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)
| NCT ID | NCT06772454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou Institute of Respiratory Disease |
| Condition | Lung Cancer Squamous Cell |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-01-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * This project is a multi-center, randomized controlled, intentionality analysis study. Inclusion criteria: 1. Age ≥18 years old; 2. Histological or cytological examination confirmed clinically primary squamous non-small cell lung cancer stage IIIB-IV (according to AJCC 8th Edition); 3. 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; 4. The gene test showed that the driver gene (EGFR/ALK/BRAF/ROS1/KRAS/ HER2/MET/RET /NTRK) was negative; 5. ECOG PS 0-2 points; 6. 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; 7. Clinical records of suglizumab treatment, chemotherapy and other treatments are available; 8. Patients who have previously used bronchodilators and inhaled corticosteroids should undergo a washout period of at least 15 days; 9. Patients voluntarily join the project and sign informed consent; Exclusion Criteria: * 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06772454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer Squamous Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06772454 currently recruiting?
Yes, NCT06772454 is actively recruiting participants. Contact the research team at doctorzcz@163.com for enrollment information.
Where is the NCT06772454 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06772454 clinical trial?
NCT06772454 is sponsored by Guangzhou Institute of Respiratory Disease. The trial plans to enroll 60 participants.
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