NCT06772454

To Evaluate the Efficacy and Safety of Inhaled Corticosteroids Combined With Bronchodilators and Programmed Death-ligand 1 (PD-L1) Inhibitor Plus Platinum-based Chemotherapy in Patients With Advanced Lung Squamous Cell Carcinoma Complicated With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of inhaled corticosteroids combined with bronchodilators and programmed death-ligand 1 (PD-L1) inhibitor plus platinum-based chemotherapy in patients with advanced lung squamous cell carcinoma complicated with chronic obstructive pulmonary disease (COPD)

Conditions

• Lung Cancer Squamous Cell
• COPD

Interventions

Type	Name	Description
DRUG	Antitumor therapy	All patients received suglizumab + paclitaxel + carboplatin: Suglizumab 1200 mg IV Q3W Paclitaxel (albumin-bound) 100 mg/m2 IV, D1, 8, 15, Q3W Carboplatin AUC=5 mg/mL/min IV Q3W A total of 4 administration cycles were given, and Suglizumab 1200 mg IV Q3W was maintained after 4 administration cycles
DRUG	Inhaled preparation for COPD	60 patients were randomly assigned to the following two groups in a 1:1 ratio, with about 30 patients in each group. Group A: Receiving a long-acting beta-2 agonist (LABA) + a long-acting anticholinergic (LAMA) combination: Glonium bromide formoterol inhalation aerosol (7.2ug/5ug, trade name: Biwapin, Astrazeneca), 2 inhalations twice a day. Group B: Received inhaled glucocorticoid (ICS) +LABA+LAMA as a three-drug combination: budesonide/glononium bromide/formoterol :160ug/7.2ug/4.8ug, Astrazeneca), 2 inhalations twice daily.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-06-30
• Completion: 2025-12-12
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study