A Phase 3 interventional study of HS-20093 and Topotecan in Small Cell Lung Cancer, sponsored by Hansoh BioMedical R&D Company. Recruiting at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Hansoh BioMedical R&D Company · Phase 3, Interventional, and Treatment
The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).
This is a phase 3, randomized, open-label, multicenter study comparing HS-20093 with topotecan in patients with limited or extensive SCLC that had disease progression on or after first-line platinum-based regimen. Subjects will be randomized by a ratio of 1:1 to receive HS-20093 or topotecan until disease progression.
The primary objective of this study is to assess whether treatment with HS-20093 prolongs OS compared with treatment of topotecan among subjects with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy/safety of HS-20093. The exploratory objectives are to characterize the pharmacokinetics of HS-20093, evaluate E-R relationship, immunogenicity of HS-20093, B7-H3 protein expression and soluble B7-H3 expression.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 460 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hansoh BioMedical R&D Company is the lead sponsor of 44 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Participants will receive HS-20093 as an intravenous (IV) infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle until a treatment discontinuation criterion is met as specified in the protocol.
Drug: HS-20093
Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol.
Drug: Topotecan
HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle.
Topotecan will be administered per drug label.
Overall survival
Overall survival is defined as the time interval from randomization to death due to any cause.
Time frame: From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigators
Confirmed ORR is defined as the sum of the complete response (CR) rate and partial response (PR) rate as per BICR and investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Disease Control Rate (DCR) Assessed by Blinded Independent Central Review and Investigator
Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per BICR and investigator assessment per RECIST v1.1.
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Duration of Response Assessed by Blinded Independent Central Review and Investigator
Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death.
Time frame: From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first; Up to approximately 4.5 years.
Progression-free Survival Assessed by Blinded Independent Central Review and Investigator
PFS is defined as the time interval from the randomization to disease progression as per BICR and investigator assessment or death due to any cause.
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Incidence and Grade of Participants With Treatment-emergent Adverse Events
TEAEs are assessed based on NCI CTCAE v5.0.
Time frame: From the date of first dose to the end of safety follow-up; Up to approximately 4.5 years.
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Hansoh BioMedical R&D Company