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 study identifier
interventional
62
1 country
1
Study Start
September 25, 2023
Actual (reported)Primary Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2023
Actual (reported)November 17, 2023
Actual (reported)November 27, 2023
Actual (reported)August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
ORR assessed by IRC
ORR is defined as the percentage of patients with a CR or PR that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.
From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study, whichever came first, up to 48 months.
Disease Control Rate (DCR)
From the first occurrence of confirmed CR or PR or SD until the date of disease progression or withdrawal from study, whichever came first, up to 48 months.
Duration of response (DOR)
From the date of the first dose to disease progression or death in patients who achieve CR or PR, whichever came first, up to 48months.
Progression-free survival (PFS)
From the date of the first dose until the date of disease progression or death from any cause, whichever came first, up to 48 months.
Overall survival (OS)
The time from initial administration to death from any cause, up to 5 years.
Incidence and severity of treatment-related adverse events
From the first dose until 28 days after the last dose
160 mg BID of HS-10365
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shun Lu, MD
Shanghai Chest Hospital
First Submitted
November 17, 2023
First Posted
November 27, 2023
Study Start
September 25, 2023
Actual (reported)Primary Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 27, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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