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Trial Title:
A Study of SBRT Combined With Puterizumab in Intrapulmonary Metastasis From NSCLC
NCT ID:
NCT06434740
Condition:
Non-Small-Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
lung cancer
radiotherapy
immunotherapy
single-cell sequencing
SBRT
peripheral blood mononuclear cell
minimalResidual disease
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy，SBRT
Description:
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.
Arm group label:
experimental group
Intervention type:
Drug
Intervention name:
Puterizumab
Description:
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).
Arm group label:
experimental group
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. age≥18
2. Non small cell lung cancer patients who have experienced pulmonary metastasis after
PD-1 immunotherapy in the past
3. Voluntarily participate in this study and sign an informed consent form
4. The presence of evaluable size and number of pulmonary metastases on chest CT
5. There are indications for lung puncture biopsy
6. General physical condition (ECOG) 0-1
7. 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.
Exclusion Criteria:
1. Unable to tolerate or refuse further immunotherapy
2. Vulnerable groups, including individuals with mental illness, cognitive impairment,
critically ill patients, minors, pregnant women, illiteracy, etc
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Sir Run Run Shaw Hospital
Agency class:
Other
Source:
Sir Run Run Shaw Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434740
