Non-Small Cell Lung CancerHP-SIB-AHFRTNCT07823855
SIB Accelerated Hyperfractionated RT for High-Proliferation NSCLC
A study testing hyperfractionated radiotherapy in people with Non-Small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung… 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?
- hyperfractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to 16 Jun 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
- Age ≥ 18 years, male or female;
- Histologically or cytologically confirmed high-proliferation non-small cell lung cancer (NSCLC);
- Assessed by a multidisciplinary team (MDT) and planned to receive thoracic radiotherapy (either curative or palliative), regardless of stage.
Who cannot join
- Small cell histology;
- Severe cardiac disease (New York Heart Association [NYHA] functional class ≥ III, uncontrolled arrhythmia, or myocardial infarction within the past 6 months);
- Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use effective contraceptive measures;
- Concurrent participation in other interventional clinical trials;
- Other conditions deemed by the investigator to make the patient unsuitable for enrollment (e.g., severe mental illness).
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
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: A Single-arm Phase I/II Clinical Study of Simultaneous Integrated Boost Accelerated Hyperfractionated Radiotherapy for High-proliferation Non-small Cell Lung Cancer
This is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung cancer (NSCLC).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- hyperfractionated radiotherapy
- Keywords
- non-small cell lung cancer, hyperfractionated radiotherapy
- 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.
hyperfractionated radiotherapyRadiation
simultaneous integrated boost accelerated hyperfractionated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| hyperfractionated radiotherapy | Experimental | simultaneous integrated boost accelerated hyperfractionated radiotherapy Receives: Radiation: hyperfractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Treatment-Related Toxicity
The incidence and severity of acute treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From the start of radiotherapy through 90 days after completion of radiotherapy.
Incidence of Late Treatment-Related Toxicity
The incidence and severity of late treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy.
Secondary outcomes (3)
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Measured: Every 3 months after completion of radiotherapy, up to 2 years.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to RECIST version 1.1.
Measured: From enrollment until documented disease progression or death from any cause, up to 2 years.
Overall Survival (OS)
Overall survival is defined as the time from enrollment to death from any cause.
Measured: From enrollment until death from any cause, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start16 Jun 2026
- Primary completion16 Jun 2028 (estimated)
- Study completion16 Jun 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting Zhang, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823855
- Sponsor's protocol ID
- 2026-0539
- Acronym
- HP-SIB-AHFRT
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase I/II Clinical Study of Simultaneous Integrated Boost Accelerated Hyperfractionated Radiotherapy for High-proliferation Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07823855
- Acronym / sponsor ID
- HP-SIB-AHFRT / 2026-0539
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, hyperfractionated radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 16 Jun 2028 (estimated)
- Study completion
- 16 Jun 2028 (estimated)
- First posted
- 16 Sep 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 is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperfractionated radiotherapy | Experimental | Radiation: hyperfractionated radiotherapysimultaneous integrated boost accelerated hyperfractionated radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years, male or female;
- Histologically or cytologically confirmed high-proliferation non-small cell lung cancer (NSCLC);
- Assessed by a multidisciplinary team (MDT) and planned to receive thoracic radiotherapy (either curative or palliative), regardless of stage.
Key exclusion criteria (5 listed)
- Small cell histology;
- Severe cardiac disease (New York Heart Association [NYHA] functional class ≥ III, uncontrolled arrhythmia, or myocardial infarction within the past 6 months);
- Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use effective contraceptive measures;
- Concurrent participation in other interventional clinical trials;
- Other conditions deemed by the investigator to make the patient unsuitable for enrollment (e.g., severe mental illness).
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 |
|---|---|---|
| hyperfractionated radiotherapysimultaneous integrated boost accelerated hyperfractionated radiotherapy | Radiation | hyperfractionated radiotherapy |
Primary outcome
Incidence of Acute Treatment-Related Toxicity
Time frame: From the start of radiotherapy through 90 days after completion of radiotherapy.
The incidence and severity of acute treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Incidence of Late Treatment-Related Toxicity
Time frame: From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy.
The incidence and severity of late treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Every 3 months after completion of radiotherapy, up to 2 years.
Progression-Free Survival (PFS)
Time frame: From enrollment until documented disease progression or death from any cause, up to 2 years.
Overall Survival (OS)
Time frame: From enrollment until death from any cause, up to 2 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 16 Sep 2026.
- 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.
Ting Zhang principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperfractionated radiotherapy in people with Non-Small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 5 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 16 Sep 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 Lu Wang (+86 057137826869, dluwang0727@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Treatment-Related Toxicity (time frame: From the start of radiotherapy through 90 days after completion of 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 16 Sep 2026.