Real-World Assessment of Therapeutic Strategies and Survival Outcomes Following First-Line Tislelizumab Therapy in Advanced Non-Small Cell Lung Cancer

• Conditions: Non-Small-Cell Lung Cancer; Non-Small-Cell Lung Cancer Stage IV

• Registration Number: NCT06962449
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This study is an observational study evaluating the treatment patterns and clinical outcomes after progression on first-line Tislelizumab treatment in advanced NSCLC. Based on the inclusion and exclusion criteria, patients with advanced NSCLC who received first-line Tislelizumab treatment and progressed will be retrospectively screened and collected from January 1, 2020, to the study initiation date, and followed up for observation.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-16
• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC based on the 8th edition of the AJCC staging system.
• Previously received first-line treatment with Tislelizumab for advanced NSCLC.
• Medical records of disease progression after first-line treatment.

Exclusion Criteria

• Patients with incomplete key baseline and treatment information，including clinical stage, pathological type, treatment regimen, tumor assessment record after treatment ect.
• Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months	from diagnosis to death
real-world progression-free survival	the time from the start of treatment to the first recorded progression event in the medical information system or death from any cause, whichever occurs first, excluding events within 14 days after the start of treament.	rwPFS is defined as the time from the start of treatment to the first recorded progression event (imaging report or clinician judgment) in the medical information system or death from any cause, whichever occurs first, excluding events within 14 days after the start of treatment.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China