本临床试验旨在评估 dostarlimab 联合 belrestotug 相比 pembrolizumab 联合安慰剂在既往未经治疗、不可切除的局部晚期或转移性 PD-L1 高表达 NSCLC 参与者中的安全性及耐受性特征。
适应症：Lung Cancer, Non-Small Cell
入组条件
纳入标准
- Has a histologically or cytologically confirmed diagnosis of locally advanced, unresectable NSCLC (not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy), or Metastatic NSCLC
- Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.
- Provides a fresh tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC.
- Has a PD-L1-high (Tumor cells \[TC\] ≥50%) tumor
- Has measurable disease (at least 1 target lesion) based on RECIST 1.1
- Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0 or 1.
- Has adequate organ function
排除标准
- Has NSCLC with a tumor that harbors any of the following molecular alterations:
- Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy
- Anaplastic lymphoma kinase (ALK) translocations that are sensitive to available targeted inhibitor therapy
- Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first line treatment of locally advanced or metastatic NSCLC.
- Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events ≥ Grade 1)/complications related to surgery or has received lung radiation therapy of \>30 gray (Gy) within 6 months
- Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpoint pathways.
- Has never smoked, defined as smoking \<100 tobacco cigarettes in a lifetime.
- Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome.
- Has symptomatic, untreated, or actively progressin g brain metastases or leptomeningeal disease
- Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
- Has received any live vaccine within 30 days prior to first dose of study intervention.
- Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.
- Has symptomatic ascites, pleural effusion, or pericardial effusion.
- Has active inflammatory bowel disease
- Has a history of significant acute or chronic cardiac diagnosis requiring intervention/treatment in the last 6 months.
- Has severe infection or complication thereof 4 weeks prior to randomisation including active tuberculosis.
- Has a history of allogeneic tissue/stem cell transplant or solid organ transplant.
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。