NCT07167459

Personalized SBRT in Early-Stage Peripheral NSCLC

A Phase II Trial of Personalized Definitive Stereotactic Body Radiotherapy (SBRT) for Early-Stage Peripheral Non-Small Cell Lung Cancer (NSCLC) With Correlative Omics Analysis

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to learn about the long-term safety and effectiveness of personalized stereotactic body radiotherapy (SBRT) in patients with early-stage peripheral non-small cell lung cancer (NSCLC). Individualized SBRT is a specialized radiation technique that delivers precise, high-dose treatment while minimizing damage to surrounding normal tissues. The main question it aims to answer is: Does individualized SBRT maintain local tumor control and patient survival at 3 years without significant side effects? Patients with early-stage peripheral NSCLC who are medically inoperable or refuse surgery, and who are scheduled to receive individualized SBRT as their standard treatment, will provide the data to assess the safety and efficacy of this personalized radiation approach.

Conditions

• Early-stage Peripheral Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DEVICE	ndividualized Stereotactic Body Radiotherapy (SBRT) System	The individualized SBRT system employs advanced image-guided radiation delivery to deliver highly conformal, ablative doses to early-stage peripheral non-small-cell lung cancer while minimizing exposure to surrounding normal tissues. Treatment is delivered via a state-of-the-art robotic radiosurgery platform (e.g., CyberKnife M6) according to patient-specific fractionation schedules based on tumor size and proximity to critical structures, following standard indications and institutional protocols for medically inoperable or surgically refused cases.

Timeline

• Start date: 2023-08-04
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

2 sites across 1 country: China