Status:
COMPLETED
A Study of SHR-1316 and Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of SHR-1316 in combination with Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients
Eligibility Criteria
Inclusion
- Patients must be at least 18 years of age.
- Histologically or cytologically confirmed SCLC.
- Failed at least one prior line of platinum-based chemotherapy.
- Patients must have measurable disease as defined by RECIST v1.1.
- ECOG 0-1.
- Adequate hematologic and organ function
- Signed inform consent form
Exclusion
- Active or untreated central nervous system (CNS) metastases
- Spinal cord compression not definitively treated with surgery and/or radiation .
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Malignancies other than SCLC within 5 years prior to randomization
- History of autoimmune disease
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Severe infections
- Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.
- Significant cardiovascular disease
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Treatment with systemic immunosuppressive medications prior to randomization
- Pregnant or lactating women
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04041011
Start Date
September 17 2019
End Date
April 23 2021
Last Update
June 21 2022
Active Locations (1)
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1
Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005