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

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.