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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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 |
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| Cohort 4: Extensive-Stage-SCLC | First-line treatment of adult patients with ES-SCLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of first tislelizumab administration up to 30 months |
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Inclusion Criteria:
Participants are eligible to be included in the study only if they meet all the following criteria:
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:
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Participants with Resectable or Advanced Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer in Europe receiving Tislelizumab in routine clinical practice
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 1-877-828-5568 | clinicaltrials@beonemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Segovia | Recruiting | Segovia | Spain |
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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| 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 | 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. | 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 | The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics | 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 | 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 | From date of first tislelizumab administration up to 30 months |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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