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a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1210
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • 18 to 75 years old
  • Confirmed diagnosis of Extensive small cell lung cancer
  • Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
  • The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
  • have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
  • The estimated survival period is more than 8 weeks
  • The subjects voluntarily joined the study, signed informed consent,

Exclusion Criteria:

  • Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI);
  • Leptomeningeal diseases
  • Uncontrolled or symptomatic hypercalcemia
  • Active, known or suspected autoimmune diseases
  • have received any T cell co stimulation or immune checkpoint therapy
  • Corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug
  • Subjects had active infections
  • Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
  • Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin
  • According to the researcher's judgment, there are other factors that may lead to the termination of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SHR-1210+Paclitaxel-albumin+Carboplatin

    Arm Description

    SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first day of each cycle, with intravenous drip.

    Outcomes

    Primary Outcome Measures

    6-month PFS rate
    PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment

    Secondary Outcome Measures

    Overall Response Rate (ORR)
    Determined using RECIST v1.1 criteria
    Progression-Free Survival(PFS)
    PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
    Overall Survival(OS)
    Defined as the time from randomization to death from any cause
    Number of Subjects with treatment-related adverse events (AEs)
    Incidence, nature, and severity of adverse events graded according to the NCI-CTC AE 5.0

    Full Information

    First Posted
    March 5, 2021
    Last Updated
    March 7, 2021
    Sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04790539
    Brief Title
    a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer
    Official Title
    an Single Arm, Single Center Phase II Clinical Study of Shr-1210 Combined With Paclitaxel-albumin and Carboplatin in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    May 1, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Pulmonary Hospital, Shanghai, China

    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 project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SHR-1210+Paclitaxel-albumin+Carboplatin
    Arm Type
    Experimental
    Arm Description
    SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first day of each cycle, with intravenous drip.
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1210
    Other Intervention Name(s)
    Anti-PD-1 Antibody
    Intervention Description
    SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody
    Primary Outcome Measure Information:
    Title
    6-month PFS rate
    Description
    PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment
    Time Frame
    up to 24 months
    Secondary Outcome Measure Information:
    Title
    Overall Response Rate (ORR)
    Description
    Determined using RECIST v1.1 criteria
    Time Frame
    Up to approximately 24 months
    Title
    Progression-Free Survival(PFS)
    Description
    PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
    Time Frame
    Up to approximately 24 months
    Title
    Overall Survival(OS)
    Description
    Defined as the time from randomization to death from any cause
    Time Frame
    Up to approximately 24 months
    Title
    Number of Subjects with treatment-related adverse events (AEs)
    Description
    Incidence, nature, and severity of adverse events graded according to the NCI-CTC AE 5.0
    Time Frame
    Up to approximately 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: 18 to 75 years old Confirmed diagnosis of Extensive small cell lung cancer Eastern Cooperative Oncology Group performance status (PS) of 0 to 1 The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN have not received first-line systemic therapy or immunosuppressive therapy for es-sclc The estimated survival period is more than 8 weeks The subjects voluntarily joined the study, signed informed consent, Exclusion Criteria: Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI); Leptomeningeal diseases Uncontrolled or symptomatic hypercalcemia Active, known or suspected autoimmune diseases have received any T cell co stimulation or immune checkpoint therapy Corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug Subjects had active infections Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin According to the researcher's judgment, there are other factors that may lead to the termination of the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caicun Zhou, PhD
    Email
    caicunzhoudr@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shengxiang Ren, PhD
    Email
    harry_ren@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer

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