本臨床研究旨在進一步了解研究藥物 sacituzumab govitecan-hziy(SG)及其與 pembrolizumab 或 pembrolizumab 加鉑類藥物(carboplatin 或 cisplatin)聯合使用的劑量,用於晚期或轉移性(已擴散)非小細胞肺癌(NSCLC)患者。
適應症:Non-small Cell Lung Cancer
收案條件
納入條件
- Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator
- No prior systemic treatment for metastatic NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate hematologic counts
- Adequate hepatic function
排除條件
- Mixed SCLC and NSCLC histology
- Active second malignancy
- NSCLC that is eligible for definitive local therapy alone
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has had an allogenic tissue/solid organ transplant.
- Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient
- Has received radiation therapy to the lung
- Individuals may not have received systemic anticancer treatment within the previous 6 months
- Is currently participating in or has participated in a study of an investigational agent
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Known active central nervous system (CNS) metastases
- History of cardiac disease
- Active chronic inflammatory bowel disease
- Active serious infection requiring antibiotics
- Active or chronic hepatitis B infection
- Positive hepatitis C antibody
- Positive serum pregnancy test or women who are lactating
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。