Evaluating a combination treatment for advanced lung cancer and COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Zhou
• Email: doctorzcz@163.com
• Phone: 13560351186

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer

  This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.

  Recruiting Phase 2 AeroRx Therapeutics Inc. · London and 1 other locations · NCT07896252

• Cognitive load and inhaler technique in COPD

  This study tests whether adding a short memory task while using an inhaler makes COPD patients more likely to misuse their inhaler.

  Recruiting Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara · Timișoara, Timiș County · NCT07786220

• Balance training after pulmonary rehab for COPD to help steadiness and reduce falls

  A COPD-focused balance training program called Sport4Steadiness is being tested to see if people with COPD will accept it and if the study processes work well.

  Recruiting at 3 sites Teesside University · Middlesbrough and 2 other locations · NCT07750821

• Continuous vs High-Intensity Interval Exercise in COPD

  This study tests whether continuous versus high-intensity interval exercise affects cerebral oxygenation in people with COPD.

  Recruiting George Papanicolaou Hospital · Thessaloniki, Exohi · NCT07707271

• Biomarker clues for COPD, IPF, and lung cancer

  This study tests whether inflammation, immune, genetic, and epigenetic markers at enrollment can explain how COPD, IPF, or lung cancer present and behave, in order to see if these markers can predict outcomes over a year.

  Recruiting Fondazione Don Carlo Gnocchi ETS · Milan, Milan · NCT07707245

• HRS-9821 Inhalation Suspension for COPD: Safety and Dose Finding in Adults

  This study tests whether HRS-9821 inhalation can be safely taken and help people with moderate to severe COPD, and aims to find a reasonable dose.

  Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Shanghai, Shanghai Municipality · NCT07640451

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.