这是一项第三期、随机、双盲、安慰剂对照、多中心研究,评估 durvalumab 对比安慰剂作为巩固治疗,用于局部晚期、不可切除的非小细胞肺癌(第三期)患者,这些患者在接受确定性铂类化放疗后未出现疾病进展。
适应症:Carcinoma, Non-Small-Cell Lung
入组条件
纳入标准
- Age≥18 years
- Documented NSCLC and present with locally advanced, unresectable (Stage III) disease;
- Receipt of concurrent or sequential chemoradiation therapy,
- No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy
- World Health Organization (WHO) PS of 0 or 1;
- No prior exposure to any anti CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, excluding therapeutic anticancer vaccines
- Adequate organ and marrow function required
- Life expectancy of at least 12 weeks
- Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory, must be known prior to randomization.
- Tumour sample requirements are as follows: Provision of a tumour tissue sample (newly acquired sample \<=3 months old is preferred, but an archived sample \<=6 months old is acceptable) in a quantity sufficient to allow for analysis.
排除标准
- History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency.
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent
- Active infection including tuberculosis hepatitis B hepatitis C (HCV), or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies).
- Mixed small cell and NSCLC histology, sarcomatoid variant
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation therapy.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。