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

NCT05979818 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-19

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer
  • Propranolol

Interventions

DRUG

Propranolol hydrochloride

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

DRUG

Sintilimab

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

DRUG

Chemotherapy

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • Second Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2025-08-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05979818 on ClinicalTrials.gov