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)

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Non-Small Cell Lung Cancer; Extensive-Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab

• Study Type: Observational
• Enrollment (Estimated): 440

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1-877-828-5568; Email: clinicaltrials@beonemed.com

Study Locations

• Spain
  • Segovia, Spain
    • Recruiting
    • Hospital General de Segovia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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	Drug: 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	Drug: 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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
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	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	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

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 17, 2030

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; tislelizumab
• Other Study ID Numbers: BGB-A317-MA-EU-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No