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Sintilimab Versus Pembrolizumab for Advanced-stage Non-Small-Cell Lung Cancer

Primary Purpose

Nsclc

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sintilimab
Pembrolizumab
Sponsored by
Guangdong Association of Clinical Trials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nsclc focused on measuring PD-1 inhibitors, immunotherapy, NSCLC, PD-L!

Eligibility Criteria

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

Inclusion Criteria:

  1. Age≥18 years. Signed Informed Consent Form.
  2. Stage IV NSCLC confirmed by histology/ cytology or Stage IIIB-IIIC NSCLC that could not be treated with radical radiation therapy (8th edition of IASLC Lung Cancer Staging System).
  3. Fresh tumor tissue or paraffin tissue within 6 months is adequate for PD-L1 expression (TPS) testing in the central laboratory.
  4. Tumor tissue without EGFR mutation or ALK rearrangement must be confirmed.
  5. Per RECIST 1.1 the efficacy evaluation criteria for solid tumors, at least one radiologically measurable lesion which was not treated with radiotherapy or had obvious disease progression after radiotherapy.
  6. Patients who received no systemic chemotherapy or any other systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.

Exclusion Criteria:

  1. Active hepatitis B. Active hepatitis B is defined as HBsAg positive and the detected HBV-DNA copy number is larger than the upper limit of normal value in the laboratory of the study site.
  2. Currently or prior clinically active interstitial lung disease. Currently active pneumonia. Current radiation pneumonitis for which corticosteroid treatment is required.
  3. Known HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
  4. Fever and the body temperature is above 38°C or clinically significant infection within 1 week prior to the enrollment.
  5. Active tuberculosis. Evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological diseases, seizure, or dementia, unstable or non-compensatory respiratory, cardiovascular, hepatic or renal diseases, and uncontrolled hypertension [CTCAE Grade 2 hypertension or above after drug treatment]).
  6. Patients with active bleeding or new thrombotic diseases who are orally taking with anticoagulant drugs or have bleeding tendency.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    arm 1

    arm 2

    Arm Description

    Patients with PD-L1 high expression (TPS≥50%) receive Sintilimab injection 200mg i.v. on day 1 every three weeks (Q3W). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. Patients with PD-L1 low or negative expression (TPS<50%) receive Sintilimab injection 200mg i.v. in combination with platinum-based chemotherapy every three weeks (Q3W) for 4 cycles. After that, patients receive Sintilimab injection on day 1 Q3W during the maintenance phase (Cycle 5 onward). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity.

    Patients with PD-L1 high expression (TPS≥50%) receive Pembrolizumab injection 200mg i.v. on day 1once every three weeks (Q3W). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. Patients with PD-L1 low or negative expression (TPS<50%) receive Pembrolizumab injection 200mg i.v. in combination with platinum-based chemotherapy every three weeks (Q3W) for 4 cycles. After that, patients receive Pembrolizumab injection on day 1 Q3W during the maintenance phase (Cycle 5 onward). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity.

    Outcomes

    Primary Outcome Measures

    Objective response rate (ORR)
    Defined as the percentage of patients whose tumors have a complete or partial response to treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2020
    Last Updated
    January 31, 2020
    Sponsor
    Guangdong Association of Clinical Trials
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04252365
    Brief Title
    Sintilimab Versus Pembrolizumab for Advanced-stage Non-Small-Cell Lung Cancer
    Official Title
    A Randomized Controlled, Phase II Trial Comparing Sintilimab and Pembrolizumab at First-line Setting in Patients With Advanced Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guangdong Association of Clinical Trials

    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 study is a single-center, randomized controlled, phase II clinical trial, aiming at giving a comparison of Sintilimab and Pembrolizumab in stage IIIB-IV NSCLC patients at first-line treatment setting.
    Detailed Description
    This trial has been set up with two arms. Screened patients would be included into one of the arms based on tumor PD-L1 expression. The purpose of this study is to compare the efficacy of the approved checkpoint inhibitor pembrolizumab and home-made drug Sintilimab in patients with advanced NSCLC whose tumor have high PD-L1 expression and low or negative expression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nsclc
    Keywords
    PD-1 inhibitors, immunotherapy, NSCLC, PD-L!

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    arm 1
    Arm Type
    Experimental
    Arm Description
    Patients with PD-L1 high expression (TPS≥50%) receive Sintilimab injection 200mg i.v. on day 1 every three weeks (Q3W). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. Patients with PD-L1 low or negative expression (TPS<50%) receive Sintilimab injection 200mg i.v. in combination with platinum-based chemotherapy every three weeks (Q3W) for 4 cycles. After that, patients receive Sintilimab injection on day 1 Q3W during the maintenance phase (Cycle 5 onward). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity.
    Arm Title
    arm 2
    Arm Type
    Active Comparator
    Arm Description
    Patients with PD-L1 high expression (TPS≥50%) receive Pembrolizumab injection 200mg i.v. on day 1once every three weeks (Q3W). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. Patients with PD-L1 low or negative expression (TPS<50%) receive Pembrolizumab injection 200mg i.v. in combination with platinum-based chemotherapy every three weeks (Q3W) for 4 cycles. After that, patients receive Pembrolizumab injection on day 1 Q3W during the maintenance phase (Cycle 5 onward). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity.
    Intervention Type
    Drug
    Intervention Name(s)
    Sintilimab
    Other Intervention Name(s)
    IBI308
    Intervention Description
    Given i.v.
    Intervention Type
    Drug
    Intervention Name(s)
    Pembrolizumab
    Other Intervention Name(s)
    Keytruda
    Intervention Description
    Given i.v.
    Primary Outcome Measure Information:
    Title
    Objective response rate (ORR)
    Description
    Defined as the percentage of patients whose tumors have a complete or partial response to treatment
    Time Frame
    Up to 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age≥18 years. Signed Informed Consent Form. Stage IV NSCLC confirmed by histology/ cytology or Stage IIIB-IIIC NSCLC that could not be treated with radical radiation therapy (8th edition of IASLC Lung Cancer Staging System). Fresh tumor tissue or paraffin tissue within 6 months is adequate for PD-L1 expression (TPS) testing in the central laboratory. Tumor tissue without EGFR mutation or ALK rearrangement must be confirmed. Per RECIST 1.1 the efficacy evaluation criteria for solid tumors, at least one radiologically measurable lesion which was not treated with radiotherapy or had obvious disease progression after radiotherapy. Patients who received no systemic chemotherapy or any other systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled. Exclusion Criteria: Active hepatitis B. Active hepatitis B is defined as HBsAg positive and the detected HBV-DNA copy number is larger than the upper limit of normal value in the laboratory of the study site. Currently or prior clinically active interstitial lung disease. Currently active pneumonia. Current radiation pneumonitis for which corticosteroid treatment is required. Known HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation. Fever and the body temperature is above 38°C or clinically significant infection within 1 week prior to the enrollment. Active tuberculosis. Evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological diseases, seizure, or dementia, unstable or non-compensatory respiratory, cardiovascular, hepatic or renal diseases, and uncontrolled hypertension [CTCAE Grade 2 hypertension or above after drug treatment]). Patients with active bleeding or new thrombotic diseases who are orally taking with anticoagulant drugs or have bleeding tendency.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi-Long Wu
    Phone
    13809775415
    Ext
    +86
    Email
    syylwu@live.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qing Zhou
    Phone
    13544561166
    Ext
    +86
    Email
    gzzhouqing@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yi-Long Wu
    Organizational Affiliation
    Guangdong Association of Clinical Trials, GACT
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Sintilimab Versus Pembrolizumab for Advanced-stage Non-Small-Cell Lung Cancer

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