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
Trial Snapshot
- Phase
- Phase 2
- Status
- Enrolling By Invitation
- Enrollment
- 251
- Locations
- 2
- Primary Endpoint
- 3-year overall survival (OS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •Life expectancy ≥6 months per investigator judgment.
- •Measurable disease by RECIST 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.
Arms & Interventions
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.
Intervention: ndividualized Stereotactic Body Radiotherapy (SBRT) System (Device)
Outcomes
Primary Outcomes
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
- 3-year Progression-Free Survival (PFS)(Enrollment → 36 months)
- 3-year Local Control (LC)(Enrollment → 36 months)
- Objective Response Rate (ORR)(Enrollment → ~5 months (≈1 month to complete SBRT plus 4 months follow-up))
- Adverse Event Incidence(Enrollment → 6 months after last SBRT fraction)