Actively Recruiting
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)
Led by Guangzhou Institute of Respiratory Disease · Updated on 2025-01-13
60
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed primary squamous non-small cell lung cancer stage IIIB-IV
- Stable moderate to severe chronic obstructive pulmonary disease (COPD) diagnosed by GOLD2021 and related guidelines
- Blood eosinophil count between 100 and 300 /ul
- Negative test for driver genes EGFR, ALK, BRAF, ROS1, KRAS, HER2, MET, RET, and NTRK
- ECOG performance status of 0 to 2
- Suitable for first-line treatment with suglizumab, paclitaxel (albumin-bound), and carboplatin plus maintenance COPD therapy with bronchodilators or inhaled corticosteroids
- Availability of clinical records for suglizumab treatment and chemotherapy
- At least 15-day washout period if previously treated with bronchodilators or inhaled corticosteroids
- Voluntary participation with signed informed consent
You will not qualify if you...
- Presence of any other active malignant tumor besides squamous non-small cell lung cancer
- Prior systemic treatment for advanced or metastatic non-small cell lung cancer
- Diseases requiring long-term glucocorticoid use such as autoimmune diseases, asthma, nephritis, type 1 diabetes, or hyperthyroidism
- Use of oral or intravenous glucocorticoids within 1 month before screening
- Severe liver or kidney dysfunction as assessed by researchers
- Acute type I or II respiratory failure or long-term use of ventilator support
- Frequent acute exacerbations of COPD (2 or more moderate/severe episodes per year)
- Women who are pregnant, nursing, or planning pregnancy
- Current participation or planned involvement in other clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NO.28 Qiaozhong Zhong Road, Liwan District, Guangzhou City, Guangdong Province
Guangzhou, Guangdong, China, 510163
Actively Recruiting
Research Team
Z
ZHOU
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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