NCT06772454Recruiting
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)
Source: ClinicalTrials.gov · Last updated 13 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 2 Jan 2025
- Start date
- 1 Jan 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Diseases
- COPD, Lung cancer
- NCT number
- NCT06772454
What you commit to
- Study type: Observational
- Planned participants: 60
- From 1 Jan 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 10\. Concurrent with any malignant active tumor other than squamous non-small cell lung cancer; 11. Prior systematic treatment for advanced/metastatic non-small cell lung cancer; 12. Patients with diseases requiring long-term oral or intravenous use of glucocorticoids, such as autoimmune diseases, asthma, nephritis, type 1 diabetes, hyperthyroidism, etc.; Etc.; 13. Oral or intravenous use of glucocorticoids for any reason within 1 month prior to screening; 14. The patient was assessed by the researchers as having severe liver and kidney dysfunction; 15. Accompanied by acute type I/II respiratory failure or long-term use of non-invasive or invasive ventilator assisted ventilation or frequent acute exacerbations (≥2 times/year of moderate and severe acute exacerbations); 16. Women who are pregnant or nursing, or who are planning to become pregnant; Currently receiving or planning to participate in any other clinical studies;
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NO.28 Qiaozhong Zhong Road, Liwan District, Guangzhou City, Guangdong Province Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.