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

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Hengrui Medicine

Status and phase

Terminated
Phase 2

Conditions

Lung Neoplasms

Treatments

Drug: SHR-1210
Drug: BP102

Study type

Interventional

Funder types

Industry

Identifiers

NCT03666728
SHR-1210-II-211

Details and patient eligibility

About

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).

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

SHR-1210+BP102
Experimental group
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.
Treatment:
Drug: BP102
Drug: SHR-1210

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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