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
Location: See location...
Intervention Type: Drug
Study Type: Observational
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• This project is a multi-center, randomized controlled, intentionality analysis study.

⁃ Age ≥18 years old;

⁃ Histological or cytological examination confirmed clinically primary squamous non-small cell lung cancer stage IIIB-IV (according to AJCC 8th Edition);

⁃ Patients with stable moderate to severe chronic obstructive pulmonary disease (COPD) were diagnosed according to the GOLD2021 standard and the Guidelines for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (Revised 2021), with blood eosinophils ≤300 /ul and ≥100 /ul;

⁃ The gene test showed that the driver gene (EGFR/ALK/BRAF/ROS1/KRAS/ HER2/MET/RET /NTRK) was negative;

⁃ ECOG PS 0-2 points;

⁃ Clinical evaluation is suitable for suglizumab combined with paclitaxel (albumin-bound) and carboplatin anti-tumor first-line therapy, as well as chronic obstructive pulmonary maintenance therapy with long-acting bronchodilators or inhaled corticosteroids;

⁃ Clinical records of suglizumab treatment, chemotherapy and other treatments are available;

⁃ Patients who have previously used bronchodilators and inhaled corticosteroids should undergo a washout period of at least 15 days;

⁃ Patients voluntarily join the project and sign informed consent;

Locations
Other Locations
China
NO.28 Qiaozhong Zhong Road, Liwan District, Guangzhou City, Guangdong Province
RECRUITING
Guangzhou
Contact Information
Primary
ZHOU
doctorzcz@163.com
13560351186
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-12-12
Participants
Target number of participants: 60
Treatments
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.
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.
Sponsors
Leads: Guangzhou Institute of Respiratory Disease

This content was sourced from clinicaltrials.gov

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