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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tislelizumab.
- Who it may be relevant to
- Registry conditions: Advanced Non-Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug 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
Primary outcome measures
- Time from Diagnosis to First Dose [Time frame: From date of first tislelizumab administration up to 30 months]
- Duration of Treatment [Time frame: From date of first tislelizumab administration up to 30 months]
- Number of Participants with Dose Modifications [Time frame: From date of first tislelizumab administration up to 30 months]
- Number of Participants with Treatment Discontinuation [Time frame: From date of first tislelizumab administration up to 30 months]
Secondary outcome measures (6)
- Real-world Pathological Complete Response (rwpCR) in Cohort 1 [Time frame: From date of first tislelizumab administration up to 30 months]
- Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4 [Time frame: From date of first tislelizumab administration up to 30 months]
- Real-world Overall Survival (rwOS) [Time frame: 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 [Time frame: 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 [Time frame: From date of first tislelizumab administration up to 30 months]
- Real-world Overall Survival (rwOS) by PD-L1 Level [Time frame: From date of first tislelizumab administration up to 30 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital General de Segovia — Segovia
Identifiers
NCT: NCT07652736 · BGB-A317-MA-EU-401