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Clinical Trial Summary

HS-10365 is a small molecular, oral potent, selective RET inhibitor. The purpose of this study is to investigate the efficacy and safety of HS-10365 in Chinese advanced RET fusion-positive non-small cell lung cancer patients without any systemic therapy.


Clinical Trial Description

This is an open-label, single arm, multi-center Phase 2 study in participants with treatment-naïve locally advanced or metastatic RET fusion-positive non-small cell lung cancer, which is designed to investigate the anti-tumor activity, safety and pharmacokinetics (PK) of HS-10365 at the recommended phase 2 dose (RP2D). HS-10365 will be administered orally twice daily until the occurrence of disease progression, unacceptable adverse events, withdrawal of consent, death or the end of the study. Primary endpoint is objective response rate (ORR) by Independent Reading Committee (IRC). Secondary and exploratory objectives include evaluation of secondary efficacy endpoints, safety and PK in the study population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06147570
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact Shun Lu, MD
Phone 13601813062
Email shun_lu@hotmail.com
Status Recruiting
Phase Phase 2
Start date September 25, 2023
Completion date August 31, 2028

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