RecruitingPhase 2NCT06147570

A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

A Phase II, Open-label, Multicenter Study to Evaluate the Efficacy,Safety and Pharmacokinetics of HS-10365 as First-Line Treatment for Patients With Locally Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

62 participants

Start Date

Sep 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new targeted drug called HS-10365 specifically for people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic alteration called a RET gene fusion — a change where the RET gene abnormally joins with another gene, causing uncontrolled cancer growth. **You may be eligible if...** - You are 18 or older with advanced or metastatic lung cancer (NSCLC) confirmed by biopsy - Your tumor has a confirmed RET gene fusion - Your cancer is not suitable for surgery - You have at least one measurable tumor on imaging - Your life expectancy is more than 12 weeks - You have not had prior treatment for metastatic lung cancer **You may NOT be eligible if...** - You have had prior treatment targeting the RET gene - You have had prior systemic (body-wide) therapy for metastatic disease - Your cancer has another known primary driver mutation (like EGFR, ALK) - You have active or uncontrolled brain metastases - You have active autoimmune disease or a serious uncontrolled infection - You have serious heart problems, nausea that cannot be controlled, or severe GI disease - You are pregnant or breastfeeding - You have epilepsy, dementia, or significant nerve damage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-10365 capsules

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.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06147570


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