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
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female subjects ≥18 years of age.
• Histologically or cytologically confirmed SCLC.
• Subjects who progressed on or after first-line platinum-based regimens.
• Has at least 1 measurable lesion as defined per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Minimum life expectancy of more than 12 weeks.
• Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
• Men or women should be using adequate contraceptive measures throughout the study.
• Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Locations
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
The First Affiliate Hospital of GUANGZHOU Medical University
NOT_YET_RECRUITING
Guangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Tongji Hospital
NOT_YET_RECRUITING
Wuhan
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Time Frame
Start Date:2024-07-04
Estimated Completion Date:2027-05-31
Participants
Target number of participants:460
Treatments
Experimental: HS-20093
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.
Active_comparator: Topotecan
Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol.