Non-Small-Cell Lung CancerPhase 2NCT06434740
A Study of SBRT Combined With Puterizumab in Intrapulmonary Metastasis From NSCLC
A Phase 2 study testing Stereotactic Body Radiation Therapy，SBRT and Puterizumab in people with Non-Small-Cell Lung Cancer, run by Sir Run Run Shaw Hospital.
Trial summary
This study aims to evaluate the efficacy and safety of SBRT combined with Puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between MRD and treatment efficacy. 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?
- Stereotactic Body Radiation Therapy，SBRT and Puterizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Dec 2027
- 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
- Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past
- Voluntarily participate in this study and sign an informed consent form
- The presence of evaluable size and number of pulmonary metastases on chest CT
- There are indications for lung puncture biopsy
- General physical condition (ECOG) 0-1
- The laboratory test meets the following standards: white blood cell count>3.5 × 109/L, absolute value of neutrophils>1.8 × 109/L, platelet count ≥ 75 × 109/L, hemoglobin ≥ 100g/L; NR ≤ 1.5, and APTT ≤ 1.5 times the upper limit of normal value or partial prothrombin time (PT) ≤ 1.5 times the upper limit of normal value; Total bilirubin ≤ 1.25 times the upper limit of normal value; ALT and AST<5 times the upper limit of normal values; 24-hour creatinine clearance rate>50mL/min or blood creatinine<1.5 times the upper limit of normal value.
Who cannot join
- Unable to tolerate or refuse further immunotherapy
- Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy and Safety of Stereotactic Radiotherapy Combined With Puterizumab in Non Small Cell Lung Cancer With Intrapulmonary Metastasis：A Phase II Prospective Single Arm Clinical Study
This study aims to evaluate the efficacy and safety of SBRT combined with Puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between MRD and treatment efficacy. Through single-cell sequencing and spatial transcriptome information analysis, the underlying mechanisms will be analyzed to provide a basis for improving the new precision treatment methods for tumor immunotherapy resistance.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Stereotactic Body Radiation Therapy，SBRT, Puterizumab
- Keywords
- lung cancer, radiotherapy, immunotherapy, single-cell sequencing, SBRT, peripheral blood mononuclear cell, minimalResidual disease
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy，SBRTRadiation
The enrolled subjects will receive SBRT treatment for lung metastases.The dose segmentation is 10Gy/f, with a total dose of 50Gy/5f, once every other day.
PuterizumabDrug
Within 7-14 days after SBRT, Puterizumab should be used (dosage: recommended dosage of 200mg, intravenous infusion, infusion time of 60 minutes (± 15 minutes), once every 3 weeks (Q3W), for 6-8 months or intolerable toxicity).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The enrolled subjects will receive SBRT treatment combined with Puterizumab. Receives: Radiation: Stereotactic Body Radiation Therapy，SBRT; Drug: Puterizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response rate
The tumor response rate will evaluate the local control of lung metastases，referring to the evaluation criteria for solid tumor efficacy RECIST 1.1
Measured: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Secondary outcomes (6)
Minor Residual Lesions
Using the minimal residual disease (MRD) panel for ctDNA molecular residual detection, and through ctDNA multi-node assessment, we can dynamically monitor the therapeutic efficacy and disease recurrence.
Measured: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
progression-free survival
PFS is the time from enrollment to tumor progression or death.
Measured: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
overall survival
OS is the time from enrollment to death due to any reason.
Measured: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
RTOG acute radiation injury grading
Refer to the acute radiation injury grading standards of the United States Collaborative Group on Tumor Radiotherapy (RTOG)
Measured: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted during the entire SBRT process and monthly after SBRT for up to 12 months.
QLQ-30 score
The quality of life will be evaluated using the QLQ-30 score.
Measured: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Lymphocyte subpopulation analysis
Using flow cytometry to detect the count and percentage of lymphocytes, including CD3+, CD3+, CD4+, CD3+, CD8+, CD4+/CD8+, and CD3-CD56+.
Measured: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (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.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaonan Sun, Ph D, Study chair, Sir Runrun Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434740
- Sponsor's protocol ID
- SRRS-LCsbrt
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the research is completed, the statistical results will be published as an article.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Stereotactic Radiotherapy Combined With Puterizumab in Non Small Cell Lung Cancer With Intrapulmonary Metastasis：A Phase II Prospective Single Arm Clinical Study
- ClinicalTrials.gov ID
- NCT06434740
- Acronym / sponsor ID
- SRRS-LCsbrt
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- lung cancer, radiotherapy, immunotherapy, single-cell sequencing, SBRT, peripheral blood mononuclear cell, minimalResidual disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 May 2024 (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 aims to evaluate the efficacy and safety of SBRT combined with Puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between MRD and treatment efficacy. Through single-cell sequencing and spatial transcriptome information analysis, the underlying mechanisms will be analyzed to provide a basis for improving the new precision treatment methods for tumor immunotherapy resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Radiation: Stereotactic Body Radiation Therapy，SBRT, Drug: PuterizumabThe enrolled subjects will receive SBRT treatment combined with Puterizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age≥18
- Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past
- Voluntarily participate in this study and sign an informed consent form
- The presence of evaluable size and number of pulmonary metastases on chest CT
- There are indications for lung puncture biopsy
Key exclusion criteria (2 listed)
- Unable to tolerate or refuse further immunotherapy
- Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc
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 Radiation Therapy，SBRTThe enrolled subjects will receive SBRT treatment for lung metastases.The dose segmentation is 10Gy/f, with a total dose of 50Gy/5f, once every other day. | Radiation | experimental group |
| PuterizumabWithin 7-14 days after SBRT, Puterizumab should be used (dosage: recommended dosage of 200mg, intravenous infusion, infusion time of 60 minutes (± 15 minutes), once every 3 weeks (Q3W), for 6-8 months or intolerable toxicity). | Drug | experimental group |
Primary outcome
tumor response rate
Time frame: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
The tumor response rate will evaluate the local control of lung metastases，referring to the evaluation criteria for solid tumor efficacy RECIST 1.1
6 secondary outcomes
Minor Residual Lesions
Time frame: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
progression-free survival
Time frame: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
overall survival
Time frame: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
RTOG acute radiation injury grading
Time frame: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted during the entire SBRT process and monthly after SBRT for up to 12 months.
QLQ-30 score
Time frame: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Lymphocyte subpopulation analysis
Time frame: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
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 30 May 2024.
- Individual participant dataSharing planned: No. After the research is completed, the statistical results will be published as an article.
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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.
Xiaonan Sun, Ph D study chair
Sir Runrun Shaw Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy，SBRT and Puterizumab in people with Non-Small-Cell Lung Cancer, run by Sir Run Run Shaw Hospital.
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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaonan Sun, Ph D (8613606618387, sunxiaonan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response rate (time frame: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.). 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 30 May 2024.