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A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer

Primary Purpose

Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
Sponsored by
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

-

A subject must satisfy all of the following criteria to be considered for inclusion in the study:

  1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
  2. Failed with prior EGFR-TKIs treatments.
  3. Measurable disease, as defined by RECIST v1.1
  4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
  5. Life expectancy ≥ 3 months
  6. Adequate hematologic and end-organ function as defined in the protocol

Exclusion Criteria:

-

A subject who meets any of the following criteria will be excluded from study entry:

  1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
  2. Symptomatic, untreated or active central nervous system metastases.
  3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
  4. With any active autoimmune disease or history of autoimmune disease.
  5. Inadequately controlled hypertension.
  6. Tumour infiltration into the great vessels on imaging.
  7. History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
  8. Uncontrolled tumour-related pain.
  9. Patients with active hepatitis B or hepatitis C
  10. Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    treatment group

    Placebo group 1

    Placebo group 2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I）
    BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）

    Secondary Outcome Measures

    Progression free survival (PFS)（Stage I）
    Objective response rate (ORR)（Stage I）
    Disease control rate (DCR) （Stage I）
    Duration of response (DOR) （Stage I）
    Overall survival (OS) （Stage I）
    Progression free survival (PFS)（Stage II）
    Objective response rate (ORR)（Stage II）
    Disease control rate (DCR)（Stage II）
    Duration of response (DOR) （Stage II）
    Overall survival (OS) （Stage II）
    Incidence and severity of adverse events (AEs), serious adverse events （Stage II）
    (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II）

    Full Information

    First Posted
    November 12, 2021
    Last Updated
    November 12, 2021
    Sponsor
    Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05132413
    Brief Title
    A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer
    Official Title
    A Phase 3, Randomized Double-blind, Placebo-controlled, Multicenter Study of SHR-1701 in Combination With Bevacizumab and Chemotherapy in Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer With EGFR Mutation After Failure of TKIs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 30, 2021 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Suzhou Suncadia Biopharmaceuticals 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
    Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    SHR-1701/ Placebo Plus Chemotherapy With or Without Bevacizumab
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    561 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Arm Title
    Placebo group 1
    Arm Type
    Placebo Comparator
    Arm Title
    Placebo group 2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
    Intervention Description
    SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
    Intervention Description
    Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
    Intervention Description
    Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
    Primary Outcome Measure Information:
    Title
    Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I）
    Time Frame
    2 years
    Title
    BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Progression free survival (PFS)（Stage I）
    Time Frame
    2 years
    Title
    Objective response rate (ORR)（Stage I）
    Time Frame
    2 years
    Title
    Disease control rate (DCR) （Stage I）
    Time Frame
    2 years
    Title
    Duration of response (DOR) （Stage I）
    Time Frame
    2 years
    Title
    Overall survival (OS) （Stage I）
    Time Frame
    2 years
    Title
    Progression free survival (PFS)（Stage II）
    Time Frame
    2 years
    Title
    Objective response rate (ORR)（Stage II）
    Time Frame
    2 years
    Title
    Disease control rate (DCR)（Stage II）
    Time Frame
    2 years
    Title
    Duration of response (DOR) （Stage II）
    Time Frame
    2 years
    Title
    Overall survival (OS) （Stage II）
    Time Frame
    2 years
    Title
    Incidence and severity of adverse events (AEs), serious adverse events （Stage II）
    Time Frame
    2 years
    Title
    (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II）
    Time Frame
    2 years

    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: - A subject must satisfy all of the following criteria to be considered for inclusion in the study: Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer. Failed with prior EGFR-TKIs treatments. Measurable disease, as defined by RECIST v1.1 The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1 Life expectancy ≥ 3 months Adequate hematologic and end-organ function as defined in the protocol Exclusion Criteria: - A subject who meets any of the following criteria will be excluded from study entry: Histologically or cytologically confirmed mixed SCLC and NSCLC. Symptomatic, untreated or active central nervous system metastases. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment With any active autoimmune disease or history of autoimmune disease. Inadequately controlled hypertension. Tumour infiltration into the great vessels on imaging. History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment. Uncontrolled tumour-related pain. Patients with active hepatitis B or hepatitis C Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuanchao Wang
    Phone
    0518-81220278
    Email
    yuanchao.wang@hengrui.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    You Li
    Phone
    0518-81220278
    Email
    you.li.yl1@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer

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