Proton therapy takes aim at early lung cancer
NCT ID NCT07412327
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a precise type of radiation called stereotactic body proton therapy (SBPT) for people with early-stage non-small cell lung cancer who cannot have surgery or choose not to. About 65 participants will receive targeted proton beams in a few high-dose sessions. Researchers will track how long the cancer stays under control, survival rates, side effects, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton beam radiation (stereotactic body proton therapy)
- What this could lead to
- If successful, this could offer a precise, effective radiation option for early-stage lung cancer patients who cannot undergo surgery, potentially improving tumor control and survival.
- What could go wrong
- This is a small, single-center phase II study with only 65 participants, so results may not apply broadly. Radiation side effects to nearby organs are possible, and long-term outcomes are still being tracked.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jul 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: 1. .Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the clinical diagnosis of lung cancer is confirmed after multidisciplinary team (MDT) discussion. 2. The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1\~3 N0M0, stage IA-IIB (AJCC eighth edition). 3. Age: 18 years and above. 4. Karnofsky(KPS) score ≥60. 5. The doctor assesses that surgical treatment is not suitable or the patient refuses surgery. 6. Relatively good organ function: 7. Normal bone marrow function: white blood cell (WBC)≥3×109/L, Platelet ≥80×109/L, Hemoglobin(HGB)≥90g/L 8. Normal liver and kidney function: 9. Total bilirubin, Aspartate Aminotransferase(AST), and ALT(Alanine Aminotransferase)≤2.0×upper limit of normal values; 10. Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value 11. The patient has signed an informed consent form and is willing and able to comply with planned study visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Patients with other malignant tumors. 2. Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3). 3. Those whose laboratory test values do not meet relevant standards before enrollment. 4. Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons. 5. Women of childbearing age who have a positive pregnancy test and women who are breastfeeding. 6. Patients considered inappropriate for inclusion by other investigators.
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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
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Guangzhou Concord Cancer Center
RECRUITINGGuangzhou, Guangdong, China
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