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
Study Type
OBSERVATIONAL
Enrollment
440
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
Hospital General de Segovia
Segovia, Spain
RECRUITINGTime 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
Real-world Pathological Complete Response (rwpCR) in Cohort 1
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.
Time frame: From date of first tislelizumab administration up to 30 months
Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4
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
Time frame: From date of first tislelizumab administration up to 30 months
Real-world Overall Survival (rwOS)
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.
Time frame: At selected landmark timepoints 12-month and 18-month
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Real-world Pathological Complete Response (rwPCR) by Programmed Death Ligand 1 (PD-L1) Level in Cohort 1
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
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
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
Time frame: From date of first tislelizumab administration up to 30 months
Real-world Overall Survival (rwOS) by PD-L1 Level
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
Time frame: From date of first tislelizumab administration up to 30 months