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

• 1 other identifier: BGB-A317-MA-EU-401
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Extensive-Stage Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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 (6)

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

  From date of first tislelizumab administration up to 30 months

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

  From date of first tislelizumab administration up to 30 months

• Real-world Overall Survival (rwOS)

  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

  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

  From date of first tislelizumab administration up to 30 months

Study Arms (4)

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

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

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

Cohort 4: Extensive-Stage-SCLC

First-line treatment of adult patients with ES-SCLC

Drug: Tislelizumab

Interventions

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

Cohort 1: Resectable NSCLC at High Risk of Recurrence; Cohort 2: Non-squamous NSCLC and Programmed Death Ligand 1 (PD-L1) ≥ 50%; Cohort 3: Locally Advanced or Metastatic Squamous NSCLC; Cohort 4: Extensive-Stage-SCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (1)

Hospital General de Segovia

Segovia, Spain

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1-877-828-5568; clinicaltrials@beonemed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 17, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 17, 2030
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

ES (1)