NCT06749886招募中2 期
An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting
Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年11月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- progress free survival
研究概览
简要总结
The goal of this clinical trial is to explore the efficacy and safety of denosumab in combination with tislelizumab and chemotherapy in the second-line treatment of immuno-experienced patients with EGFR/ALK/ROS1-negative advanced NSCLC.
Primary endpoint:
progression-free survival (PFS) assessed by investigators according to RECIST 1.1;
Secondary endpoint:
- Overall survival (OS) assessed by investigators according to RECIST 1.1;
- Objective response rate (ORR) assessed by investigators according to RECIST 1.1;
- Disease control rate (DCR) assessed by investigators according to RECIST 1.1;
- Duration of response (DOR) assessed by investigators according to RECIST 1.1;
Exploratory endpoint:
bone metastasis-free survival.
Participants will receive denosumab combined with tislelizumab and docetaxel.
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
- •Age≥ 18 years old;
- •Patients with histologically or cytologically confirmed non-bone metastases stage IV NSCLC;
- •EGFR, ALK, and ROS1 are all wild-type (for other driver genes, if there is no first-line approval for corresponding targeted therapy or if the patient refuses targeted therapy, these patients are allowed to be enrolled);
- •first-line treatment with immune checkpoint inhibitors and clinical benefit (PFS ≥ 3 months);
- •Have measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is ≥10mm, the short diameter of CT scan of lymph node lesions is ≥15mm, and the thickness of the scanning layer is not more than 5mm, and the measurable lesions have not received local treatment such as radiotherapy and cryotherapy);
- •ECOG PS: 0-2 points;
- •Estimated survival time≥ 3 months;
- •Adequate hematologic function, defined as absolute neutrophil count ≥1.5×109/L, platelet count ≥ 80×109/L, hemoglobin ≥ 90g/L (no history of blood transfusion within 7 days, not corrected with G-CSF and other hematopoietic stimulating factors);
- •adequate liver function, defined as total bilirubin levels ≤1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or for patients with liver metastases, AST and ALT levels ≤ 5 times ULN;
- •adequate renal function, defined as creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
- •Adequate coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
- •For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug, and if the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required;
- •If there is a risk of conception, male and female patients need to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) and continue until at least 180 days after stopping the trial treatment (Note: abstinence can be accepted as a contraceptive method if abstinence is the subject's usual lifestyle and preferred contraceptive method);
- •Subjects voluntarily joined this study, signed a written informed consent form before the implementation of any trial-related procedures, had good compliance, and cooperated with follow-up.
排除标准
- •Patients on first-line docetaxel chemotherapy;
- •Patients with symptomatic brain metastases (symptoms of brain metastases remain clinically stable for at least 1 month after treatment, and no steroids and anticonvulsants can be enrolled for at least 1 month before entering the study);
- •Presence of clinically uncontrollable pleural effusion/ascites effusion (patients who do not need to drain the effusion or who have stopped draining for 3 days without a significant increase in effusion can be enrolled);
- •have not recovered adequately from toxicity and/or complications caused by any intervention (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);
- •Diagnosis of other malignant tumors within 5 years before the first dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ that has undergone radical resection, if other malignant tumors or lung cancer are diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent metastatic lesions is required;
- •Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction and peritoneal metastasis requiring clinical intervention;
- •Received solid organ or blood system transplantation;
- •Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia;
- •Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy;
- •Patients who need long-term systemic use of corticosteroids (patients who need intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroids due to COPD and asthma can be enrolled);
- •History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year before the first dose;
- •Have an active infection requiring treatment or have used systemic anti-infective drugs within one week before the first dose;
- •Known psychiatric illness or substance abuse that may affect compliance with trial requirements;
- •Those who are considered unsuitable for inclusion by the investigator.
研究组 & 干预措施
cohort1
Experimental
The subjects in this cohort will receive denosumab combined with tislelizumab and docetaxel.
干预措施: Denosumab (Drug)
cohort1
Experimental
The subjects in this cohort will receive denosumab combined with tislelizumab and docetaxel.
干预措施: tislelizumab (Drug)
cohort1
Experimental
The subjects in this cohort will receive denosumab combined with tislelizumab and docetaxel.
干预措施: Docetaxel (Drug)
结局指标
主要结局
progress free survival
时间窗: up to 24 months
Progression-free survival refers to the time from the start of combined treatment to any objectively documented tumor progression or patient death (the last follow-up date for patients lost to follow-up; the end of follow-up date for patients still alive at the end of the study).
次要结局
- overall survival(up to 24 months)
- objective response rate(12 months)
- Disease control rate(12 months)
- Duration of remission(12 months)
研究者
Chunxia Su
Director of the Clinical Research Center
Shanghai Pulmonary Hospital, Shanghai, China
研究点 (1)
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