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

Phase 2TerminatedNCT03666728

Jiangsu HengRui Medicine Co., Ltd.5 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Neoplasms

Interventions

SHR-1210DRUG

SHR-1210 was administered 200 mg iv every 3 weeks

BP102DRUG

BP102 was administered 15 mg/kg iv every 3 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Objective response rate (ORR)

ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.