This clinical trial aims to evaluate the efficacy and safety of pembrolizumab in the first-line treatment of advanced NSCLC complicated with COPD and its influence on the course of COPD, so as to provide prospective clinical evidence for immunotherapy of NSCLC complicated with COPD in China and to guide clinical application.
This clinical study mainly includes 3 stages of screening, treatment and follow-up. Pabolivizumab at a fixed dose of 200 mg intravenous infusion on day 1 for Q3W, continued to maintain administration for no more than 35 cycles, or until the imaging proves the early termination of PD or other protocols. Imaging evaluation is performed every 6 weeks within 6 months from the first dose of pabolizumab and approximately every 12 weeks thereafter until disease progression or early withdrawal. Conduct regular safety assessments, document changes in COPD condition, track adverse events until remission or stabilization, or restore baseline levels, or receive other anti-tumor therapy; Record the combined medications. Main research objectives:Evaluation of PFS in patients with advanced NSCLC and COPD treatment of pabolivizumab. Secondary research objectives:To assess the ORR and acute exacerbation rate (times/person/year) and adverse reactions of PABLIZUMAB in patients with advanced NSCLC with COPD. Purpose of exploratory research:The expression levels of PD-L1, CD4+ and CD8+ T lymphocytes in tumor tissues of patients with NSCLC and COPD before treatment were laboratory tested, and the correlation between different COPD grades and immune cell infiltration and efficacy was explored. This study was designed as a single-armed, single-center, prospective, phase II clinical study with 30 clinical, radiographic, pulmonary function and pathologically confirmed advanced (stage IV) NSCLC combined with COPD primary treatment subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pembrolizumab, 200mg i.v. gtt,D1,Q3W,
Tianjin Chest Hospital
Tianjin, China
RECRUITINGPFS
The time from the beginning of randomization to the progression of tumor development or death for any reason.
Time frame: 30 months
ORR
The proportion of patients whose tumor volume has decreased to a prespecified value and can maintain a minimum time limit.ORR=PR+CR
Time frame: 12 months
Rate of acute exacerbations of COPD (times/year)
Acute exacerbations of COPD are coughs, sputum production, worsening of dyspnea, or increased amount of sputum, or yellow phlegm, requiring a change in medication regimen.Acute exacerbations of COPD are classified as Grades I.-III according to clinical signs.
Time frame: 30 months
adverse events
Harmful reactions that are not related to the purpose of medication under normal dosage of qualified drugs. Refer to CTCAE 5.0
Time frame: 30 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.