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

Launched by SUNHO（CHINA）BIOPHARMACEUTICAL CO., LTD. · Jul 17, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment option for people with small cell lung cancer (SCLC) that has returned after initial treatment. The study is comparing how well a combination of a new drug called IBB0979 plus the chemotherapy drug topotecan works, versus topotecan alone. The goal is to see if adding IBB0979 can improve outcomes and to check if it is safe to use.

People who may be eligible for this study are adults aged 18 to 75 who have a confirmed diagnosis of relapsed small cell lung cancer that has come back or progressed after previous treatments. Participants need to have at least one measurable tumor, be in good overall health with a good performance status, and have a life expectancy of at least three months. Women who join must not be pregnant and must agree to use birth control. During the study, participants will receive either the combination treatment or the standard treatment and will be closely monitored for effectiveness and side effects. It’s important to note that this trial is not yet recruiting patients, and certain health conditions or recent treatments may exclude someone from participating. If you or a loved one is considering this study, discussing eligibility and details with your healthcare provider is a good next step.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged ≥18 and ≤75 years, male or female.
• • 2. Histologically confirmed SCLC.
• • 3. Relapsed small cell lung cancer (limited-stage, extensive-stage) that has failed or progressed after first-line or second-line systemic therapy.
• • 4. At least one measurable lesion according to RECIST version 1.1.
• • 5. ECOG PS 0 or 1.
• • 6. Life expectancy ≥ 3 months.
• • 7. Adequate organ function.
• • 8. Men or women should be using adequate contraceptive measures throughout the study. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
• • 9. Signed and dated Informed Consent Form.
• 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.