A Single-Arm, Exploratory Study of Adebrelimab Combined With Etoposide Capsules as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
This prospective clinical study aims to evaluate and observe the efficacy and safety of adebrelimab combined with etoposide capsules in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 32 patients. The study commenced in August 2025, and recruitment is expected to conclude around December 2026, with the trial anticipated to end by December 2027. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.
• Voluntary participation with signed informed consent and good compliance for follow-up.
• Age between 18 and 75 years old.
• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria.
• ECOG performance status score: 0 to 2.
• Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Adebrelimab induction therapy.
• Recovery of non-hematologic adverse reactions to grade 1 (except for alopecia, skin pigment changes, or as determined by the investigator) following induction therapy.
• Time from the end of induction treatment (last dose) to initiation of maintenance treatment ≤ 6 weeks.
• At least one measurable lesion assessed by the investigator according to RECIST 1.1.
• Normal function of major organs, meeting the following criteria:
⁃ (1)Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L (grade 1 according to CTCAE 5.0); platelets ≥ 100×10\^9/L; hemoglobin \> 80g/L.
⁃ (2)Renal function: Creatinine ≤ 1.5 times the upper limit of normal (ULN), grade 1 according to CTCAE. Note: If creatinine is greater than 1.5 times the ULN, creatinine clearance must be \> 50ml/min.
⁃ (3)Liver function: Bilirubin ≤ 1.5 times ULN (grade 1 according to CTCAE), patients with Gilbert's syndrome bilirubin ≤ 3.0 times ULN; AST and ALT ≤ 3.0×ULN.
⁃ (4)Coagulation indicators: International normalized ratio (INR) ≤ 1.55 (if the patient is receiving a stable dose of therapeutic warfarin or low molecular weight heparin, INR is usually between 2 and 3), PTT \< 1.2 times ULN.
• Women of childbearing potential must agree to use contraception during the study and for 6 months after the end of the study (such as an intrauterine device, contraceptive pills, or condoms); serum or urine pregnancy test must be negative within 1 week before enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the end of the study.