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A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
A Phase II Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung

Clinical Trial 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.

Clinical Trial Description

SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in Apatinib phase II study in patients with NSCLC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03083041
Study type Interventional
Source Jiangsu HengRui Medicine Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date March 22, 2017
Completion date May 20, 2022
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