective Response Rate
    Time Frame
    From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
    Title
    DCR
    Description
    Disease control rate
    Time Frame
    From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
    Title
    DOR
    Description
    Duration of response
    Time Frame
    From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
    Title
    OS
    Description
    Overall survival
    Time Frame
    From date of randomization until the date of death(up to 24 months)
    Title
    Adverse event rate Adverse event rate Adverse event rate
    Description
    Number of participants with adverse events as a measure of safety and tolerability
    Time Frame
    From date of randomization until the date of toxicity or PD (up to 24 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The result of histopathological or cytological diagnosis is small cell lung cancer. Diagnosed as limited stage by imaging examination (lesion limited to half chest and one radiotherapy field, without malignant pleural or pericardial effusion); And at least one measurable lesion that meets the RECIST 1.1 standard. Have not received systematic treatment in the past, and initially underwent 2 cycles of etoposide+cisplatin/carboplatin induction therapy. Age 18-75 years old, male or non pregnant female. The expected survival period is>3 months. ECOG score 0-1. Weight>30 kilograms. All patients underwent chest CT, head MRI, abdominal CT or MRI, and whole body bone scan before treatment to clarify. Hematological indicators: white blood cell (WBC) count ≥ 4 * 109/L, absolute neutrophil count (ANC) ≥ 1.5 * 109/L, hemoglobin (Hb) level>100 g/L, platelet (Plt) count>100 * 109/L, serum creatinine (Cr) level<1.5 times the upper limit of normal value, serum alanine transaminase (AST) and glutamic transaminase (ALT) levels<2.5 times the upper limit of normal value, and serum bilirubin level ≤ 1.5 times the upper limit of normal value. The patient has signed an informed notice and is willing and able to comply with the visit, treatment plan, laboratory examination, and other research procedures of the research plan. Exclusion Criteria: Patients with non-small cell lung cancer or mixed components of small cell lung cancer in histopathology. Patients with extensive stage small cell lung cancer (ES-SCLC). Merge malignant pleural effusion and pericardial effusion. Pregnant and lactating women. Merge patients with more severe underlying diseases. Patients who have previously been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.). Patients may require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive doses for comorbidities. Patients with immunodeficiency disorders and a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; vitiligo or childhood asthma. Patients who have completely relieved and do not require any intervention after adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included). Those whose laboratory test values during the screening period before enrollment do not meet relevant standards. Patients with significantly reduced heart, liver, lung, kidney, and bone marrow function. Serious and uncontrolled internal diseases and infections. Simultaneously using other investigational drugs or in other clinical trials. Refusal or inability to sign informed consent form for participation in the experiment. A history of allergies to etoposide, cisplatin, or any excipients. Researchers have determined that patients are not suitable to participate in the study and are unlikely to comply with the study procedures, limitations, and requirements.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    LvHua Wang, Doc
    Phone
    0755-66618168
    Email
    wlhwq@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Jiang, Doc
    Phone
    0755-66618168
    Email
    szchiec@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    LvHua Wang, Doc
    Organizational Affiliation
    Cancer Hospital Chinese Academy of Medical Sciences,ShenZhen Cencer
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30207593
    Citation
    Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
    Results Reference
    background
    PubMed Identifier
    17008692
    Citation
    Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
    Results Reference
    background
    PubMed Identifier
    17270313
    Citation
    Toh CK, Gao F, Lim WT, Leong SS, Fong KW, Yap SP, Hsu AA, Eng P, Koong HN, Thirugnanam A, Tan EH. Differences between small-cell lung cancer and non-small-cell lung cancer among tobacco smokers. Lung Cancer. 2007 May;56(2):161-6. doi: 10.1016/j.lungcan.2006.12.016. Epub 2007 Jan 31.
    Results Reference
    background
    PubMed Identifier
    25355724
    Citation
    Sun JM, Choi YL, Ji JH, Ahn JS, Kim KM, Han J, Ahn MJ, Park K. Small-cell lung cancer detection in never-smokers: clinical characteristics and multigene mutation profiling using targeted next-generation sequencing. Ann Oncol. 2015 Jan;26(1):161-166. doi: 10.1093/annonc/mdu504. Epub 2014 Oct 29.
    Results Reference
    background
    PubMed Identifier
    12488411
    Citation
    Sundstrom S, Bremnes RM, Kaasa S, Aasebo U, Hatlevoll R, Dahle R, Boye N, Wang M, Vigander T, Vilsvik J, Skovlund E, Hannisdal E, Aamdal S; Norwegian Lung Cancer Study Group. Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: results from a randomized phase III trial with 5 years' follow-up. J Clin Oncol. 2002 Dec 15;20(24):4665-72. doi: 10.1200/JCO.2002.12.111.
    Results Reference
    background

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    The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC

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