NCT05578222

Pembrolizumab as First-line Treatment for Advanced NSCLC Complicated With COPD

Efficacy and Safety of Pembrolizumab as First-line Treatment for Advanced Non-small Cell Lung Cancer Complicated With Chronic Obstructive Pulmonary Disease: a Prospective, Single-arm, Single-center Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• NSCLC With COPD

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab, 200mg i.v. gtt,D1,Q3W,

Timeline

• Start date: 2022-10-10
• Primary completion: 2023-12-12
• Completion: 2024-12-12
• First posted: 2022-10-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: China