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Enrolling by invitation NCT07167459

Personalized SBRT in Early-Stage Peripheral NSCLC

Phase II Interventional Early-stage Peripheral Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ndividualized Stereotactic Body Radiotherapy (SBRT) System.
Who it may be relevant to
Registry conditions: Early-stage Peripheral Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 protoco

Primary outcome measures

  • 3-year overall survival (OS) [Time frame: Approximately 36 months after enrollment]
Secondary outcome measures (4)
  • 3-year Progression-Free Survival (PFS) [Time frame: Enrollment → 36 months]
  • 3-year Local Control (LC) [Time frame: Enrollment → 36 months]
  • Objective Response Rate (ORR) [Time frame: Enrollment → ~5 months (≈1 month to complete SBRT plus 4 months follow-up)]
  • Adverse Event Incidence [Time frame: Enrollment → 6 months after last SBRT fraction]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer — Tianjin
  • Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer — Tianjin

Identifiers

NCT: NCT07167459 · E20230372 · TZ3582022-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗