A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
NCT03666728 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2021-03-17
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).
Conditions
- Lung Neoplasms
Interventions
- DRUG
-
SHR-1210
SHR-1210 was administered 200 mg iv every 3 weeks
- DRUG
-
BP102
BP102 was administered 15 mg/kg iv every 3 weeks
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jiangsu HengRui Medicine Co., Ltd. · Jiangsu HengRui Medicine Co., Ltd.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-30
- Primary Completion
- 2020-03-11
- Completion
- 2020-03-11
Countries
- China
Study Locations
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