A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer
NCT Number: NCT06526624
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Limited-stage Small-cell Lung Cancer
Interventions: DRUG: HS-20093
Sponsor: Hansoh BioMedical R&D Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 406
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2029-01-31

Summary:
This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.

Primary Outcome Measures: Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC), To assess the efficacy of HS-20093 vs active surveillance in terms of PFS. PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1., Approximately 6 years|Overall survival (OS), To assess the efficacy of HS-20093 vs active surveillance in terms of OS. Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause., Approximately 6 years
Secondary Outcome Measures: PFS at 12 Months (PFS12) or 18 Months (PFS18) According to RECIST v1.1 by IRC, PFS12 and PFS18 are defined as the progression-free survival at 12 months and 18 months from the date of randomization, respectively, based on IRC using RECIST v1.1., Approximately 6 years.|ORR According to RECIST v1.1 by IRC, ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1, From the date of randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.|DCR According to RECIST v1.1 by IRC, DCR is deﬁned as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease), From the date of randomization until the date of disease progression or withdrawal from study, approximately 6 years.|DoR by IRC, DoR only applies to participants whose best overall response is CR or PR. The start date is the date of first documented response of CR or PR, and the end date is defined as the date of the first documented progression or death due to underlying disease., From the date of CR, PR until the date of disease progression or death, approximately 6 years.|PFS According to RECIST v1.1 by investigators (INVs), PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on INVs using RECIST v1.1, Approximately 6 years.|PFS12 or PFS18 According to RECIST v1.1 by INVs, PFS12 and PFS18 are defined as the progression-free survival at 12 months and 18 months from the date of randomization, respectively, based on INVs using RECIST v1.1., Approximately 6 years.|ORR According to RECIST v1.1 by INVs, ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1 by INVs., From the randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.|DCR According to RECIST v1.1 by INVs, DCR is deﬁned as the percentage of patients who have a best overall response (CR, PR, or stable disease)., From the randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.|DoR According to RECIST v1.1 by INVs, DoR is deﬁned as the percentage of patients who have a best overall response (CR, PR, or stable disease)., From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 6 years.|Proportion of patients alive at 24 months (OS24) or 36 months (OS36), OS24 and OS36 are defined as the proportion of patients alive at 24 months and 36 months from the date of randomization, respectively, based on INVs using RECIST v1.1., Approximately 6 years.|Incidence and severity of treatment-emergent adverse events, Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant without regard to possibility of causal relationship., From the date of first dose until 90 days after the final dose. A cycle is 21 days.