Precision radiation aims to control early lung cancer without surgery
NCT ID NCT07167459
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase II trial is testing whether personalized stereotactic body radiotherapy (SBRT) can safely control early-stage peripheral non-small cell lung cancer. The treatment delivers high-dose radiation precisely to the tumor while sparing healthy tissue. Researchers will follow 251 patients for three years to see how many remain alive and cancer-free.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stereotactic body radiotherapy (SBRT) delivered via a robotic radiosurgery platform
- What this could lead to
- If successful, this could confirm that personalized SBRT is a safe and effective alternative to surgery for early-stage lung cancer patients who cannot or choose not to have surgery.
- What could go wrong
- This is a phase II trial, so results are still preliminary. The treatment may not control the tumor long-term or could cause side effects like lung inflammation or damage to nearby tissues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 251 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060
Tianjin, Tianjin Municipality, 300381, China
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Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060
Tianjin, Tianjin Municipality, China