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
| Registry | NCT07652736, acronym TITANS |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 440 (Estimated) |
| Sponsor | BeOne Medicines (Industry) |
| Conditions | Advanced Non-Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer |
| Interventions | Tislelizumab (Drug) |
| Dates | start 2026-06-05, primary completion 2027-11-15 (estimated), completion 2030-11-17 (estimated), first posted 2026-06-17, last updated 2026-10-15 |
| Locations | 6 sites in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Advanced Non-Small Cell Lung Cancer All trials for Extensive-Stage Small Cell Lung Cancer All trials of Tislelizumab
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1: Resectable NSCLC at High Risk of Recurrence | Drug: Tislelizumab | 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% | Drug: Tislelizumab | 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 | Drug: Tislelizumab | 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 | |
| Cohort 4: Extensive-Stage-SCLC | Drug: Tislelizumab | First-line treatment of adult patients with ES-SCLC |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Universitario Reina Sofía | Córdoba | Spain | Recruiting |
| Hospital Universitario de Jaén | Jaén | Spain | Recruiting |
| Hospital Universitario Lucus Augusti (HULA) | Lugo | Spain | Recruiting |
| Hospital de Segovia | Segovia | Spain | Recruiting |
| Hospital General de Segovia | Segovia | Spain | Recruiting |
| Hospital de Sagunto | Valencia | Spain | Recruiting |