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A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1701; Famitinib
SHR-1701
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
  2. 18 to 75 years old, male or female.
  3. Histologically or cytologically confirmed extensive stage small cell lung cancer(ED-SCLC).
  4. ECOG Performance Status of 0 or 1.
  5. Adequate hematological, hepatic and renal function.
  6. Female subjects of child-bearing potential must have a negative serum HCG test before treatment.

Exclusion Criteria:

  1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
  2. Untreated central nervous system metastases.
  3. Cancerous meningitis (meningeal metastasis).
  4. Uncontrolled pleural effusion, pericardial effusion or ascites.
  5. Tumor infiltration into the great vessels on imaging;
  6. Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
  7. Uncontrolled tumor-related pain.
  8. Malignancies other than SCLC within 5 years.
  9. Systemic antitumor therapy was received 4 weeks prior to trial treatment.
  10. History of autoimmune diseases.
  11. Significant cardiovascular disease.
  12. Inadequately controlled hypertension.
  13. Known history of testing positive test for HIV or known AIDS.
  14. Patients with active hepatitis B or hepatitis C
  15. Severe infections within 4 weeks prior to trial treatment.
  16. Active tuberculosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    SHR-1701+ Famitinib

    SHR-1701

    Arm Description

    Outcomes

    Primary Outcome Measures

    Objective response rate (ORR) based on RECIST 1.1 criteria

    Secondary Outcome Measures

    Progression free survival (PFS) based on RECIST 1.1 criteria
    Disease control rate (DCR) based on RECIST 1.1 criteria
    Duration of response (DoR)
    Overall survival (OS)
    AEs+ SAEs determined by NCI-CTCAE V5.0

    Full Information

    First Posted
    May 7, 2021
    Last Updated
    May 7, 2021
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04884009
    Brief Title
    A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
    Official Title
    An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    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
    The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    SHR-1701 in combination with or without famitinib
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    106 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SHR-1701+ Famitinib
    Arm Type
    Experimental
    Arm Title
    SHR-1701
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1701; Famitinib
    Intervention Description
    SHR-1701+ Famitinib
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1701
    Intervention Description
    SHR-1701
    Primary Outcome Measure Information:
    Title
    Objective response rate (ORR) based on RECIST 1.1 criteria
    Time Frame
    up to approximately 1 year.
    Secondary Outcome Measure Information:
    Title
    Progression free survival (PFS) based on RECIST 1.1 criteria
    Time Frame
    up to approximately 1 year.
    Title
    Disease control rate (DCR) based on RECIST 1.1 criteria
    Time Frame
    up to approximately 1 year.
    Title
    Duration of response (DoR)
    Time Frame
    up to approximately 1 year
    Title
    Overall survival (OS)
    Time Frame
    up to approximately 1 year
    Title
    AEs+ SAEs determined by NCI-CTCAE V5.0
    Time Frame
    Baseline until up to 90 days after end of treatment.

    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: Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form. 18 to 75 years old, male or female. Histologically or cytologically confirmed extensive stage small cell lung cancer(ED-SCLC). ECOG Performance Status of 0 or 1. Adequate hematological, hepatic and renal function. Female subjects of child-bearing potential must have a negative serum HCG test before treatment. Exclusion Criteria: Histologically or cytologically confirmed mixed SCLC and NSCLC. Untreated central nervous system metastases. Cancerous meningitis (meningeal metastasis). Uncontrolled pleural effusion, pericardial effusion or ascites. Tumor infiltration into the great vessels on imaging; Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month. Uncontrolled tumor-related pain. Malignancies other than SCLC within 5 years. Systemic antitumor therapy was received 4 weeks prior to trial treatment. History of autoimmune diseases. Significant cardiovascular disease. Inadequately controlled hypertension. Known history of testing positive test for HIV or known AIDS. Patients with active hepatitis B or hepatitis C Severe infections within 4 weeks prior to trial treatment. Active tuberculosis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Shi
    Phone
    021-68868570
    Email
    wei.shi@hengrui.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Huan Li
    Phone
    17721286513
    Email
    huan.li@hengrui.com

    12. IPD Sharing Statement

    Learn more about this trial

    A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer

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