NCT07167459Enrolling by invitationPhase 2
Personalized SBRT in Early-Stage Peripheral NSCLC
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 251 (estimated)
- First submitted
- 4 Sept 2025
- Start date
- 4 Aug 2023
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07167459
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 251
- From 4 Aug 2023 to the primary completion date, 1 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous thoracic radiotherapy, chemotherapy, targeted therapy, or surgery for lung cancer.
Other illness
- 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.
- Known psychiatric disorder, substance abuse, or other condition that would impair compliance.
Other
- Evidence of regional or distant metastases.
- Pregnancy, lactation, or planned pregnancy.
- Participation in another interventional clinical trial with an unmet primary endpoint.
- Contraindication to contrast-enhanced CT or PET-CT imaging.
- Investigator-determined medical, social, or psychological contraindications that could compromise safety or data integrity.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.