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

NCT03666728 | Terminated Phase 2

• 1 other identifier: SHR-1210-II-211
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Time to Response (TTR)

  up to approximately 1 year

• Duration of Response Rate (DoR)

  up to approximately 1 year

• Disease Control Rate (DCR)

  up to approximately 1 year

• Overall Survival Rate at 12-month (OSR)

  up to 1 year

• Number of participants with treatment-related adverse events (AEs)

  up to approximately 1 year

Study Arms (1)

SHR-1210+BP102

EXPERIMENTAL

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

Drug: SHR-1210; Drug: BP102

Interventions

SHR-1210 DRUG

SHR-1210 was administered 200 mg iv every 3 weeks

SHR-1210+BP102

BP102 DRUG

BP102 was administered 15 mg/kg iv every 3 weeks

SHR-1210+BP102

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiangsu HengRui Medicine Co., Ltd.

  Jiangsu HengRui Medicine Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: November 30, 2018
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

CN (1)