EFFICACY AND SAFETY OF THE COMBINATION OF PEG-RHG-CSF WITH CAMRELIZUMAB AND CHEMOTHERAPY IN ADVANCED SQUAMOUS NONSMALL CELL LUNG CANCER: A RANDOMIZED CONTROLLED TRIAL

Tong ZHAO, Tingting ZHU, Lei CHEN, Weike ZHANG

Eurasian Journal of Medicine and Oncology - 2026;10(4):1-16

Department of Oncology, The Eighth People's Hospital of Jinan City, Jinan, Shandong, China

 

Introduction: Optimizing first-line chemoimmunotherapy for advanced squamous non-small cell lung cancer (sqNSCLC) remains challenging, particularly in balancing efficacy with treatment-related hematologic toxicity. Objective: This study aims to evaluate whether adding polyethylene glycol-recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) to first-line camrelizumab and platinum-based chemotherapy improves outcomes in patients with advanced sqNSCLC. Methods: In this single-center, randomized controlled trial, 212 patients with treatment-naïve stage IV sqNSCLC were enrolled between 2020 and 2021. Among them, 23 were lost to follow-up, leaving 189 patients included in the study. They were randomly assigned (1:1) to receive either camrelizumab, paclitaxel, and carboplatin (control group, n = 94) or the same regimen plus prophylactic PEG-rhG-CSF (experimental group, n = 95). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and safety. Results: Among the evaluable patients, the ORR was significantly higher in the experimental group (58.95% vs. 43.62%; p = 0.0355). The disease control rate was comparable between groups (85.26% vs. 76.60%; p = 0.2431). The experimental group demonstrated significantly longer median PFS (10.5 vs. 8.4 months; hazard ratio [HR] = 0.72, 95% confidence interval [CI] 0.52-0.99; p = 0.0423) and a strong trend toward improved median OS (not reached vs. 22.3 months; HR = 0.67, 95% CI 0.45-0.99; p = 0.0432). Survival benefit was consistent across all predefined subgroups. The incidence of neutropenia was significantly lower in the experimental group (p < 0.0001), while fever was more common ( p = 0.0256). Other adverse events were similar between groups. Conclusion: The addition of PEG-rhG-CSF to first-line camrelizumab-based chemoimmunotherapy in advanced sqNSCLC significantly improved tumor response and PFS, showed a promising OS benefit, reduced chemotherapy-induced neutropenia, and maintained a manageable safety profile. These findings suggest a potential synergistic role for PEG-rhG-CSF beyond supportive care in this setting.