A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer

Exclusion Criteria

• •1. Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
• •2. Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
• •3. History of anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration.
• •4. History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
• •5. History of major organ surgery (with exception of aspiration biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product administration, or selective operation is required during the trial.
• •6. History of systemic corticosteroid therapy with exceptions defined in the protocol.
• •7. Treatment with immunomodulatory agents, including but not limited to thymosin, interleukin-2 and interferon within 14 days prior to the initiation of investigational product administration.
• •8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.
• •9. History of prior allogeneic stem-cell or solid organ transplantation.
• •10. 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.
• •11. Untreated brain metastases with exceptions defined in the protocol.
• •12. Evidence of active infection requiring intravenous anti-infective therapy.
• •13. Have a history of immune deficiency, including a positive test for human immunodeficiency virus (HIV) antibodies.
• •14. Active hepatitis B, active hepatitis C.
• •15. Currently has interstitial lung disease (with exception of radiation pulmonary fibrosis that requires no hormone therapy).
• •16. History of severe cardiovascular and cerebrovascular diseases.
• •17. Active or suspected autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with exceptions defined in the protocol.
• •18. History of ≥ grade 3 immune-related adverse events (irAE) or Grade 2 immune-associated myocarditis accompanied with immunotherapy with exceptions defined in the protocol.
• •19. History of other malignancy with exceptions defined in the protocol.
• •20. Pleural effusion/peritoneal effusion/Pericardial effusion requiring clinical intervention.
• •21. Known alcohol or drug dependence.
• •22. History of mental disorder or poor adherence.
• •23. The female patient who is pregnant or breastfeeding.
• •24. History of other severe systemic disease, or any issue that in the opinion of the investigator, would contraindicate the patient's participation in the study.