A Phase II Clinical Study of SHR-7787 Injection Combined With SHR-1316 Injection in Patients With LS-SCLC

A Multicenter, Open-label, Phase Ⅱ Clinical Study of SHR-7787 Injection Combined With Adebrelimab in Patients With Limited Stage Small Cell Lung Cancer

This study is an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer.

Inclusion Criteria:

1. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.
2. Aged 18 to 75 years (inclusive), of any gender.
3. Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy.
4. ECOG performance status score of 0 or 1.
5. Estimated survival time of more than 3 months.
6. Have adequate bone marrow and organ function.
7. Female trial participants of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug, and avoid donating eggs.

Exclusion Criteria:

1. Combined small cell lung cancer or any transformed small cell lung cancer.
2. History of other malignancies within 5 years prior to the first dose of the study drug.
3. Severe cardiovascular or cerebrovascular diseases.
4. Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug.
5. Malignant pleural effusion or malignant pericardial effusion.
6. Severe infection within 4 weeks prior to the initiation of study treatment.
7. Active tuberculosis infection within 1 year prior to enrollment, identified by medical history or imaging examination.
8. History of immunodeficiency.
9. Active, known, or suspected autoimmune disease, or a history of autoimmune disease.
10. Prior treatment with immune checkpoint inhibitors (ICIs).
11. Undergone major organ surgery within 4 weeks prior to the first dose of the study drug.
12. Any other factors that, in the judgment of the investigator, may affect the study results or force premature termination of the study.