Clinical trial NCT03666728: A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Neoplasms
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to approximately 1 year
measure: Progression-Free Survival (PFS)
timeFrame: up to approximately 1 year
Secondary outcomes:
measure: Time to Response (TTR)
timeFrame: up to approximately 1 year
measure: Duration of Response Rate (DoR)
timeFrame: up to approximately 1 year
measure: Disease Control Rate (DCR)
timeFrame: up to approximately 1 year
measure: Overall Survival Rate at 12-month (OSR)
timeFrame: up to 1 year
measure: Number of participants with treatment-related adverse events (AEs)
timeFrame: up to approximately 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Jiangsu HengRui Medicine Co., Ltd.
name: Jiangsu HengRui Medicine Co., Ltd.
role: STUDY_DIRECTOR
References: