Abstract 348P
Background
Patients with driver gene-negative advanced non-small cell lung cancer (NSCLC) have a poor prognosis after failure of first-line therapies, with limited treatment options available. In recent years, the combined use of radiotherapy and immunotherapy, particularly in combination with immune modulators, has shown potential to enhance tumor immune responses. We conducted a single-center, prospective, open-label phase II clinical trial to evaluate the efficacy and safety of pulsed high-dose fractionated radiotherapy combined with granulocytemacrophage colony-stimulating factor (GM-CSF) and tislelizumab in driver gene-negative advanced NSCLC.
Methods
A total of 15 patients with stage IV NSCLC who were negative for EGFR/ALK/ROS1 driver mutations were enrolled. These patients, who had failed first-line therapy, received pulsed high-dose fractionated radiotherapy (5–6 Gy × 3–10 fractions) combined with GM-CSF (125 μg/m2/day, days 1–14) and tislelizumab (200 mg, every 3 weeks). The primary endpoint was objective response rate (ORR) assessed according to RECIST v1.1 criterion. Secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety.
Results
Among the 15 evaluable patients, the ORR was 40.0% (95% CI: 19.8%–63.9%) and the disease control rate (DCR) was 66.7% (95% CI: 41.7%–84.6%). The ORR within the radiotherapy field was 80.0% (95% CI: 54.8%–92.9%) and the DCR was 100.0% (95% CI: 79.6%–100.0%). The median PFS was 5.7 months (95% CI: 5.45–5.95 months) and the median OS was 22.9 months (95% CI: 22.65–23.15 months). No grade 3 or higher serious adverse events were observed. The most common treatment-related adverse events were mild leukopenia (13%) and mild pneumonia (13%).
Conclusions
Pulsed high-dose fractionated radiotherapy combined with GM-CSF and tislelizumab demonstrated substantial efficacy and favorable safety in Patients with driver gene-negative advanced NSCLC. This combination therapy strategy holds significant clinical potential for prolonging survival and improving tumor response rates. As such, it warrants further validation in larger-scale and multicenter studies.
Clinical trial identification
China Clinical Trial Registration Center PID: 236228 (https://www.chictr.org.cn/).
Funding
Has not received any funding.
Disclosure
The author has declared no conflicts of interest.