Advanced Non-Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
Conditions
Brief summary
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
DRUGTislelizumab
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
Sponsors
BeOne Medicines
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants are eligible to be included in the study only if they meet all the following criteria: 1. Participants or their legal representative must sign written inform consent form (ICF) 2. 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: 1. Participants who are unable to understand all implications of study participation. 2. Participants who have contraindications for treatment with tislelizumab in the investigator's opinion or have any contraindication as listed in the SmPC of tislelizumab. 3. Participants who are deemed ineligible according to the investigator's opinion and the SmPC of tislelizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from Diagnosis to First Dose | From date of first tislelizumab administration up to 30 months |
| Duration of Treatment | From date of first tislelizumab administration up to 30 months |
| Number of Participants with Dose Modifications | From date of first tislelizumab administration up to 30 months |
| Number of Participants with Treatment Discontinuation | From date of first tislelizumab administration up to 30 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Pathological Complete Response (rwpCR) in Cohort 1 | 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. |
| Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4 | 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 |
| Real-world Overall Survival (rwOS) | 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. |
| Real-world Pathological Complete Response (rwPCR) by Programmed Death Ligand 1 (PD-L1) Level in Cohort 1 | From date of first tislelizumab administration up to 30 months | The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics |
| Real-world Objective Response Rate (rwORR) by PD-L1 Level in Cohorts 2, 3 and 4 | From date of first tislelizumab administration up to 30 months | The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics |
| Real-world Overall Survival (rwOS) by PD-L1 Level | From date of first tislelizumab administration up to 30 months | The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics |
Countries
Spain
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed