A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) (TITANS)
2026年6月22日 更新者：BeOne Medicines
A Real-World Evaluation of Tislelizumab Treatment Patterns and Effectiveness in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer and Small Cell Lung Cancer
The purpose of this study is to collect real-world data on treatment patterns and clinical outcomes in European patients receiving tislelizumab in routine clinical practice
研究概览
研究类型
观察性的
注册 (估计的)
440
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Study Director
- 电话号码：1-877-828-5568
- 邮箱：clinicaltrials@beonemed.com
学习地点
-
-
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Segovia、西班牙
- 招聘中
- Hospital General de Segovia
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Participants with Resectable or Advanced Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer in Europe receiving Tislelizumab in routine clinical practice
描述
Inclusion Criteria:
Participants are eligible to be included in the study only if they meet all the following criteria:
- Participants or their legal representative must sign written inform consent form (ICF)
- Participants receive tislelizumab as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the SmPC, within the approved indications in the 4 cohorts described.
Note: The decision to treat the patient with a tislelizumab-based regimen, as per its authorized indication, must have been made by the treating physician prior to and independent of the patient's consideration for participation in this study.
Exclusion Criteria:
Participants are excluded from the study if they meet any of the following criteria:
- Participants who are unable to understand all implications of study participation.
- Participants who have contraindications for treatment with tislelizumab in the investigator's opinion or have any contraindication as listed in the SmPC of tislelizumab.
- Participants who are deemed ineligible according to the investigator's opinion and the SmPC of tislelizumab.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Cohort 1: Resectable NSCLC at High Risk of Recurrence
Neoadjuvant treatment and then adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence
|
Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care
|
|
Cohort 2: Non-squamous NSCLC and Programmed Death Ligand 1 (PD-L1) ≥ 50%
First-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC
|
Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care
|
|
Cohort 3: Locally Advanced or Metastatic Squamous NSCLC
First-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC
|
Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care
|
|
Cohort 4: Extensive-Stage-SCLC
First-line treatment of adult patients with ES-SCLC
|
Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Time from Diagnosis to First Dose
大体时间：From date of first tislelizumab administration up to 30 months
|
From date of first tislelizumab administration up to 30 months
|
|
Duration of Treatment
大体时间：From date of first tislelizumab administration up to 30 months
|
From date of first tislelizumab administration up to 30 months
|
|
Number of Participants with Dose Modifications
大体时间：From date of first tislelizumab administration up to 30 months
|
From date of first tislelizumab administration up to 30 months
|
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Number of Participants with Treatment Discontinuation
大体时间：From date of first tislelizumab administration up to 30 months
|
From date of first tislelizumab administration up to 30 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Real-world Pathological Complete Response (rwpCR) in Cohort 1
大体时间：From date of first tislelizumab administration up to 30 months
|
The rwpCR is defined as the percentage of participants with resectable NSCLC who, according to available local surgical pathology reports as per routine clinical practice, demonstrate no residual viable tumor cells in the resected primary tumor and lymph nodes after neoadjuvant tislelizumab treatment.
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From date of first tislelizumab administration up to 30 months
|
|
Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4
大体时间：From date of first tislelizumab administration up to 30 months
|
The rwORR is defined as the percentage of participants with non-squamous NSCLC, squamous NSCLC, ES-SCLC, respectively, achieving a best overall response of complete or partial response (CR) or (PR) to tislelizumab, as assessed by the treating physician based on routine clinical documentation
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From date of first tislelizumab administration up to 30 months
|
|
Real-world Overall Survival (rwOS)
大体时间：At selected landmark timepoints 12-month and 18-month
|
The rwOS is defined as the time from the date of first dose of study treatment to the date of death due to any cause.
|
At selected landmark timepoints 12-month and 18-month
|
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Real-world Overall Survival (rwOS) by PD-L1 Level
大体时间：From date of first tislelizumab administration up to 30 months
|
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
|
From date of first tislelizumab administration up to 30 months
|
|
Real-world Pathological Complete Response (rwPCR) by Programmed Death Ligand 1 (PD-L1) Level in Cohort 1
大体时间：From date of first tislelizumab administration up to 30 months
|
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
|
From date of first tislelizumab administration up to 30 months
|
|
Real-world Objective Response Rate (rwORR) by PD-L1 Level in Cohorts 2, 3 and 4
大体时间：From date of first tislelizumab administration up to 30 months
|
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
|
From date of first tislelizumab administration up to 30 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Study Director、BeOne Medicines
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月5日
初级完成 (估计的)
2027年11月15日
研究完成 (估计的)
2030年11月17日
研究注册日期
首次提交
2026年6月4日
首先提交符合 QC 标准的
2026年6月11日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- BGB-A317-MA-EU-401
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
IPD 共享时间框架
See plan description
IPD 共享访问标准
See plan description
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.