NCT03083041

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
BIOLOGICAL	SHR-1210	SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg
DRUG	Apatinib	Apatinib tablet will be administered orally,once daily until progression

Timeline

• Start date: 2017-03-13
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2017-03-17
• Last updated: 2026-03-03
• Results posted: 2026-03-03

Locations

1 site across 1 country: China