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

NCT ID: NCT03666728

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2020-03-11

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).

Conditions

Lung Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1210+BP102

Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

SHR-1210 was administered 200 mg iv every 3 weeks

BP102

Intervention Type: DRUG

BP102 was administered 15 mg/kg iv every 3 weeks

Interventions

SHR-1210

SHR-1210 was administered 200 mg iv every 3 weeks

Intervention Type: DRUG

BP102

BP102 was administered 15 mg/kg iv every 3 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiangsu HengRui Medicine Co., Ltd.

Role: STUDY_DIRECTOR

Jiangsu HengRui Medicine Co., Ltd.

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

SHR-1210-II-211

Identifier Type: -

Identifier Source: org_study_id