Personalized SBRT in Early-Stage Peripheral NSCLC

NCT07167459 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Phase

Phase 2

Started

2023-08-04

Last updated

2025-09-11

Condition(s) studied

Early-stage Peripheral Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

ndividualized Stereotactic Body Radiotherapy (SBRT) System

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria * Participant or legal guardian provides written informed consent. * Age ≥18 years; no upper age limit; male or female. * Pathologically confirmed non-small-cell lung cancer (NSCLC) staged T1-2N0M0 (IA-IIA, AJCC 8th ed.). * Peripheral tumor location: ≥2 cm from the proximal bronchial tree or any mediastinal structure. * Medically inoperable (e.g., FEV1 \<40 % predicted, DLCO \<40 % predicted, NYHA class III-IV heart failure) or refusal of surgery. * ECOG performance status 0-2. * Life expectancy ≥6 months per investigator judgment. * Measurable disease by RECIST 1.1. * Adequate organ function (blood counts, liver and renal indices) per institutional standards. * Willing and able to comply with all study procedures, imaging schedules, and follow-up visits. * Effective contraception for women of child-bearing potential and fertile men for 12 months after SBRT completion. Exclusion Criteria * Previous thoracic radiotherapy, chemotherapy, targeted therapy, or surgery for lung cancer. * Evidence of regional or distant metastases. * Concurrent or prior malignancy within 5 years (except adequately treated basal-cell carcinoma of skin or carcinoma in situ of cervix). * Active interstitial pneumonitis, radiation pneumonitis, drug-induced pneumonitis, or clinically significant pulmonary fibrosis. * Pregnancy, lactation, or planned pregnancy. * Participation in another interventional clinical trial with an unmet primary endpoint. * Known psychiatric disorder, substance abuse, or other condition that would impair compliance. * Contraindication to contrast-enhanced CT or PET-CT imaging. * Investigator-determined medical, social, or psychological contraindications that could compromise safety or data integrity.

Primary outcome measure(s)

3-year overall survival (OS) — Approximately 36 months after enrollment
Three-year overall survival is defined as the proportion of participants who remain alive at 36 months from the start of individualized stereotactic body radiotherapy (SBRT).

Trial sites (2)

Facility	City	Region	Status
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060	Tianjin	Tianjin Municipality
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060	Tianjin	Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07167459 on ClinicalTrials.gov ↗ ← All trials in China