Status:
COMPLETED
SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Small-cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a multi-center, open-label, phase II study of intravenous (IV) SHR-1210 at 200mg,q2w in combination with Apatinib at one dose (375mg). Comparison of 3 different dose schedules in subjects with...
Eligibility Criteria
Inclusion
- Signed inform consent form.
- Age \>= 18 years and \<= 70 years.
- Histologically or cytologically confirmed small cell lung cancer.
- ED-SCLC according to Veterans Administration Lung Study Group.
- Radiographically progression following a platinum-based standard prior chemotherapy regimen.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Measurable disease as defined by RECIST v1.1.
- Life expectancy \>= 8 weeks.
- Adequate hematologic and end organ function.
Exclusion
- Histologically or cytologically confirmed mixed non-small cell and small cell carcinoma.
- Prior exposure to therapeutic anticancer vaccines; prior exposure to any T cell co-stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies.
- Prior exposure to anti-VEGF or anti-VEGFR therapy.
- Active brain metastasis or meningeal metastasis.
- Clinically significant third space effusion (e.g., uncontrolled pericardial effusion, ascites or pleural effusion by extraction or other treatment).
- Known hypersensitivity to study drug or any of its excipients; known hypersensitivity to any antibody.
- Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to screening.
- Other conditions that the investigator thinks unsuitable in this study.
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2021
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03417895
Start Date
April 20 2018
End Date
August 4 2021
Last Update
August 7 2024
Active Locations (2)
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1
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022