ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. Male or female subjects ≥18 years of age. 2. Histologically or cytologically confirmed SCLC. 3. Subjects who progressed on or after first-line platinum-based regimens. 4. Has at least 1 measurable lesion as defined per RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. Minimum life expectancy of more than 12 weeks. 7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. 8. Men or women should be using adequate contraceptive measures throughout the study. 9. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures. Exclusion Criteria: 1. Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC. 2. Chemotherapy-free interval ≤30 days. 3. Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents. 4. Has received prior treatment with topoisomerase I inhibitor, including ADC tha