A Real World Study of β2-Adrenergic Blocker Plus PD-1 Inhibitor in Non-Small Cell Lung Cancer

NCT05387512 | Completed

• 1 other identifier: 2022-K002-01
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore an optimized treatment regimen of camrelizumab for Chinese patients with non-squamous non-small cell lung cancer. We will evaluate the efficacy, safety, and cost-effectiveness of camrelizumab monotherapy versus camrelizumab combined with a beta-adrenergic receptor blocker. Based on real-world data, a Markov model will be established to analyze the incremental cost-effectiveness of the combination therapy compared to monotherapy. Deterministic sensitivity analysis and probabilistic sensitivity analysis will be performed.

Conditions

Lung Cancer

Keywords

lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Time from randomization until first documented disease progression per RECIST v1.1 (based on CT scans) or death from any cause. Tumor assessments by CT will be performed every 12 weeks (approximately every 3 cycles) during the first year, and annually thereafter until progression. The Kaplan-Meier method will be used to estimate the median PFS and its 95% confidence interval for each group, and survival curves will be plotted. Intergroup comparisons will be performed using the log-rank test. Additionally, a Cox proportional hazards model will be constructed to estimate the hazard ratio and its 95% confidence interval.

  2022-2025

Study Arms (2)

Camrelizumab treatment group

Patients receive camrelizumab (an anti-PD-1 antibody) alone. Reference regimen of Camrelizumab 200mg/3 weeks will follow the approved product label or study protocol. This arm corresponds to the "ICB therapy" group in the foundational preclinical study.

Drug: Camrelizumab

Camrelizumab + β-blocker Combination treatment group

Patients receive camrelizumab in combination with a β2-adrenergic receptor blocker (e.g., a selective agent such as ICI-118551 used in preclinical models, or a clinically available alternative like propranolol). The specific β-blocker, dosing, and schedule will be defined in the study protocol. This arm directly tests the translational hypothesis derived from the preclinical finding that β-blockade reverses T cell exhaustion and restores sensitivity to anti-PD-1 therapy.

Drug: β-adrenergic receptor blocker; Drug: Camrelizumab

Interventions

β-adrenergic receptor blocker DRUG

A β-blocker (specifically targeting the β2-adrenergic receptor, such as the selective antagonist ICI-118551 used in preclinical models, or a clinically available agent like propranolol) will be administered in combination with Camrelizumab. The specific agent, dose, route (e.g., oral), and schedule will be defined in the study protocol.

Camrelizumab + β-blocker Combination treatment group

Camrelizumab DRUG

Camrelizumab is a humanized anti-PD-1 monoclonal antibody. The intervention will be administered as an intravenous infusion at a dose of 200 mg every 3 weeks, in accordance with the approved product label or the study protocol.

Also known as: SHR-1210

Camrelizumab + β-blocker Combination treatment group; Camrelizumab treatment group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study, pathological records and follow-up information of newly treated lung cancer patients in our hospital and four hospitals in Nanjing and Nantong from June 2022 to May 2025 were collected. Patients meeting the criteria of admission were divided into experimental group and control group.

You may qualify if:

• (1)Histologically confirmed advanced (stage IIIB/IV) NSCLC; (2) Planned to receive first-line anti-PD-1/L1 monotherapy and deemed suitable for such treatment; (3) Older than 18 years of age; (4) ECOG (Eastern Oncology Collaboration group) score 0-1; (5) Ecg and liver and kidney function are normal; (6) No second primary tumor disease or serious complications.

You may not qualify if:

• (1) Known hypersensitivity to camrelizumab or any of its excipients, or to any component of the planned β-blocker; (2) Clear contraindications to the use of a β-adrenergic receptor blocker; (3)Active infection requiring systemic therapy;(4)Any other concurrent severe illness or clinical condition that, in the investigator's judgment, would interfere with the completion or interpretation of the study protocol or increase patient risk.

Sponsors & Collaborators

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

Study Sites (1)

Department of Pharmacy, Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhiyuan Tang, Doctor

  Affilication Hospital of Nantong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: January 12, 2022
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: January 6, 2026

Record last verified: 2023-05

Locations

CN (1)