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A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
QL1706
Tilesizumab
Sponsored by
Qilu Pharmaceutical 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: Be≥18 to ≤ 75 years of age at enrollment, male or female. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer [AJCC] 8th edition). No EGFR sensitive mutations or ALK gene translocation alterations. Capable of providing fresh or archived 2 years' tissue samples collected at post-diagnosis or non-radiation sites at diagnosis for central laboratory PD-L1 testing with TPS < 1% . Have a life expectancy of at least 3 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. No prior systemic therapy for advanced or metastatic NSCLC was received. Exclusion Criteria: Previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 drugs or drugs acting on another T cell receptor (e.g., CTLA-4 etc.), as well as immune checkpoint agonistic antibodies (e.g., anti ICOS , CD40 , CD137 , GITR , OX40 antibodies, etc.), and immune cell therapy. Patients who have received systemic corticosteroids or other immunosuppressive drugs within 2 weeks prior to the first dose. Presence or history of any active autoimmune disease, including, but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism. Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose; Palliative radiotherapy completed 7 days prior to first dose. Known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis during screening. Clinically significant cardiovascular or cerebrovascular disease -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    QL1706+chemotherapy

    Tiselizumab+chemotherapy

    Arm Description

    Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive QL1706, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706 or QL1706 combined with pemetrexed.

    Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive tiselizumab, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with tiselizumab or tiselizumab combined with pemetrexed.

    Outcomes

    Primary Outcome Measures

    PFS
    Progression Free Survival in the intent to treat (ITT) population, as determined by the investigator according to RECIST v1.1 criteria
    OS
    Overall Survival (OS) in the ITT population determined by the investigator

    Secondary Outcome Measures

    ORR
    Objective Response Rate assessed by investigator according to RECIST v1.1 criteria
    DOR
    Duration of Response assessed by investigator according to RECIST v1.1 criteria
    DCR
    Disease Control Rate assessed by investigator according to RECIST v1.1 criteria

    Full Information

    First Posted
    January 10, 2023
    Last Updated
    January 10, 2023
    Sponsor
    Qilu Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05690945
    Brief Title
    A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer
    Official Title
    A Randomized, Double-blind, Multicenter Phase 3 Clinical Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Chemotherapy in First-line PD-L1 Negative, Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    June 23, 2025 (Anticipated)
    Study Completion Date
    June 23, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Qilu Pharmaceutical Co., Ltd.

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy in PD-L1 negative, locally advanced or metastatic Non-small Cell Lung Cancer Patients. The subjects were randomly divided into two groups according to 1:1, with about 325 subjects in the experimental group and the control group.
    Detailed Description
    This study was a randomized, double-blind, active-controlled, multicenter Phase 3 clinical study. The study is designed to evaluate the efficacy and safety of QL1706 in combination with chemotherapy or commercial PD1 in combination with chemotherapy in locally advanced or metastatic NSCLC patients who are PD-L1 negative.650 patients would be enrolled . Subjects will be assigned randomly in a 1:1 ratio to experimental group and control group. Subjects will be stratified by pathological type: squamous cell carcinoma versus non-squamous cell carcinoma; brain metastasis: present versus absent; gender: male versus female. After randomization, subjects will be treated according to the randomization results.

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    650 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    QL1706+chemotherapy
    Arm Type
    Experimental
    Arm Description
    Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive QL1706, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706 or QL1706 combined with pemetrexed.
    Arm Title
    Tiselizumab+chemotherapy
    Arm Type
    Active Comparator
    Arm Description
    Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive tiselizumab, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with tiselizumab or tiselizumab combined with pemetrexed.
    Intervention Type
    Drug
    Intervention Name(s)
    QL1706
    Other Intervention Name(s)
    PSB205
    Intervention Description
    QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.
    Intervention Type
    Drug
    Intervention Name(s)
    Tilesizumab
    Other Intervention Name(s)
    BGB-108
    Intervention Description
    Tilesizumab will be administered by IV infusion at 200mg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    Progression Free Survival in the intent to treat (ITT) population, as determined by the investigator according to RECIST v1.1 criteria
    Time Frame
    Informed consent until disease progression or death, which ever occurs first (up to approximately 2 years)
    Title
    OS
    Description
    Overall Survival (OS) in the ITT population determined by the investigator
    Time Frame
    From date of randomization until the date of death from any cause, which ever came first, assessed up to 2 years
    Secondary Outcome Measure Information:
    Title
    ORR
    Description
    Objective Response Rate assessed by investigator according to RECIST v1.1 criteria
    Time Frame
    First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
    Title
    DOR
    Description
    Duration of Response assessed by investigator according to RECIST v1.1 criteria
    Time Frame
    First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
    Title
    DCR
    Description
    Disease Control Rate assessed by investigator according to RECIST v1.1 criteria
    Time Frame
    First administration until disease progression or death, which ever occurs first (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: Be≥18 to ≤ 75 years of age at enrollment, male or female. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer [AJCC] 8th edition). No EGFR sensitive mutations or ALK gene translocation alterations. Capable of providing fresh or archived 2 years' tissue samples collected at post-diagnosis or non-radiation sites at diagnosis for central laboratory PD-L1 testing with TPS < 1% . Have a life expectancy of at least 3 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. No prior systemic therapy for advanced or metastatic NSCLC was received. Exclusion Criteria: Previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 drugs or drugs acting on another T cell receptor (e.g., CTLA-4 etc.), as well as immune checkpoint agonistic antibodies (e.g., anti ICOS , CD40 , CD137 , GITR , OX40 antibodies, etc.), and immune cell therapy. Patients who have received systemic corticosteroids or other immunosuppressive drugs within 2 weeks prior to the first dose. Presence or history of any active autoimmune disease, including, but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism. Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose; Palliative radiotherapy completed 7 days prior to first dose. Known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis during screening. Clinically significant cardiovascular or cerebrovascular disease -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lianghua Fang
    Phone
    86-13645192882
    Email
    lianghua.fang@qilu-pharma.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li Zhang, Professor
    Organizational Affiliation
    Sun Yat-sen Univeisity Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer

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