Non-Small Cell Lung CancerNCT05387512
Real-world Association Between Concomitant Beta-blocker Exposure and Anti-PD-1/PD-L1 Treatment Outcomes in Advanced Non-Small Cell Lung Cancer
An observational study of Non-Small Cell Lung Cancer, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Beta-blocker (Concomitant Exposure)
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study included eligible patients with advanced non-small cell lung cancer who received standard anti-PD-1/PD-L1 inhibitor therapy in routine clinical practice at the Affiliated Hospital of Nantong University during the predefined study period. Clinical records and follow-up information were collected retrospectively. Patients were categorized into exposure cohorts according to documented concomitant long-term beta-blocker use during the anti-PD-1/PD-L1 treatment course.
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pharmacy, Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
About this study
Official 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
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.
Read the 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
- Being tested
- Anti-PD-1/PD-L1 Therapy (Standard of Care), Beta-blocker (Concomitant Exposure)
- Keywords
- Non-Small Cell Lung Cancer, PD-1, Beta-blocker, NSCLC, PD-L1, Real-world Study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Anti-PD-1/PD-L1 Therapy Without Long-term Beta-blocker Exposure | Patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care and had no documented long-term beta-blocker exposure during the relevant treatment period. Receives: Drug: Anti-PD-1/PD-L1 Therapy (Standard of Care) | |
| Standard Anti-PD-1/PD-L1 Therapy With Concomitant Long-term Beta-blocker Exposure | Patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care and had documented concomitant long-term beta-blocker exposure during the relevant treatment period. Beta-blockers were prescribed for routine clinical indications and were not assigned by the study protocol. Receives: Drug: Anti-PD-1/PD-L1 Therapy (Standard of Care); Drug: Beta-blocker (Concomitant Exposure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
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.
Measured: From initiation of anti-PD-1/PD-L1 therapy to first documented disease progression or death from any cause, assessed up to 36 months
Secondary outcomes (2)
Objective Response Rate
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.
Measured: Best overall response during the first 12 months after initiation of anti-PD-1/PD-L1 therapy
Overall Survival
Overall survival is defined as the time from initiation of anti-PD-1/PD-L1 therapy to death from any cause.
Measured: From initiation of anti-PD-1/PD-L1 therapy to death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Jun 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
- Responsible party
- Sponsor
- Investigators
- Zhiyuan Tang, Doctor, Study director, Affilication Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387512
- Sponsor's protocol ID
- 2022-L071
- Status last verified
- Mar 2026
- First submitted
- 19 May 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05387512
- Acronym / sponsor ID
- 2022-L071
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, PD-1, Beta-blocker, NSCLC, PD-L1, Real-world Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Anti-PD-1/PD-L1 Therapy Without Long-term Beta-blocker Exposure | – | Drug: Anti-PD-1/PD-L1 Therapy (Standard of Care)Patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care and had no documented long-term beta-blocker exposure during the relevant treatment period. |
| Standard Anti-PD-1/PD-L1 Therapy With Concomitant Long-term Beta-blocker Exposure | – | Drug: Anti-PD-1/PD-L1 Therapy (Standard of Care), Drug: Beta-blocker (Concomitant Exposure)Patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care and had documented concomitant long-term beta-blocker exposure during the relevant treatment period. Beta-blockers were prescribed for routine clinical indications and were not assigned by the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study included eligible patients with advanced non-small cell lung cancer who received standard anti-PD-1/PD-L1 inhibitor therapy in routine clinical practice at the Affiliated Hospital of Nantong University during the predefined study period. Clinical records and follow-up information were collected retrospectively. Patients were categorized into exposure cohorts according to documented concomitant long-term beta-blocker use during the anti-PD-1/PD-L1 treatment course.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Standard Anti-PD-1/PD-L1 Therapy With Concomitant Long-term Beta-blocker Exposure, Standard Anti-PD-1/PD-L1 Therapy Without Long-term Beta-blocker Exposure |
| 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. | Drug | Standard Anti-PD-1/PD-L1 Therapy With Concomitant Long-term Beta-blocker Exposure |
Primary outcome
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.
2 secondary outcomes
Objective Response Rate
Time frame: Best overall response during the first 12 months after initiation of anti-PD-1/PD-L1 therapy
Overall Survival
Time frame: From initiation of anti-PD-1/PD-L1 therapy to death from any cause, assessed up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyuan Tang, Doctor study director
Affilication Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.