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

Exclusion Criteria25

• Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
• Chemotherapy-free interval ≤30 days.
• Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents.
• Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.
• Has inadequate washout period before randomization as specified in the protocol.
• Untreated or symptomatic brain metastases with exceptions defined in the protocol.
• Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
• History of other malignancy with exceptions defined in the protocol.
• Inadequate bone marrow reserve or organ dysfunction.
• Evidence of cardiovascular risks.
• Severe, uncontrolled or active cardiovascular diseases.
• Severe or uncontrolled diabetes.
• Severe or uncontrolled high blood pressure.
• Clinically significant bleeding or obvious bleeding tendency within 1 month before randomization.
• Severe arterial or venous thromboembolic events within 3 months prior to randomization.
• Severe infections within 4 weeks before randomization.
• Receiving systemic corticosteroid therapy within 30 days prior to randomization with exceptions defined in the protocol.
• The presence of active infectious diseases before randomization.
• Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
• History of interstitial lung disease, immunotherapy-induced pneumonitis, clinically moderate or severe pulmonary disease.
• History of severe neuropathy or mental disorders.
• Female subjects of childbearing potential; female subjects who are breastfeeding or who plan to breastfeed while on study; female subjects planning to become pregnant while on study.
• Vaccination or hypersensitivity of any level within 4 weeks before randomization.
• History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
• Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor or regimens of Topotecan.