Trials / Terminated
TerminatedNCT03666728
A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
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.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-11-30
- Primary completion
- 2020-03-11
- Completion
- 2020-03-11
- First posted
- 2018-09-12
- Last updated
- 2021-03-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03666728. Inclusion in this directory is not an endorsement.