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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) (TITANS)

11 juin 2026 mis à jour par: BeOne Medicines

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

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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

440

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Espagne
      • Segovia, Espagne
        • Recrutement
        • Hospital General de Segovia

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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
Médicament: 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
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
Médicament: 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
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
Médicament: 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
Cohort 4: Extensive-Stage-SCLC
First-line treatment of adult patients with ES-SCLC
Médicament: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Time from Diagnosis to First Dose
Délai: From date of first tislelizumab administration up to 30 months
From date of first tislelizumab administration up to 30 months
Duration of Treatment
Délai: From date of first tislelizumab administration up to 30 months
From date of first tislelizumab administration up to 30 months
Number of Participants with Dose Modifications
Délai: From date of first tislelizumab administration up to 30 months
From date of first tislelizumab administration up to 30 months
Number of Participants with Treatment Discontinuation
Délai: From date of first tislelizumab administration up to 30 months
From date of first tislelizumab administration up to 30 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Real-world Pathological Complete Response (rwpCR) in Cohort 1
Délai: 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.
From date of first tislelizumab administration up to 30 months
Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4
Délai: 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
From date of first tislelizumab administration up to 30 months
Real-world Overall Survival (rwOS)
Délai: 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.
At selected landmark timepoints 12-month and 18-month
Real-world Pathological Complete Response (rwpCR) by Programmed Death Ligand 1 (PD-L1) Level
Délai: From date of first tislelizumab administration up to 30 months
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
Délai: From date of first tislelizumab administration up to 30 months
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
Délai: From date of first tislelizumab administration up to 30 months
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
From date of first tislelizumab administration up to 30 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

BeOne Medicines

Les enquêteurs

  • Directeur d'études: Study Director, BeOne Medicines

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 juin 2026

Achèvement primaire (Estimé)

15 novembre 2027

Achèvement de l'étude (Estimé)

17 novembre 2030

Dates d'inscription aux études

Première soumission

4 juin 2026

Première soumission répondant aux critères de contrôle qualité

11 juin 2026

Première publication (Réel)

17 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BGB-A317-MA-EU-401

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

See plan description

Critères d'accès au partage IPD

See plan description

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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