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

NCT06962449 | Enrolling By Invitation

• 1 other identifier: IS24123
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Cancer; Non-Small-Cell Lung Cancer Stage IV

Keywords

advanced non-small-cell Lung cancer; real-world study; Tislelizumab; progression

Outcome Measures

Primary Outcomes (2)

• real-world progression-free survival

  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.

  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.

• overall survival (OS)

  from diagnosis to death

  From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced NSCLC who progressed after first-line treatment with Tislelizumab

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Disease Progression

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: August 16, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-04

Locations

CN (1)