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NCT Number: NCT07652736

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)

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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Key information

Conditions

Advanced Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Extensive-stage Small Cell Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Segovia

Segovia, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants are eligible to be included in the study only if they meet all the following criteria:
  • Participants or their legal representative must sign written inform consent form (ICF)
  • 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:
  • Participants who are unable to understand all implications of study participation.
  • Participants who have contraindications for treatment with tislelizumab in the investigator's opinion or have any contraindication as listed in the SmPC of tislelizumab.
  • Participants who are deemed ineligible according to the investigator's opinion and the SmPC of tislelizumab.

Treatment and study plan

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

Primary outcomes

  1. Time from Diagnosis to First Dose

    Time frame: From date of first tislelizumab administration up to 30 months

  2. Duration of Treatment

    Time frame: From date of first tislelizumab administration up to 30 months

  3. Number of Participants with Dose Modifications

    Time frame: From date of first tislelizumab administration up to 30 months

  4. Number of Participants with Treatment Discontinuation

    Time frame: From date of first tislelizumab administration up to 30 months

Secondary outcomes

  1. Real-world Pathological Complete Response (rwpCR) in Cohort 1

    Time frame: 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.

  2. Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4

    Time frame: 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

  3. Real-world Overall Survival (rwOS)

    Time frame: 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.

  4. Real-world Pathological Complete Response (rwPCR) by Programmed Death Ligand 1 (PD-L1) Level in Cohort 1

    Time frame: From date of first tislelizumab administration up to 30 months

    The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics

  5. Real-world Objective Response Rate (rwORR) by PD-L1 Level in Cohorts 2, 3 and 4

    Time frame: From date of first tislelizumab administration up to 30 months

    The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics

  6. Real-world Overall Survival (rwOS) by PD-L1 Level

    Time frame: From date of first tislelizumab administration up to 30 months

    The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

1-877-828-5568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

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

Acronym: TITANS

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Jun 17, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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