At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 62 target
Drug / intervention
HS-10365 capsulesdrug
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.
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
In Brief
A Phase 2 clinical trial evaluating HS-10365 capsules for Nonsmall Cell Lung Cancer. Currently recruiting, targeting 62 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonsmall Cell Lung Cancer
CountriesChina
Collaborators--
Timeline
Phase 2Recruiting
20242025202620272028
Enrollment StartSep 2023
First PostedNov 2023
TodayJul 2026
Primary CompletionAug 2027
Study CompletionAug 2028
First PostedNov 27, 2023
Enrollment StartSep 25, 2023
Primary CompletionAug 31, 2027
Study CompletionAug 31, 2028
TodayJul 1, 2026
Enrollment to primary: 3.9 yearsPosted 2.6 years agoPrimary completion in 1.2 years
Interventions
HS-10365 capsulesdrug
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.