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RECRUITING
NCT07886229
PHASE1

Propranolol Hydrochloride Combined With Toripalimab and Platinum-based Chemotherapy in Resectable Non-Small Cell Lung Cancer

Sponsor: Second Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, open-label study designed to evaluate the safety and tolerability of propranolol hydrochloride in combination with toripalimab and platinum-based chemotherapy as perioperative treatment in patients with resectable non-small cell lung cancer (NSCLC). 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 resectable NSCLC.

Official title: A Prospective, Multicenter, Open-Label Study of Propranolol Hydrochloride in Combination With Toripalimab and Platinum-Based Chemotherapy as Perioperative Treatment for Resectable Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-06-01

Completion Date

2029-12-31

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

DRUG

Propranolol Hydrochloride

Oral propranolol hydrochloride will be administered at escalating dose levels using a conventional 3+3 dose-escalation design. Three planned dose levels are 10 mg BID, 10 mg TID and 20 mg BID. Propranolol will be administered in combination with neoadjuvant toripalimab and platinum-based chemotherapy, followed by postoperative maintenance treatment with propranolol and toripalimab.

DRUG

Toripalimab

Toripalimab will be administered intravenously at a dose of 240 mg on Day 1 of each 21-day cycle, in combination with propranolol hydrochloride and platinum-based chemotherapy for 3-4 neoadjuvant cycles. Following surgical resection, toripalimab will be continued as postoperative maintenance therapy according to the study protocol.

DRUG

Chemotherapy

Participants will receive platinum-based doublet chemotherapy selected according to tumor histology. For nonsquamous NSCLC, chemotherapy will consist of pemetrexed in combination with cisplatin or carboplatin. For squamous NSCLC, chemotherapy will consist of a taxane (paclitaxel, nab-paclitaxel, liposomal paclitaxel, paclitaxel polymeric micelles, or docetaxel) in combination with cisplatin or carboplatin. Chemotherapy will be administered intravenously every 3 weeks for 3-4 neoadjuvant cycles, in combination with propranolol hydrochloride and toripalimab, followed by multidisciplinary evaluation for surgical resection.

Locations (4)

The Second Xiangya Hospital of Central south University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital, Central South University

Changsha, Hunan, China