Clinical Trials /

A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC

NCT03666728

Description:

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB~IV non-squamous NSCLC. The primary end points are ORR and PFS. In this study, subjects will receive SHR-1210 combined with BP102 until progression or unacceptable toxicity (SHR-1210 or BP102 for a maximum of 2 years).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
  • Official Title: An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210 Combination With BP102 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Whose PD-L1 Positive and EGFR/ALK Wild Type.

Clinical Trial IDs

  • ORG STUDY ID: SHR-1210-II-211
  • NCT ID: NCT03666728

Conditions

  • Lung Neoplasms

Interventions

DrugSynonymsArms
SHR-1210SHR-1210+BP102
BP102SHR-1210+BP102

Purpose

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB~IV non-squamous NSCLC. The primary end points are ORR and PFS. In this study, subjects will receive SHR-1210 combined with BP102 until progression or unacceptable toxicity (SHR-1210 or BP102 for a maximum of 2 years).

Trial Arms

NameTypeDescriptionInterventions
SHR-1210+BP102ExperimentalSubjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity.
  • SHR-1210
  • BP102

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;

          -  Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC;

          -  Gene diagnostic tests must show that subjects are with wild type of EGFR, ALK and
             ROS1;

          -  Known PD-L1 status as determined by immunohistochemistry assay performed on previously
             obtained archival tumor tissue or tissue obtained from a biopsy at screening;

          -  No prior systemic treatment;

          -  Adequate hematologic and end organ function;

          -  Female participants of childbearing potential must have a negative serum pregnancy
             test within -7 days of randomization and must be willing to use very efficient barrier
             methods of contraception or a barrier method plus a hormonal method starting with the
             screening visit through 6 months after the last dose Male participants with a female
             partner(s) of child-bearing potential must be willing to use very efficient barrier
             methods of contraception from screening through 6 months after the last dose.

        Exclusion Criteria:

          -  Significant cardiovascular disease;

          -  Prior treatment with immune checkpoint blockade therapies, anti-programmed death-1,
             and anti-PD-L1 therapeutic antibodies;

          -  History of autoimmune disease;

          -  Malignancies other than NSCLC within 5 years prior to randomization, with the
             exception of those with a negligible risk of metastasis or death treated with expected
             curative outcome;

          -  Severe infection within 4 weeks prior to randomization;

          -  Administration of a live, attenuated vaccine within 4 weeks before randomization or
             anticipation that such a live attenuated vaccine will be required during the study;

          -  Major surgical procedure within 4 weeks prior to randomization;

          -  History of hemoptysis within 12 weeks prior to randomization;

          -  Inadequately controlled hypertension;

          -  Evidence of bleeding diathesis or coagulopathy;

          -  Prior allogeneic bone marrow transplantation or solid organ transplant;

          -  Positive test for HIV, and patients with active hepatitis B or hepatitis C.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:up to approximately 1 year
Safety Issue:
Description:ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

Secondary Outcome Measures

Measure:Time to Response (TTR)
Time Frame:up to approximately 1 year
Safety Issue:
Description:Determined using RECIST v1.1 criteria
Measure:Duration of Response Rate (DoR)
Time Frame:up to approximately 1 year
Safety Issue:
Description:Determined using RECIST v1.1 criteria
Measure:Disease Control Rate (DCR)
Time Frame:up to approximately 1 year
Safety Issue:
Description:Determined using RECIST v1.1 criteria
Measure:Overall Survival Rate at 12-month (OSR)
Time Frame:up to 1 year
Safety Issue:
Description:
Measure:Number of participants with treatment-related adverse events (AEs)
Time Frame:up to approximately 1 year
Safety Issue:
Description:Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Jiangsu HengRui Medicine Co., Ltd.

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