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

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.

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Disease Attributes Disease Progression Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-Small-Cell Lung Cancer Stage IV Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

real-world progression-free survival

Time frame: 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.
overall survival (OS)

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

from diagnosis to death

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

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

Acronym: REALM-Post

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: May 8, 2025
Registry last updated: May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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