At a glance
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A Phase II Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung
In Brief
A Phase 2 clinical trial evaluating SHR-1210 and Apatinib for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 210 participants across 1 site.
Detailed Summary
This is a multi-center, open-label, Phase II study of intravenous (IV) SHR-1210 at 200mg, q2w in combination with Apatinib at two dose levels in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). The study is composed of two parts. Part 1 of the study will determine the safety, tolerability and pharmacokinetics of SHR-1210 in combination with Apatinib. Part 2 includes a randomized comparison of Apatinib 250mg/d or 500mg/d plus SHR-1210. Subject's tumors will be screened at baseline for EGFR mutations, EML4-ALK translocation, and PD-L1 expression.But positive tumor PD-L1 expression will not be required for enrollment.
Study Details
Timeline
Interventions
SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg
Apatinib tablet will be administered orally,once daily until progression