NCT05979818: BRIO

Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer

Recruiting now Phase 1 Last updated 19 November 2024

What this trial tests

Phase 1 trial testing Propranolol hydrochloride in Non Small Cell Lung Cancer in 6 participants. Currently enrolling.

Timeline

13 November 2024

Primary endpoint
31 August 2025

31 December 2026

Quick facts

Lead sponsor	Second Xiangya Hospital of Central South University
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	13 November 2024
Primary completion	31 August 2025
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

• Propranolol hydrochloride — full drug profile →
• Sintilimab — full drug profile →
• Chemotherapy (chemotherapy) — full drug profile →

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Propranolol — all drugs for Propranolol →

Sponsor

Second Xiangya Hospital of Central South University

Who can join

Adults 18 to 75, any sex, with Non Small Cell Lung Cancer or Propranolol. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective single-center Phase I clinical study in patients with EGFR/ALK/ROS1 driver oncogene negative, and advanced or metastatic NSCLC. This study is to evaluate the efficacy and safety preliminarily in a small-size of propranolol hydrochloride in combination with sintilimab and platinum-based chemotherapy in first-line therapy. Propranolol hydrochloride is a beta- adrenergic blocking agent which is associated with augment of immune cell responses. Propranolol hydrochloride may improve the responses of immune checkpoint inhibitors in treating patients with advanced NSCLC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association between pretreatment emotional distress and immune checkpoint inhibitor response in non-small-cell lung cancer.
   Zeng Y, Hu CH, Li YZ, Zhou JS, et al · · 2024 · cited 99× · PMID 38740994 · DOI 10.1038/s41591-024-02929-4
2. Neuro-immune crosstalk in cancer: mechanisms and therapeutic implications.
   Pu T, Sun J, Ren G, Li H. · · 2025 · cited 34× · PMID 40456735 · DOI 10.1038/s41392-025-02241-8
3. Chronic stress: a fourth etiology in tumorigenesis?
   Khan A, Song M, Dong Z. · · 2025 · cited 9× · PMID 40676620 · DOI 10.1186/s12943-025-02402-x
4. The neuro-immune axis in cancer: from mechanisms to therapeutic opportunities.
   Zhang C, Guo X, Liu P, Wang Y, et al · · 2025 · cited 6× · PMID 41152924 · DOI 10.1186/s13045-025-01748-5
5. Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
   Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
6. Peripheral Nerves in Cancer: Regulatory Roles and Therapeutic Strategies.
   Fu Y, Ge ZS, Cao QY, Li ZH, et al · · 2026 · cited 1× · PMID 41556039 · DOI 10.1002/mco2.70594
7. The Efficacy and Safety of Beta-blockers and Immune Checkpoint Inhibitors in Patients with Cancer: A Systematic Review and Meta-analysis.
   Tokunaga K, Fujiwara Y, Omori R, Sato T, et al · · 2025 · cited 1× · PMID 41176581 · DOI 10.1007/s11523-025-01184-y
8. Cancer Neoaxonogenesis: Mechanisms and Factors Involved in the Recruitment of Peripheral Nerves by Cancer Tissue.
   Blasko F, Horvathova L, Hunakova L, Krivosikova L, et al · · 2026 · PMID 42123376 · DOI 10.3390/ijms27093792