At a glance
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A Phase III, Randomized, Open-Label, Multi-center Study of SHR-1210(Anti-PD-1 Antibody) in Combination With Pemetrexed and Carboplatin as First Line Therapy in Subjects With Advanced/Metastatic Non-squamous Non-small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating SHR-1210, Carboplatin, and 1 other intervention for Lung Neoplasms and 8 related conditions. Completed, enrolled 419 participants across 1 site.
Detailed 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 .
Study Details
Timeline
Interventions
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Carboplatin
Pemetrexed