Lung Neoplasms
Conditions
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).
Interventions
DRUGSHR-1210
SHR-1210 was administered 200 mg iv every 3 weeks
DRUGBP102
BP102 was administered 15 mg/kg iv every 3 weeks
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | up to approximately 1 year | 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. |
| Progression-Free Survival (PFS) | up to approximately 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | up to approximately 1 year | Determined using RECIST v1.1 criteria |
| Time to Response (TTR) | up to approximately 1 year | Determined using RECIST v1.1 criteria |
| Number of participants with treatment-related adverse events (AEs) | up to approximately 1 year | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03. |
| Overall Survival Rate at 12-month (OSR) | up to 1 year | — |
| Duration of Response Rate (DoR) | up to approximately 1 year | Determined using RECIST v1.1 criteria |
Countries
China
Outcome results
None listed