NCT07609251尚未招募2 期
A Phase II/III Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form (ICF);
- •Survival duration more than 3 months;
- •Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent/sequential chemoradiotherapy;
- •Without AGA: Have experienced disease progression during or after prior treatment with PD-(L)1 inhibitors and chemotherapy.With AGA: Must have received adequate targeted therapy; EGFR-positive patients must have received prior treatment with PD-(L)1/VEGF bispecific antibody and/or TROP-2 ADC;
- •At least one measurable non-brain lesion according to RECIST v1.1;
- •Adequate major organ function.
排除标准
- •Histologically or cytologically confirmed presence of small cell carcinoma components;
- •Prior treatment with docetaxel;
- •Symptomatic central nervous system (CNS) metastases;
- •Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;
- •Imaging findings at screening show tumor invasion into major blood vessels or surrounding vital organs, or the presence of a risk of esophagotracheal or esophagopleural fistula, which the investigator assesses as unsuitable for enrollment;
- •History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy;
- •Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse;
- •Bleeding tendency, high risk of bleeding, or coagulation disorders;
- •Diagnosis of another malignancy;
- •Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose;
- •Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- •History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease;
- •Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody;
- •Pregnant or breastfeeding women;
- •Any other condition that the investigator considers inappropriate for enrollment.
研究者
研究点 (1)
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