Non-Small Cell Lung CancerHyPROS-LCNCT07195084
To Explore the Safety and Efficacy of Hypervision Proton Surgery for Early-stage Non-small Cell Lung Cancer
A study testing Hypervision proton surgery in people with Non-Small Cell Lung Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
This study was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Hypervision proton surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 19 Sep 2028
- 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
- The patient must be at least 18 years old
- Karnofsky Performance Status > 80
- NSCLC confirmed by cytology or histology; for subjects who cannot safely obtain pathological evidence due to factors such as tumor lesion location, patient's underlying diseases, or high puncture risk, after unanimous consent of the multidisciplinary team (MDT) discussion, they meet the clinical diagnostic criteria for NSCLC based on typical imaging features (such as enhanced chest CT and/or PET/CT) combined with clinical manifestations;
- Early-stage tumors are defined as T1 (≤3cm) N0M0 based on enhanced computed tomography (CT) and positron emission tomography (PET)
- The tumor must be more than 2 cm away from the proximal bronchial tree in all directions (the proximal bronchial tree is defined as 2 cm from the distal end of the trachea, the protrusion and the named lobar bronchus up to its first bifurcation)
- FEV1 ≥ 1 L, FEV1 ≥ 40% of the predicted value (either one is sufficient); DLCO ≥ 40% of the predicted value
- The patient can tolerate PET-CT examination
- For female study participants of childbearing age, the urine or serum pregnancy test was negative within 7 days prior to the first administration of the study drug. If the result of the urine pregnancy test is positive, a blood pregnancy test is required
Who cannot join
- Other malignant tumors occurred concurrently within 2 years before enrollment
- A history of chest radiotherapy in the past
- It is planned to use other anti-tumor treatments within the regimen treatment (within 4 weeks)
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
Anhui Provincial Hospital
Hefei, Anhui, 230001
Shuanghu Yuan, PhD, 0551-62894008, yuanshuanghu@sina.com
Li Li, PhD, 0551-62894008, lililyde@163.com
About this study
Official title: A Phase I Clinical Study to Explore the Safety and Efficacy of Hypervision Proton Surgery (HyPROS) for Early-stage Non-small Cell Lung Cancer
This study was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC.
Read the detailed description
This study adopted a dose escalation protocol (an improved "two-stage two-dose group" design) to explore the safety and efficacy of visual proton surgery (single large fractionated doses of 34GyE and 39GyE) in the treatment of early peripheral NSCLC.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Hypervision proton surgery
- Keywords
- non-small cell lung cancer; Hypervision proton surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypervision proton surgeryRadiation
Proton radiaotherapy (34GyE or 39GyE)
| Study group | Role | What they receive |
|---|---|---|
| Proton radiotherpy | Experimental | Proton radiotherapy 34GyE/f or 39GyE/f Receives: Radiation: Hypervision proton surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade ≥ 3 psAEs at 1 month
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 1 month after proton radiotherapy
The incidence of grade ≥ 3 psAEs at 1 year
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 1 year after proton radiotherapy
Secondary outcomes (3)
Primary tumor control at 1 year
Primary tumor control at 1 year
Measured: 1 year after proton radiotherapy
Disease-free survival time
Disease-free survival time
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival time
Overall survival time
Measured: From date of treatment until the date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start20 Sep 2025
- Primary completion19 Sep 2027 (estimated)
- Study completion19 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Provincial Hospital
- Responsible party
- Principal investigator, Shuanghu Yuan, Anhui Provincial Hospital
- Investigators
- Shuanghu Yuan, PhD, Principal investigator, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195084
- Sponsor's protocol ID
- HyPROS
- Acronym
- HyPROS-LC
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Explore the Safety and Efficacy of Hypervision Proton Surgery (HyPROS) for Early-stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07195084
- Acronym / sponsor ID
- HyPROS-LC / HyPROS
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- non-small cell lung cancer; Hypervision proton surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Collaborators
- Anhui Provincial Hospital
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 19 Sep 2027 (estimated)
- Study completion
- 19 Sep 2028 (estimated)
- First posted
- 26 Sep 2025 (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 was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC.
Detailed description
This study adopted a dose escalation protocol (an improved "two-stage two-dose group" design) to explore the safety and efficacy of visual proton surgery (single large fractionated doses of 34GyE and 39GyE) in the treatment of early peripheral NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton radiotherpy | Experimental | Radiation: Hypervision proton surgeryProton radiotherapy 34GyE/f or 39GyE/f |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient must be at least 18 years old
- Karnofsky Performance Status > 80
- NSCLC confirmed by cytology or histology; for subjects who cannot safely obtain pathological evidence due to factors such as tumor lesion location, patient's underlying diseases, or high puncture risk, after unanimous consent of the multidisciplinary team (MDT) discussion, they meet the clinical diagnostic criteria for NSCLC based on typical imaging features (such as enhanced chest CT and/or PET/CT) combined with clinical manifestations;
- Early-stage tumors are defined as T1 (≤3cm) N0M0 based on enhanced computed tomography (CT) and positron emission tomography (PET)
- The tumor must be more than 2 cm away from the proximal bronchial tree in all directions (the proximal bronchial tree is defined as 2 cm from the distal end of the trachea, the protrusion and the named lobar bronchus up to its first bifurcation)
Key exclusion criteria (3 listed)
- Other malignant tumors occurred concurrently within 2 years before enrollment
- A history of chest radiotherapy in the past
- It is planned to use other anti-tumor treatments within the regimen treatment (within 4 weeks)
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 |
|---|---|---|
| Hypervision proton surgeryProton radiaotherapy (34GyE or 39GyE) | Radiation | Proton radiotherpy |
Primary outcome
The incidence of grade ≥ 3 psAEs at 1 month
Time frame: 1 month after proton radiotherapy
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
The incidence of grade ≥ 3 psAEs at 1 year
Time frame: 1 year after proton radiotherapy
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
3 secondary outcomes
Primary tumor control at 1 year
Time frame: 1 year after proton radiotherapy
Disease-free survival time
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival time
Time frame: From date of treatment until the date of death
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 13 Apr 2026.
- A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer: NRG Oncology RTOG 0915 (NCCTG N0927)Link provided by the sponsor.
- Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Shuanghu Yuan, PhD principal investigator
Anhui Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypervision proton surgery in people with Non-Small Cell Lung Cancer, run by Anhui Provincial Cancer Hospital 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 8 inclusion and 3 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 13 Apr 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 Shuanghu Yuan, PhD (0551-62894008, yuanshuanghu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade ≥ 3 psAEs at 1 month (time frame: 1 month after proton radiotherapy). The study lists 2 primary outcomes in all. 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 13 Apr 2026.