NCT06498479

ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer

ARTEMIS-008：A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HS-20093	HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle.
DRUG	Topotecan	Topotecan will be administered per drug label.

Timeline

• Start date: 2024-07-04
• Primary completion: 2026-09-30
• Completion: 2027-05-31
• First posted: 2024-07-12
• Last updated: 2024-10-16

Locations

9 sites across 1 country: China

Regulatory

• FDA-regulated drug study