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).
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
Interventions
Drug | Synonyms | Arms |
---|
SHR-1210 | | SHR-1210+BP102 |
BP102 | | SHR-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
Name | Type | Description | Interventions |
---|
SHR-1210+BP102 | Experimental | Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity. | |
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: | Terminated |
Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
Last Updated
March 17, 2021