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NCT Number: NCT05387512

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pharmacy, Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older;
  • Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer;
  • Received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care;
  • Available baseline clinical records and follow-up data sufficient for assessment of treatment exposure and clinical outcomes;

Exclusion criteria

  • Incomplete baseline clinical records or follow-up data that preclude assessment of treatment exposure or clinical outcomes;
  • Concomitant participation in an interventional therapeutic clinical trial affecting the same treatment course, if applicable;
  • Other major clinical conditions or competing malignancies that preclude valid outcome assessment, according to the prespecified study protocol

Treatment and study plan

Anti-PD-1/PD-L1 Therapy (Standard of Care)

Drug

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.

Beta-blocker (Concomitant Exposure)

Drug

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.

Primary outcomes

  1. Progression-Free Survival

    Time frame: From initiation of anti-PD-1/PD-L1 therapy to first documented disease progression or death from any cause, assessed up to 36 months

    Progression-free survival is defined as the time from initiation of anti-PD-1/PD-L1 therapy to the first documented disease progression or death from any cause, whichever occurs first.

Secondary outcomes

  1. Objective Response Rate

    Time frame: Best overall response during the first 12 months after initiation of anti-PD-1/PD-L1 therapy

    Objective response rate is defined as the proportion of patients achieving complete response or partial response according to RECIST version 1.1 based on available radiologic assessments in routine clinical care.

  2. Overall Survival

    Time frame: From initiation of anti-PD-1/PD-L1 therapy to death from any cause, assessed up to 36 months

    Overall survival is defined as the time from initiation of anti-PD-1/PD-L1 therapy to death from any cause.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Collaborators

  • The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 24, 2022
Registry last updated
Apr 6, 2026

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.

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