NCT05758116已完成2 期
A Prospective, Open-label, Single-arm, Phase II Trial Investigating the Efficacy and Safety of Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2022年7月7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
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. These patients are more likely to develop distant metastases and therefore may require tolerable systemic consolidation regimens. However, there is a lack of evidence from clinical studies on consolidation immunotherapy after radiotherapy alone or sequential chemoradiation. The aim of the study is to explore the efficacy and safety of Tislelizumab consolidation therapy after radiotherapy or sequential chemoradiation in locally advanced NSCLC patients who are intolerable of concurrent concurrent chemoradiation.
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
- •Patients with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery;
- •Intolerable of concurrent chemoradiation;
- •No progression after radiotherapy or sequential chemoradiation;
- •Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50Gy to 66Gy;
- •ECOG PS0-2;
- •Age≥18 years, and life expectancy>3 months;
- •Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose);
- •Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule.
排除标准
- •Patients with EGFR-sensitive mutations and ALK rearrangements;
- •Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway);
- •History of allergy to components of Tislelizumab;
- •Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ);
- •History of interstitial lung disease or pneumonia requiring oral or intravenous steroids;
- •Progression after radiotherapy or sequential chemoradiation;
- •Unresolved ≥grade2 toxicities from radiotherapy and sequential chemoradiation, (excluding those that the investigator determines do not affect study treatment, such as alopecia);
- •Grade 2 or severe Pneumonia from radiotherapy or sequential chemoradiation;
- •Administration of a live vaccine within 30 days prior to treatment start (seasonal influenza vaccine without live vaccine is allowed);
- •Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibacterial, antifungal or antiviral therapy ≤ 14 days prior to treatment start;
- •History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
- •History of active autoimmune disease requiring systemic therapy;
- •Treatment with long-term systemic immunosuppressive medications (≥10 mg/d prednisone or equivalent doses of other steroids) or other immunosuppressive medications;
- •History of uncontrolled cardiovascular disease; or clinically significant QT interval prolongation, or QTc interval >480 ms during screening period;
- •Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; ALT/AST > 2.5 times of the upper limit of normal value in patients without liver metastases and ALT/AST > 5 times of the upper limit of normal value in patients with liver metastases], abnormal renal function (serum creatinine > 1.5 times of the upper limit of normal value);
- •History of serious concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) ;
- •History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia;
- •Unsuitable for participation in this study assessed by investigators;
- •Patients who were already enrolled in other clinical studies;
- •Mixed lung cancer with small cell components.
研究组 & 干预措施
Consolidation Tislelizumab
Experimental
Patients completed radiotherapy alone or sequential chemoradiation with 42 days received consolidation Tislelizumab 200mg every 3 weeks for 12 months.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 6 months after enrollment
Defined from the date of enrollment to the date of death or any recurrence.
次要结局
- Treatment-related adverse events(Duration of treatment and follow up until death or 3 years after enrollment)
- Overall survival(From date of enrollment to maximum of 3 years or death)
- Objective response rate(From date of enrollment to maximum of 3 years or death)
研究者
Rong Yu, MD
Professor
Peking University Cancer Hospital & Institute
研究点 (1)
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