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)

Last updated: January 8, 2025
Sponsor: Guangzhou Institute of Respiratory Disease
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Treatment

Antitumor therapy

Inhaled preparation for COPD

Clinical Study ID

NCT06772454
CROC202315
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • This project is a multi-center, randomized controlled, intentionality analysisstudy.

Inclusion criteria:

  1. Age ≥18 years old;

  2. Histological or cytological examination confirmed clinically primary squamousnon-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 Diagnosisand Treatment of Chronic Obstructive Pulmonary Disease (Revised 2021), with bloodeosinophils ≤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 chronicobstructive pulmonary maintenance therapy with long-acting bronchodilators orinhaled corticosteroids;

  7. Clinical records of suglizumab treatment, chemotherapy and other treatments areavailable;

  8. Patients who have previously used bronchodilators and inhaled corticosteroids shouldundergo a washout period of at least 15 days;

  9. Patients voluntarily join the project and sign informed consent;

Exclusion

Exclusion Criteria:

  1. Concurrent with any malignant active tumor other than squamous non-small celllung cancer; 11. Prior systematic treatment for advanced/metastatic non-smallcell lung cancer; 12. Patients with diseases requiring long-term oral orintravenous use of glucocorticoids, such as autoimmune diseases, asthma,nephritis, type 1 diabetes, hyperthyroidism, etc.; Etc.; 13. Oral orintravenous use of glucocorticoids for any reason within 1 month prior toscreening; 14. The patient was assessed by the researchers as having severeliver and kidney dysfunction; 15. Accompanied by acute type I/II respiratoryfailure or long-term use of non-invasive or invasive ventilator assistedventilation or frequent acute exacerbations (≥2 times/year of moderate andsevere acute exacerbations); 16. Women who are pregnant or nursing, or who areplanning to become pregnant; Currently receiving or planning to participate inany other clinical studies;

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Antitumor therapy
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
December 12, 2025

Connect with a study center

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

    Guangzhou, Guangdong 510163
    China

    Active - Recruiting

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