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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 1
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Tislelizumab (Drug)
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
干预措施: Tislelizumab (Drug)
Cohort 4: Extensive-Stage-SCLC
First-line treatment of adult patients with ES-SCLC
干预措施: Tislelizumab (Drug)
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
干预措施: Tislelizumab (Drug)