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

Lung Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03666728
• Other study ID #: SHR-1210-II-211
• Status: Terminated
• Phase: Phase 2
• Start date: November 30, 2018
• Est. completion date: March 11, 2020

Study information

• Verified date: March 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Drug:
• SHR-1210
SHR-1210 was administered 200 mg iv every 3 weeks
• BP102
BP102 was administered 15 mg/kg iv every 3 weeks

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to approximately 1 year
Primary	Progression-Free Survival (PFS)	PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.	up to approximately 1 year
Secondary	Time to Response (TTR)	Determined using RECIST v1.1 criteria	up to approximately 1 year
Secondary	Duration of Response Rate (DoR)	Determined using RECIST v1.1 criteria	up to approximately 1 year
Secondary	Disease Control Rate (DCR)	Determined using RECIST v1.1 criteria	up to approximately 1 year
Secondary	Overall Survival Rate at 12-month (OSR)		up to 1 year
Secondary	Number of participants with treatment-related adverse events (AEs)	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.	up to approximately 1 year