Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jiangsu HengRui Medicine Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC