NCT05207904Unknown2 期
A Phase II, Prospective Clinical Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Brain Metastases of Squamous Non-small Cell Lung Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年6月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- intracranial progression-free survival (iPFS) after treatment with tislelizumab plus chemotherapy in patients with asymptomatic brain metastases or stable symptoms after stereotactic radiotherapy (according to RECIST 1.1)
研究概览
简要总结
This study is a prospective, single-arm, phase II clinical study to evaluate the efficacy and safety of Tislelizumab Plus Chemotherapy in patients with squamous NSCLC with brain metastases who had not previously received systemic therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed squamous non-small cell lung cancer;
- •Asymptomatic brain metastases or brain metastases that are relieved by dehydration therapy and remain clinically stable for at least 2 weeks
- •MRI confirmed tumor parenchymal metastases, ≥ 3 brain lesions; or patients with 1-2 brain lesions but do not require local treatment or refuse local treatment. At least one measurable lesion in the brain lesion must be ≥ 5mm in diameter; patients with local meningeal metastasis are allowed, but those with extensive meningeal metastasis are not included
- •Patients with stable brain metastasis symptoms after stereotactic radiotherapy are allowed (the number of stereotactic radiotherapy lesions is not more than 3)
- •No prior systemic treatment for metastatic NSCLC
- •Tumor tissue biomarker detection results must meet the following conditions at the same time: （1）EGFR mutation negative.（2）ALK rearrangement negative.（3）There are sufficient tissue samples for PD-L1 detection
- •Aged ≥ 18 years and ≤ 75 years
- •ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1
- •Life expectancy of more than 3 months
- •Have adequate organ function as indicated by the following laboratory values
- •Written informed consent before any trial-related procedures are performed
排除标准
- •Subjects with any of the following criteria may not be included in this study:
- •With mixed adenosquamous carcinoma or small cell lung cancer mainly composed of adenocarcinoma
- •Currently participating in interventional clinical study treatment, or have received other investigational drugs or investigational device treatment before the first dose;
- •Received prior therapies targeting PD-1, PD-L1, CTLA-4, cytotoxic chemotherapy or other immune checkpoints inhibitors
- •Received solid organ or blood system transplantation
- •Have active autoimmune diseases requiring systemic therapy within 2 years before the first dose
- •Diagnosis of immunodeficiency or systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study
- •History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year before the first dose
- •Known history of human immunodeficiency virus (HIV) infection
- •Untreated active hepatitis B; Note: hepatitis B subjects who meet the following criteria are also eligible: a) HBV viral load must be < 1000 copies/ml before the first dose, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study chemotherapy drug treatment b) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored;
- •Subjects with active HCV infection
- •Pregnant and lactating women
- •Malignant tumors other than NSCLC within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell epithelial skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection
研究组 & 干预措施
tislelizumab plus chemotherapy
Experimental
干预措施: Tislelizumab, paclitaxel, Carboplatin (Drug)
结局指标
主要结局
intracranial progression-free survival (iPFS) after treatment with tislelizumab plus chemotherapy in patients with asymptomatic brain metastases or stable symptoms after stereotactic radiotherapy (according to RECIST 1.1)
时间窗: 12months
Intracranial Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of intracranial disease progression or death, whichever occurs first
次要结局
- progression-free survival (PFS) (according to RECIST 1.1)(12months)
- overall survival (OS) (according to RECIST 1.1)(24months)
- Safety of treatment was assessed using NCI-CTCAEv5 version(24months)
- Assessment of neurocognitive deterioration(24months)
- intracranial objective response rate (iORR) (according to RECIST 1.1)(12months)
- objective response rate (ORR) (according to RECIST 1.1)(12months)
研究者
Li-kun Chen
sun yat-sen university cancer center
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal CancerLocally Advanced Rectal CancerNCT06760520The First Affiliated Hospital of Zhengzhou University40
尚未招募
2 期
Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive CarcinomaPD-1 AntibodyDC-CellNK-CellGastrointestinal TumoursNCT05461235China Medical University, China1
尚未招募
2 期
Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma (HNSCC)NCT06714266Shandong Cancer Hospital and Institute30
Unknown
2 期
A Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell CarcinomaOral Squamous Cell CarcinomaNCT04367909Xin-Hua Xu68
Unknown
2 期
A Study of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy.Nonsquamous Non-Small Cell Lung CancerNCT03863483Xin-Hua Xu70