Non Small Cell Lung CancerPhase 2NCT07193641
A Study on Using SFRT With Standard Treatment for Oligoprogressive NSCLC
A Phase 2 study testing Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT) and The systemic therapy 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
The goal of this clinical trial is to learn if spatially fractionated radiotherapy (SFRT) combined with standard systemic therapy can treat oligoprogressive non-small cell lung cancer (NSCLC) in patients who have progressed after at least one line of systemic therapy. 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?
- Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT) and The systemic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 15 Jun 2028
- Phase
- Phase 2
- 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 or older, regardless of sex.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less, with an expected survival of more than 3 months.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with oligometastatic disease (up to 5 separate progressive lesions), having received and progressed after at least one line of systemic therapy (chemotherapy, targeted therapy, or immunotherapy).
- The target lesion for radiotherapy has not been previously irradiated, or it has been more than 6 months since the last radiotherapy.
- The diameter of the target lesion is at least 4.5 cm, suitable for lattice radiotherapy planning.
- No new or enlarged brain metastases; if brain metastases were previously treated with standard radiotherapy, they must be stable.
- Adequate hematologic and biochemical profiles, including hemoglobin ≥9.0 g/dL, absolute neutrophil count (ANC) ≥1500/mm³, platelet count ≥100,000/mm³, total bilirubin ≤1.5 times the upper limit of normal (ULN) (or direct bilirubin ≤ULN if total bilirubin >1.5 times ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN (or ≤5 times ULN if liver involvement is present), and creatinine ≤1.5 times ULN (or glomerular filtration rate [GFR] >60 mL/min if creatinine >1.5 times ULN).
- For women of childbearing potential, a negative pregnancy test within 7 days prior to registration.
Who cannot join
- Presence of other systemic diseases or severe comorbidities that the investigator believes would make the patient unsuitable for the study or significantly interfere with the assessment of the safety and toxicity of the study regimen.
- Active autoimmune diseases requiring systemic treatment, or a history of severe autoimmune diseases, such as interstitial lung disease.
- Uncontrolled concurrent diseases, including but not limited to: infections requiring systemic treatment, active tuberculosis (TB), severe or chronic gastrointestinal diseases associated with diarrhea (e.g., Crohn's disease), active hepatitis B (defined by positive hepatitis B surface antigen [HBsAg]), active hepatitis C (defined by positive hepatitis C virus [HCV] RNA), symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, myocardial infarction within the past 6 months, or congestive heart failure requiring continuous maintenance therapy for life-threatening ventricular arrhythmias.
- Mental illness or social situations that might limit the patient's ability to comply with study requirements (e.g., drug abuse).
- Participation in other interventional clinical trials with experimental drugs that could be considered treatment for the primary tumor.
- Allergy to immunotherapy drugs, or discontinuation of immunotherapy drugs due to adverse events in the past, or grade 3 or higher immune-related adverse events during previous immunotherapy, or any grade of immune-related neurological or ocular adverse events.
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- History of other active malignancies within the past 6 months, except for non-melanoma skin cancer, papillary thyroid cancer, prostate cancer, or cervical carcinoma in situ that have been treated with curative intent and are currently considered to have a recurrence risk of less than 30%.
- History of allogeneic organ transplantation or active primary immunodeficiency.
- Any other condition that the investigator deems a valid reason for exclusion, such as potential situations inconsistent with the clinical protocol.
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
Hangzhou, Zhejiang, 310000
Ting Zhang phD, +86571-87783521, zezht@zju.edu.cn
phD
About this study
Official title: A Prospective, Single-Arm Phase II Clinical Trial of Standard Systemic Therapy Combined With Spatial Fractionated Radiotherapy (SFRT) for Oligoprogressive Non-small Cell Lung Cancer (NSCLC)
The goal of this clinical trial is to learn if spatially fractionated radiotherapy (SFRT) combined with standard systemic therapy can treat oligoprogressive non-small cell lung cancer (NSCLC) in patients who have progressed after at least one line of systemic therapy. The main question it aims to answer is:
- Can the combination of SFRT and standard systemic therapy improve progression-free survival (PFS) compared to standard systemic therapy alone?
Read more
Participants will:
- Undergo SFRT treatment for oligoprogressive lesions, with specific dose fractionation determined by the radiation oncologist based on clinical parameters.
- Continue their standard systemic therapy, which may include chemotherapy, targeted therapy, or immunotherapy, as adjusted by their treating physician.
- Have regular follow-up assessments, including imaging studies to evaluate treatment response and monitor for disease progression.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT), The systemic therapy
- Keywords
- oligoprogressive NSCLC, SFRT, systemic therapy
- 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.
Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT)Radiation
The intervention includes SFRT for larger oligoprogressive lesions (≥4.5 cm in diameter), utilizing image-guided CT, including 4D-CT, with Lattice technique planning. The dose fractionation will be determined by the radiation oncologist based on clinical parameters, with peak doses ranging from 6-15 Gy/Fx and valley doses from 1.8-4 Gy/Fx, typically in 1-5 fractions.
For smaller oligoprogressive lesions, stereotactic body radiotherapy (SBRT) or intensity-modulated radiotherapy (IMRT) will be selected based on clinical parameters.
The systemic therapyDrug
Continuation or switch of prior standard regimen (chemotherapy, targeted TKI, or PD-1/PD-L1 inhibitor) at investigator discretion until further progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| SFRT plus systemic therapy | Experimental | Not described Receives: Radiation: Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT); Drug: The systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS will be determined based on radiological assessments using CT or MRI scans, according to the RECIST v1.1 criteria. Disease progression will be defined as an increase of at least 20% in the size of target lesions or the appearance of new lesions.
Measured: From date of first study treatment to documented progression or death, assessed at 6 weeks, 12 weeks, 24 weeks, 48 weeks, and 72 weeks.
Secondary outcomes (3)
Objective Response Rate (ORR) of Irradiated Lesions
ORR will be assessed using RECIST v1.1 criteria. ORR includes complete response (CR) and partial response (PR). Tumor response will be evaluated through radiological imaging (CT or MRI) of the irradiated lesions
Measured: 1 month after the completion of SFRT treatment and then every 3 months thereafter
Treatment-Related Adverse Events (TRAEs)
TRAEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence and severity of adverse events will be recorded at each follow-up visit, with a focus on grade 3 or higher events
Measured: throughout the treatment period and for a predefined follow-up period, typically up to 12 months after treatment completion
Overall Survival (OS)
OS will be determined based on the date of death recorded in medical records or through follow-up contacts with patients or their families
Measured: From date of first study treatment to death from any cause, assessed at 24 weeks, 48 weeks, and 72 weeks.
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 start15 Jun 2025
- Primary completion15 Jun 2027 (estimated)
- Study completion15 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193641
- Sponsor's protocol ID
- Y202-0552
- Status last verified
- Jun 2025
- First submitted
- 10 Aug 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Phase II Clinical Trial of Standard Systemic Therapy Combined With Spatial Fractionated Radiotherapy (SFRT) for Oligoprogressive Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07193641
- Acronym / sponsor ID
- Y202-0552
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- oligoprogressive NSCLC, SFRT, systemic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 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.
The goal of this clinical trial is to learn if spatially fractionated radiotherapy (SFRT) combined with standard systemic therapy can treat oligoprogressive non-small cell lung cancer (NSCLC) in patients who have progressed after at least one line of systemic therapy. The main question it aims to answer is:
- Can the combination of SFRT and standard systemic therapy improve progression-free survival (PFS) compared to standard systemic therapy alone?
Participants will:
- Undergo SFRT treatment for oligoprogressive lesions, with specific dose fractionation determined by the radiation oncologist based on clinical parameters.
- Continue their standard systemic therapy, which may include chemotherapy, targeted therapy, or immunotherapy, as adjusted by their treating physician.
- Have regular follow-up assessments, including imaging studies to evaluate treatment response and monitor for disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SFRT plus systemic therapy | Experimental | Radiation: Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT), Drug: The systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older, regardless of sex.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less, with an expected survival of more than 3 months.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with oligometastatic disease (up to 5 separate progressive lesions), having received and progressed after at least one line of systemic therapy (chemotherapy, targeted therapy, or immunotherapy).
- The target lesion for radiotherapy has not been previously irradiated, or it has been more than 6 months since the last radiotherapy.
- The diameter of the target lesion is at least 4.5 cm, suitable for lattice radiotherapy planning.
Key exclusion criteria (9 listed)
- Presence of other systemic diseases or severe comorbidities that the investigator believes would make the patient unsuitable for the study or significantly interfere with the assessment of the safety and toxicity of the study regimen.
- Active autoimmune diseases requiring systemic treatment, or a history of severe autoimmune diseases, such as interstitial lung disease.
- Uncontrolled concurrent diseases, including but not limited to: infections requiring systemic treatment, active tuberculosis (TB), severe or chronic gastrointestinal diseases associated with diarrhea (e.g., Crohn's disease), active hepatitis B (defined by positive hepatitis B surface antigen [HBsAg]), active hepatitis C (defined by positive hepatitis C virus [HCV] RNA), symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, myocardial infarction within the past 6 months, or congestive heart failure requiring continuous maintenance therapy for life-threatening ventricular arrhythmias.
- Mental illness or social situations that might limit the patient's ability to comply with study requirements (e.g., drug abuse).
- Participation in other interventional clinical trials with experimental drugs that could be considered treatment for the primary tumor.
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 |
|---|---|---|
| Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT)The intervention includes SFRT for larger oligoprogressive lesions (≥4.5 cm in diameter), utilizing image-guided CT, including 4D-CT, with Lattice technique planning. The dose fractionation will be determined by the radiation oncologist based on clinical parameters, with peak doses ranging from 6-15 Gy/Fx and valley doses from 1.8-4 Gy/Fx, typically in 1-5 fractions. For smaller oligoprogressive lesions, stereotactic body radiotherapy (SBRT) or intensity-modulated radiotherapy (IMRT) will be selected based on clinical parameters. | Radiation | SFRT plus systemic therapy |
| The systemic therapyContinuation or switch of prior standard regimen (chemotherapy, targeted TKI, or PD-1/PD-L1 inhibitor) at investigator discretion until further progression or intolerable toxicity. | Drug | SFRT plus systemic therapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From date of first study treatment to documented progression or death, assessed at 6 weeks, 12 weeks, 24 weeks, 48 weeks, and 72 weeks.
PFS will be determined based on radiological assessments using CT or MRI scans, according to the RECIST v1.1 criteria. Disease progression will be defined as an increase of at least 20% in the size of target lesions or the appearance of new lesions.
3 secondary outcomes
Objective Response Rate (ORR) of Irradiated Lesions
Time frame: 1 month after the completion of SFRT treatment and then every 3 months thereafter
Treatment-Related Adverse Events (TRAEs)
Time frame: throughout the treatment period and for a predefined follow-up period, typically up to 12 months after treatment completion
Overall Survival (OS)
Time frame: From date of first study treatment to death from any cause, assessed at 24 weeks, 48 weeks, and 72 weeks.
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 26 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT) and The systemic therapy 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 8 inclusion and 9 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 26 Sep 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ting Zhang, phD. (+8657187783521, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From date of first study treatment to documented progression or death, assessed at 6 weeks, 12 weeks, 24 weeks, 48 weeks, and 72 weeks.). 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 26 Sep 2025.