A Study of SHR-1210 in Combination With Pemetrexed and Carboplatin in Subjects With Non-squamous NSCLC
Status:
Completed
Trial end date:
2019-08-29
Target enrollment:
Participant gender:
Summary
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III,
multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with
carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy
naive and have Stage IIIB/IV non-squamous NSCLC.
The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs
Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review (ITT
population and population was indicated by high PD-L1 expression) compared to carboplatin and
pemetrexed treatment .