A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer

This is a randomized, controlled, open-label, multi-center, phase III clinical study to evaluate the efficacy and safety of HS-20093 versus active surveillance as consolidation therapy in participants with limited-stage small cell lung cancer (LS-SCLC) who have not progressed after receiving chemoradiotherapy (CRT).

This study consists of an experimental arm and a control arm. The experimental arm will be administered HS-20093, and the control arm will only receive active surveillance. Efficacy and safety were assessed in both arms by follow-up analyses.

Inclusion criteria

• Have signed Informed Consent Form.
• Males or females ≥18 years old.
• Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery.
• ECOG performance status of 0-1.
• Patients who have received CRT and have not progressed.
• Minimum life expectancy > 12 weeks.
• Males or Females should be using adequate contraceptive measures throughout the study.
• Females must not be pregnant at screening or have evidence of non-childbearing potential.

Exclusion criteria

• Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma.
• Patients with extensive-stage SCLC.
• Disease progression during CRT or before randomization.
• Received or are receiving the following treatments:

• For LS-SCLC, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide
• Received any other anti-cancer treatment.
• Previous or current treatment with B7-H3 target therapy.
• Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug.
• Major surgery within 4 weeks prior to the first dose of study drug.
• Interstitial lung disease (ILD)/non-infectious pneumonitis.
• History of other primary malignancies.
• Inadequate bone marrow reserve or organ functions.
• Severe, uncontrolled or active cardiovascular disorders.
• Severe or uncontrolled diabetes.
• Serious or poorly controlled hypertension.
• Severe bleeding symptoms or bleeding tendencies within 1 month prior to randomization.
• Severe arteriovenous thrombosis occurred within 3 months prior to randomization.
• Serious infection within 4 weeks prior to randomization.
• Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
• Having serious neurological or mental disorders.
• History of hypersensitivity to any component of HS-200093 or its similar drugs.
• Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.