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)

NCT07652736 — Recruiting, 440 participants, BeOne Medicines

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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

RegistryNCT07652736, acronym TITANS
StatusRecruiting
Study typeObservational
Enrollment440 (Estimated)
SponsorBeOne Medicines (Industry)
ConditionsAdvanced Non-Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
InterventionsTislelizumab (Drug)
Datesstart 2026-06-05, primary completion 2027-11-15 (estimated), completion 2030-11-17 (estimated), first posted 2026-06-17, last updated 2026-10-15
Locations6 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

-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

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+Arms and interventions

ArmTypeInterventionsDescription
Cohort 1: Resectable NSCLC at High Risk of RecurrenceDrug: TislelizumabNeoadjuvant 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: TislelizumabFirst-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 NSCLCDrug: TislelizumabFirst-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-SCLCDrug: TislelizumabFirst-line treatment of adult patients with ES-SCLC
  • 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

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

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.

+Locations (6)

FacilityCityCountryStatus
Hospital Universitario Reina SofíaCórdobaSpainRecruiting
Hospital Universitario de JaénJaénSpainRecruiting
Hospital Universitario Lucus Augusti (HULA)LugoSpainRecruiting
Hospital de SegoviaSegoviaSpainRecruiting
Hospital General de SegoviaSegoviaSpainRecruiting
Hospital de SaguntoValenciaSpainRecruiting

+Investigators

  • Study Director, Study director, BeOne Medicines