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

Analysis of Treatment Patterns and Clinical Outcomes After First-Line Treatment With Tislelizumab in Advanced NSCLC: A Real-World Observational Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06962449
Acronym
REALM-Post
Enrollment
500
Registered
2025-05-08
Start date
2024-08-16
Completion date
2026-12-31
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

Shanghai Chest Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

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.

Design outcomes

Primary

MeasureTime frameDescription
real-world progression-free survivalthe 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.
overall survival (OS)From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 monthsfrom diagnosis to death

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026