Personalized SBRT in Early-Stage Peripheral NSCLC

NCT ID: NCT07167459

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2029-03-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individualized SBRT for Early-Stage Peripheral NSCLC

This single-arm cohort comprises patients with newly diagnosed, early-stage peripheral non-small-cell lung cancer (T1-2N0M0, IA-IIA) who receive individualized stereotactic body radiotherapy (SBRT) as standard-of-care. Participants will be prospectively followed for 3 years to assess overall survival, local control, progression-free survival, and adverse events. Inclusion criteria: age ≥18 years, pathologically confirmed NSCLC, tumor location ≥2 cm from the proximal bronchial tree, ECOG 0-2, and medically inoperable or refusal of surgery.

Group Type: EXPERIMENTAL

ndividualized Stereotactic Body Radiotherapy (SBRT) System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Tianjin, Tianjin Municipality, China

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

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

TZ3582022-005

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E20230372

Identifier Type: -

Identifier Source: org_study_id