Back to resultsA Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
Primary Purpose
Lung Neoplasms
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210
BP102
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms
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.
Sites / Locations
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-1210+BP102
Arm Description
Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
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.
Progression-Free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Secondary Outcome Measures
Time to Response (TTR)
Determined using RECIST v1.1 criteria
Duration of Response Rate (DoR)
Determined using RECIST v1.1 criteria
Disease Control Rate (DCR)
Determined using RECIST v1.1 criteria
Overall Survival Rate at 12-month (OSR)
Number of participants with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Full Information
NCT ID
NCT03666728
First Posted
September 10, 2018
Last Updated
March 15, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03666728
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
changes in the R&D strategy
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR-1210+BP102
Arm Type
Experimental
Arm Description
Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Intervention Description
SHR-1210 was administered 200 mg iv every 3 weeks
Intervention Type
Drug
Intervention Name(s)
BP102
Intervention Description
BP102 was administered 15 mg/kg iv every 3 weeks
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
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.
Time Frame
up to approximately 1 year
Title
Progression-Free Survival (PFS)
Description
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Time Frame
up to approximately 1 year
Secondary Outcome Measure Information:
Title
Time to Response (TTR)
Description
Determined using RECIST v1.1 criteria
Time Frame
up to approximately 1 year
Title
Duration of Response Rate (DoR)
Description
Determined using RECIST v1.1 criteria
Time Frame
up to approximately 1 year
Title
Disease Control Rate (DCR)
Description
Determined using RECIST v1.1 criteria
Time Frame
up to approximately 1 year
Title
Overall Survival Rate at 12-month (OSR)
Time Frame
up to 1 year
Title
Number of participants with treatment-related adverse events (AEs)
Description
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Time Frame
up to approximately 1 year
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiangsu HengRui Medicine Co., Ltd.
Organizational Affiliation
Jiangsu HengRui Medicine Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
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