Evaluating a combination treatment for advanced lung cancer and COPD

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)

This study is testing a new combination treatment for people with advanced lung cancer and COPD to see if it helps them feel better and manage both conditions more effectively.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangzhou Institute of Respiratory Disease (Academic / other)
• Drugs / interventions: suglizumab, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06772454 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of a treatment regimen that combines inhaled corticosteroids, bronchodilators, a PD-L1 inhibitor, and platinum-based chemotherapy in patients suffering from advanced lung squamous cell carcinoma along with chronic obstructive pulmonary disease (COPD). It is a multi-center, randomized controlled study that focuses on patients with specific inclusion criteria, including confirmed lung cancer and stable COPD. The study will analyze the outcomes of this combination therapy to determine its effectiveness in managing both conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced lung squamous cell carcinoma and stable moderate to severe COPD.

Not a fit: Patients with driver gene mutations or those with severe COPD may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced lung cancer and COPD.

How similar studies have performed: While similar approaches have been explored, this specific combination treatment is novel and has not been extensively tested in prior studies.

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;

Where this trial is running

Guangzhou, Guangdong

• NO.28 Qiaozhong Zhong Road, Liwan District, Guangzhou City, Guangdong Province — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zhou

Conditions Lung Cancer Squamous Cell; COPD