CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
SHR-1210 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03417895
NCT03417895Phase 2Completed

Anti-PD-1 Antibody SHR-1210 Combined With Anti-angiogenesis Inhibitor Apatinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy

Jiangsu HengRui Medicine Co., Ltd.·interventional·Posted Jan 31, 2018·Updated Aug 7, 2024

In Brief

A Phase 2 clinical trial evaluating SHR-1210 and Apatinib for Small-cell Lung Cancer. Completed, enrolled 59 participants across 2 sites.

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 one dose (375mg). Comparison of 3 different dose schedules in subjects with extensive-stage disease small cell lung cancer. 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). The study is composed of two parts. Part 1 of the study will determine the safety and tolerability of SHR-1210 in combination with Apatinib in first 6 subjects of each arm. The second phase of treatment was carried out by selecting one group of administration mode and the tolerated dose of Apatinib. Part 2 of the study will determine the safety and efficacy of SHR-1210 in combination with Apatinib in 39 subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 31, 2018
Enrollment StartApr 20, 2018
Primary CompletionAug 4, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.4 years ago

Interventions

SHR-1210drug

A humanized anti-PD-1 monoclonal antibody

Apatinibdrug

A tyrosine kinase inhibitor selectively targeting VEGFR-2