A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy Progression

Inclusion Criteria

• •1. Age 18 to 75 years (inclusive), male or female.
• •2. Histologically confirmed small cell lung cancer (SCLC).
• •3. Extensive-stage SCLC refractory to 2 to 3 prior lines of systemic anti-tumor therapy, which must have included PD-1/PD-L1 immunotherapy.
• •4. At least one measurable target lesion as per RECIST 1.1 criteria. The target lesion must be measurable (longest diameter ≥10 mm at baseline, or for lymph nodes, short-axis diameter ≥15 mm) and not have been previously irradiated, or have demonstrated clear progression after local therapy. Lesions solely within the brain are not acceptable as target lesions.
• •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• •6. Life expectancy ≥ 3 months.
• •7. Adequate organ function,
• •8. Fertile patients (male and female) must agree to use highly effective contraception (e.g., hormonal, barrier methods, or abstinence) with their partner during the trial and for at least 6 months after the last dose. A serum pregnancy test for women of childbearing potential must be negative within 7 days prior to the first study dose.
• •9. Subjects must provide written informed consent before initiating any study-specific procedures.
• •10. Active infection requiring intravenous anti-infective therapy at the time of screening.
• •11. History of immunodeficiency, including a positive test for human immunodeficiency virus (HIV).
• •12. Active hepatitis B (HBsAg positive and HBV-DNA ≥1000 IU/mL or copies/mL) or active hepatitis C (HCV antibody positive and HCV RNA above the upper limit of normal).
• •13. Interstitial lung disease (except for radiation-induced fibrosis not requiring corticosteroid therapy).
• •14. Significant cardiovascular and cerebrovascular disease history
• •15. Active autoimmune disease, or history of autoimmune disease with potential for recurrence (exceptions include well-controlled autoimmune thyroiditis, type I diabetes, vitiligo, childhood atopic dermatitis resolved, psoriasis not requiring systemic therapy in the past 2 years, etc.).
• •16. Prior history of ≥ Grade 3 immune-related adverse event (irAE) or ≥ Grade 2 immune-related myocarditis associated with prior immunotherapy.
• •17. History of other malignancies, except for those cured for ≥2 years, such as non-melanoma skin cancer, localized prostate cancer, or carcinoma in situ (e.g., cervical carcinoma in situ).
• •18. Pleural effusion or ascites requiring therapeutic intervention (subjects with stable effusion not requiring drainage or stable for ≥1 week after drainage may be eligible); pericardial effusion (asymptomatic, minimal effusion not requiring intervention per investigator's assessment is allowed). If intra-cavitary anti-tumor agents were used during drainage, a washout period of at least 5 half-lives or 21 days (whichever is shorter) must be completed prior to the first dose.
• •19. Known history of alcohol or drug dependence.
• •20. History of psychiatric disorders or anticipated poor compliance.
• •21. Pregnancy or lactation.
• •22. Any other condition deemed by the investigator to potentially compromise the subject's safety or compliance, or make the subject unsuitable for the study.