Early-Stage Lung CancerNCT07412327
Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Lung Cancer
A study testing Stereotactic Body Proton Therapy in people with Early-Stage Lung Cancer and Lung Cancer, run by Guangzhou Concord Cancer Center at 1 site in China.
Trial summary
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early-Stage Lung Cancer, Lung Cancer
- What is being tested?
- Stereotactic Body Proton Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .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.
- The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1~3 N0M0, stage IA-IIB (AJCC eighth edition).
- Age: 18 years and above.
- Karnofsky(KPS) score ≥60.
- The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
- Relatively good organ function:
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- Normal bone marrow function: white blood cell (WBC)≥3×109/L, Platelet ≥80×109/L, Hemoglobin(HGB)≥90g/L
- Normal liver and kidney function:
- Total bilirubin, Aspartate Aminotransferase(AST), and ALT(Alanine Aminotransferase)≤2.0×upper limit of normal values;
- Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
- 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.
Who cannot join
- Patients with other malignant tumors.
- Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
- Those whose laboratory test values do not meet relevant standards before enrollment.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
- Patients considered inappropriate for inclusion by other investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Concord Cancer Center
Guangzhou, Guangdong
Juan Nie, 8620-32506195, juan.nie@ccm.cn
About this study
Official title: A Single-Center, Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer. The prescribed dose for patients with peripheral lung cancer is 48-60Gray(Gy) (Relative Biological Effectiveness, RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.
- Conditions
- Early-Stage Lung Cancer, Lung Cancer
- Being tested
- Stereotactic Body Proton Therapy
- Keywords
- Proton therapy, hypofractionated radiotherapy, radiotherapy, Early-Stage Lung Cancer, lung cancer, SBPT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Proton TherapyRadiation
Also called proton hypofractionated radiotherapy
They were divided into peripheral type and central type according to the tumor location and received radical SBPT for Early-Stage Non-Small Cell Lung Cancer. . The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Proton Therapy | Experimental | The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. Receives: Radiation: Stereotactic Body Proton Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression Free Survival(PFS) is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method
Measured: Up to 3 years
Secondary outcomes (5)
Overall Survival
Overall Survival (OS) is defined as time from initiation of SBPT to patient death from any cause. Estimated by the Kaplan-Meier method.
Measured: UP to 3 years
Local Control Rate
Local control rate is defined as the proportion of participants with the absence of local failure among patients evaluable for efficacy in three years.
Measured: Up to 3 years
Quality of life scores
European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30 (EORTC QLQ-C30) (V3.0) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit
Measured: Up to 3 years
Quality of life scores
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 29(EORTC QLQ-LC29) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit
Measured: Up to 3 years
Rate of grade 3-5 adverse events
The proportion of subjects with toxic reactions of levels 3, 4 and 5 during the clinical trial period.The researchers record adverse events(AE) that appeared during the clinical trial cycle and grade it according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start24 Feb 2026
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Stage Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Concord Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taize Yuan, Doctor, Study chair, Guangzhou Concord Cancer Center,Guangzhou, Guangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412327
- Sponsor's protocol ID
- 2025-IIT-002
- Status last verified
- May 2026
- First submitted
- 9 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes. I plan to share relevant non-confidential research progress and academic achievements of this IPD with peer researchers through academic exchanges and academic conferences, while strictly keeping core confidential data undisclosed to comply with clinical research confidentiality rules.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07412327
- Acronym / sponsor ID
- 2025-IIT-002
- Conditions
- Early-Stage Lung Cancer, Lung Cancer
- Keywords
- Proton therapy, hypofractionated radiotherapy, radiotherapy, Early-Stage Lung Cancer, lung cancer, SBPT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Guangzhou Concord Cancer CenterUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer. The prescribed dose for patients with peripheral lung cancer is 48-60Gray(Gy) (Relative Biological Effectiveness, RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Proton Therapy | Experimental | Radiation: Stereotactic Body Proton TherapyThe prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- .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.
- The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1~3 N0M0, stage IA-IIB (AJCC eighth edition).
- Age: 18 years and above.
- Karnofsky(KPS) score ≥60.
- The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
Key exclusion criteria (6 listed)
- Patients with other malignant tumors.
- Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
- Those whose laboratory test values do not meet relevant standards before enrollment.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Proton TherapyAlso: proton hypofractionated radiotherapyThey were divided into peripheral type and central type according to the tumor location and received radical SBPT for Early-Stage Non-Small Cell Lung Cancer. . The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. | Radiation | Stereotactic Body Proton Therapy |
Primary outcome
Progression-free Survival
Time frame: Up to 3 years
Progression Free Survival(PFS) is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method
5 secondary outcomes
Overall Survival
Time frame: UP to 3 years
Local Control Rate
Time frame: Up to 3 years
Quality of life scores
Time frame: Up to 3 years
Quality of life scores
Time frame: Up to 3 years
Rate of grade 3-5 adverse events
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. Yes. I plan to share relevant non-confidential research progress and academic achievements of this IPD with peer researchers through academic exchanges and academic conferences, while strictly keeping core confidential data undisclosed to comply with clinical research confidentiality rules.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taize Yuan, Doctor study chair
Guangzhou Concord Cancer Center,Guangzhou, Guangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Proton Therapy in people with Early-Stage Lung Cancer and Lung Cancer, run by Guangzhou Concord Cancer Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taize Yuan Professor, Doctor (8620-32506160, taize.yuan@ccm.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.