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Enrolling by Invitation

NCT Number: NCT07167459

Personalized SBRT in Early-Stage Peripheral NSCLC

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.

Enrolling by Invitation

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Key information

Conditions

Early-stage Peripheral Non-small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060, Tianjin, Tianjin Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ndividualized Stereotactic Body Radiotherapy (SBRT) System

Device

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.

Primary outcomes

  1. 3-year overall survival (OS)

    Time frame: 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).

Secondary outcomes

  1. 3-year Progression-Free Survival (PFS)

    Time frame: Enrollment → 36 months

    Proportion of participants alive and without radiographic progression at 36 months.

  2. 3-year Local Control (LC)

    Time frame: Enrollment → 36 months

    Proportion of participants with no evidence of tumor recurrence at the irradiated site at 36 months.

  3. Objective Response Rate (ORR)

    Time frame: Enrollment → ~5 months (≈1 month to complete SBRT plus 4 months follow-up)

    Percentage of participants achieving complete or partial response per RECIST 1.1 at 4 months after SBRT completion.

  4. Adverse Event Incidence

    Time frame: Enrollment → 6 months after last SBRT fraction

    Frequency and severity of all treatment-related toxicities graded by CTCAE 5.0, collected continuously.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.