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)
22 juni 2026 uppdaterad av: 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
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
440
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Study Director
- Telefonnummer: 1-877-828-5568
- E-post: clinicaltrials@beonemed.com
Studieorter
-
-
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Segovia, Spanien
- Rekrytering
- Hospital General de Segovia
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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
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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
|
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
|
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
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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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Time from Diagnosis to First Dose
Tidsram: From date of first tislelizumab administration up to 30 months
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From date of first tislelizumab administration up to 30 months
|
|
Duration of Treatment
Tidsram: 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
Tidsram: 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
Tidsram: From date of first tislelizumab administration up to 30 months
|
From date of first tislelizumab administration up to 30 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Real-world Pathological Complete Response (rwpCR) in Cohort 1
Tidsram: 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.
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From date of first tislelizumab administration up to 30 months
|
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Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4
Tidsram: 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)
Tidsram: 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.
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At selected landmark timepoints 12-month and 18-month
|
|
Real-world Overall Survival (rwOS) by PD-L1 Level
Tidsram: 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 Pathological Complete Response (rwPCR) by Programmed Death Ligand 1 (PD-L1) Level in Cohort 1
Tidsram: 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 in Cohorts 2, 3 and 4
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Study Director, BeOne Medicines
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 juni 2026
Primärt slutförande (Beräknad)
15 november 2027
Avslutad studie (Beräknad)
17 november 2030
Studieregistreringsdatum
Först inskickad
4 juni 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BGB-A317-MA-EU-401
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
See plan description
Kriterier för IPD Sharing Access
See plan description
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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