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)

Официальное название

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

Обзор

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

Вмешательства

• Препарат Tislelizumab
  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

Первичные конечные точки

• Time from Diagnosis to First Dose [Срок оценки: From date of first tislelizumab administration up to 30 months]
• Duration of Treatment [Срок оценки: From date of first tislelizumab administration up to 30 months]
• Number of Participants with Dose Modifications [Срок оценки: From date of first tislelizumab administration up to 30 months]
• Number of Participants with Treatment Discontinuation [Срок оценки: From date of first tislelizumab administration up to 30 months]

Вторичные конечные точки (6)

• Real-world Pathological Complete Response (rwpCR) in Cohort 1 [Срок оценки: From date of first tislelizumab administration up to 30 months]
• Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4 [Срок оценки: From date of first tislelizumab administration up to 30 months]
• Real-world Overall Survival (rwOS) [Срок оценки: At selected landmark timepoints 12-month and 18-month]
• Real-world Pathological Complete Response (rwPCR) by Programmed Death Ligand 1 (PD-L1) Level in Cohort 1 [Срок оценки: 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 [Срок оценки: From date of first tislelizumab administration up to 30 months]
• Real-world Overall Survival (rwOS) by PD-L1 Level [Срок оценки: From date of first tislelizumab administration up to 30 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Hospital General de Segovia — Segovia

Идентификаторы

NCT: NCT07652736 · BGB-A317-MA-EU-401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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