Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Gemcitabine

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Pemetrexed

Cisplatin

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Patients receive propranolol hydrochloride PO BID, pembrolizumab IV over 30 minutes of day 1 and chemotherapy IV. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

10 mg, PO, BID, for up to 2 years until disease progression/intolerable toxicity/withdrawal of informed consent.

Propranolol hydrochloride

intravenous infusion (IV), 200 mg, Day1, Q3W, for up to 2 years until disease progression/intolerable toxicity/withdrawal of informed consent.

Sintilimab

Platinum-based chemotherapy:

For non-squamous cell carcinoma options: carboplatin/cisplatin + pemetrexed; For squamous cell carcinoma: carboplatin/cisplatin + paclitaxel/gemcitabine. Carboplatin: IV, AUC 5, Day1, Q3W; Cisplatin: IV, 75 mg/m2, Day1-3, Q3W; Pemetrexed: IV, 500 mg/m2, Day1, Q3W; Paclitaxel: IV, 175 mg/m², Day1, Q3W; Albumin-bound paclitaxel: IV, 100 mg/m², Day1, 8, 15; or 260 mg/m2, Q3W; Gemcitabine: IV, 1000mg/m2, Day1, 8, Q3W; After 4-6 cycles of sintilimab and platinum-based chemotherapy, the patients of non-squamous cell carcinoma will be received with sintilimab and pemetrexed for maintenance therapy, for up to 2 years until disease progression/intolerable toxicity/withdrawal of informed consent.

Chemotherapy

Fang Wu, M.D, Ph.D

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.

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

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

The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Disease Control Rate (DCR) The proportion of patients with a complete response or partial response or stable disease to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Based on the physical examination, vital signs, laboratory findings, and medical examinations, and record the type, incidence, severity of AEs, which were graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial