NCT07193641

A Study on Using SFRT With Standard Treatment for Oligoprogressive NSCLC

A Prospective, Single-Arm Phase II Clinical Trial of Standard Systemic Therapy Combined With Spatial Fractionated Radiotherapy (SFRT) for Oligoprogressive Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if spatially fractionated radiotherapy (SFRT) combined with standard systemic therapy can treat oligoprogressive non-small cell lung cancer (NSCLC) in patients who have progressed after at least one line of systemic therapy. The main question it aims to answer is: \- Can the combination of SFRT and standard systemic therapy improve progression-free survival (PFS) compared to standard systemic therapy alone? Participants will: * Undergo SFRT treatment for oligoprogressive lesions, with specific dose fractionation determined by the radiation oncologist based on clinical parameters. * Continue their standard systemic therapy, which may include chemotherapy, targeted therapy, or immunotherapy, as adjusted by their treating physician. * Have regular follow-up assessments, including imaging studies to evaluate treatment response and monitor for disease progression.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT)	The intervention includes SFRT for larger oligoprogressive lesions (≥4.5 cm in diameter), utilizing image-guided CT, including 4D-CT, with Lattice technique planning. The dose fractionation will be determined by the radiation oncologist based on clinical parameters, with peak doses ranging from 6-15 Gy/Fx and valley doses from 1.8-4 Gy/Fx, typically in 1-5 fractions. For smaller oligoprogressive lesions, stereotactic body radiotherapy (SBRT) or intensity-modulated radiotherapy (IMRT) will be selected based on clinical parameters.
DRUG	The systemic therapy	Continuation or switch of prior standard regimen (chemotherapy, targeted TKI, or PD-1/PD-L1 inhibitor) at investigator discretion until further progression or intolerable toxicity.

Timeline

• Start date: 2025-06-15
• Primary completion: 2027-06-15
• Completion: 2028-06-15
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: China