Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT05979818

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

Led by Second Xiangya Hospital of Central South University · Updated on 2024-11-19

6

Participants Needed

1

Research Sites

111 weeks

Total Duration

On this page

Sponsors

S

Second Xiangya Hospital of Central South University

Lead Sponsor

I

Innovent Biologics (Suzhou) Co. Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent before any study procedures
  • Age between 18 and 75 years
  • ECOG performance status score of 0 to 1
  • Expected survival time of at least 12 weeks
  • Histologically or cytologically confirmed stage IIIB-IIIC or stage IV non-small cell lung cancer without prior systemic therapy for advanced disease
  • No EGFR gene-sensitive mutation, ALK gene fusion, or ROS1 gene fusion in non-squamous carcinoma
  • At least one measurable lesion by imaging (RECIST version 1.1)
  • Brain metastases allowed if asymptomatic or stabilized after local treatment and meeting specific conditions
  • Adequate blood counts and organ function as defined by laboratory tests within 14 days before treatment
  • New York Heart Association (NYHA) class less than 3 and left ventricular ejection fraction of at least 50%
  • Negative pregnancy test for females of childbearing potential within 3 days before first treatment
  • Use of effective contraception during treatment and for up to 120 days after treatment end
Not Eligible

You will not qualify if you...

  • Participation in another interventional clinical study or use of investigational drugs recently
  • Prior treatment with anti-PD-1, anti-PD-L1, CTLA-4, or other T-cell checkpoint therapies
  • Recent use of systemic Chinese medicines with anti-tumor effects or immunomodulatory drugs within 2 weeks
  • Use of oral or intravenous beta-blockers that cannot be safely discontinued
  • Contraindications to beta-blockers including asthma, severe bradycardia, cardiogenic shock, heart failure class III/IV, hypotension, severe peripheral vascular disease, and others
  • Severe or unstable lung disease such as severe asthma or COPD
  • Uncontrolled diabetes mellitus with high blood sugar or HbA1C
  • Recent major surgery or palliative radiotherapy within specified time frames
  • Known symptomatic central nervous system metastases or carcinomatous meningitis
  • Active infections including tuberculosis, hepatitis B or C, syphilis, or serious uncontrolled infections
  • History of primary immunodeficiency or ongoing immunosuppressive therapy
  • History of other cancers within 5 years except adequately treated certain skin or in situ cancers
  • Pregnant or breastfeeding females
  • Other medical or psychiatric conditions that increase risk or interfere with study participation, as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Second Xiangya Hospital of Central south University

Changsha, Hunan, China, 410011

Actively Recruiting

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Research Team

F

Fang Wu, M.D, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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