Advanced Non-Small Cell Lung CancerTITANSNCT07652736
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)
An observational study of Advanced Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer, run by BeOne Medicines at 6 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- Tislelizumab
- How many people
- 440 participants
- Where
- 6 sitesSpain
- Study dates
- 5 Jun 2026to 17 Nov 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario Reina Sofía
Córdoba
- Recruiting
Hospital Universitario de Jaén
Jaén
- Recruiting
Hospital Universitario Lucus Augusti (HULA)
Lugo
- Recruiting
Hospital de Segovia
Segovia
- Recruiting
Hospital General de Segovia
Segovia
- Recruiting
Hospital de Sagunto
Valencia
About this study
Official 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
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
- Being tested
- Tislelizumab
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tislelizumab | |
| 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 Receives: Drug: Tislelizumab | |
| 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 Receives: Drug: Tislelizumab | |
| Cohort 4: Extensive-Stage-SCLC | First-line treatment of adult patients with ES-SCLC Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from Diagnosis to First Dose
Measured: From date of first tislelizumab administration up to 30 months
Duration of Treatment
Measured: From date of first tislelizumab administration up to 30 months
Number of Participants with Dose Modifications
Measured: From date of first tislelizumab administration up to 30 months
Number of Participants with Treatment Discontinuation
Measured: From date of first tislelizumab administration up to 30 months
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: At selected landmark timepoints 12-month and 18-month
Real-world Pathological Complete Response (rwPCR) by Programmed Death Ligand 1 (PD-L1) Level in Cohort 1
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
Measured: From date of first tislelizumab administration up to 30 months
Real-world Objective Response Rate (rwORR) by PD-L1 Level in Cohorts 2, 3 and 4
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
Measured: 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
Measured: From date of first tislelizumab administration up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start5 Jun 2026
- Primary completion15 Nov 2027 (estimated)
- Study completion17 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652736
- Sponsor's protocol ID
- BGB-A317-MA-EU-401
- Acronym
- TITANS
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.