drugset / Trial / NCT05979818
Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer
Phase 1
Recruiting
6 enrolled
Second Xiangya Hospital of Central South University
Innovent Biologics (Suzhou) Co. Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2024-11-13
- Primary completion
- 2025-08-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Propranolol | Small molecule | 10 mg | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Background | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |