NCT05387512

Real-world Association Between Concomitant Beta-blocker Exposure and Anti-PD-1/PD-L1 Treatment Outcomes in Advanced Non-Small Cell Lung Cancer

A Retrospective Observational Cohort Study Evaluating the Association Between Concomitant Beta-blocker Exposure and Clinical Outcomes of Standard Anti-PD-1/PD-L1 Therapy in Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This retrospective real-world cohort study evaluated whether concomitant long-term beta-blocker exposure during routine clinical care was associated with clinical outcomes in patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy. Patients were categorized according to documented concomitant long-term beta-blocker exposure during the treatment course. Clinical outcomes, including progression-free survival, objective response rate, and overall survival, were compared between exposure groups. This was a non-interventional observational study; anti-PD-1/PD-L1 treatment and beta-blocker use were determined by routine clinical practice rather than by the study protocol.

Detailed description

Background: Emerging evidence suggests that beta-adrenergic signaling may contribute to T-cell dysfunction and resistance to immune checkpoint blockade. This retrospective real-world cohort study was designed to investigate whether concomitant long-term beta-blocker exposure during routine clinical care was associated with treatment outcomes in patients with advanced NSCLC receiving standard anti-PD-1/PD-L1 inhibitor therapy. Study Design: Clinical data and follow-up information were collected retrospectively from eligible patients treated in routine clinical practice at the Affiliated Hospital of Nantong University during the predefined study period. Patients were categorized into exposure cohorts according to whether they had documented concomitant long-term beta-blocker use during anti-PD-1/PD-L1 treatment. The study did not assign treatment or medication exposure; all therapies and concomitant medications were prescribed according to standard clinical indications and physician judgment. Objectives: The primary objective was to assess the association between concomitant long-term beta-blocker exposure and progression-free survival. Secondary objectives included evaluation of objective response rate and overall survival. The study was intended to provide real-world observational evidence regarding the clinical relevance of beta-blocker exposure in the setting of standard anti-PD-1/PD-L1 therapy for advanced NSCLC.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anti-PD-1/PD-L1 Therapy (Standard of Care)	Standard anti-PD-1/PD-L1 inhibitor therapy administered as part of routine clinical care. Treatment regimen, schedule, and duration were determined by treating physicians according to standard practice and were not assigned by the study.
DRUG	Beta-blocker (Concomitant Exposure)	Documented concomitant long-term beta-blocker use during the anti-PD-1/PD-L1 treatment course as prescribed for routine clinical indications. Beta-blocker exposure was not assigned by the study protocol.

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2022-05-24
• Last updated: 2026-04-06

Locations

1 site across 1 country: China