Menu
Not yet recruiting NCT06434740

A Study of SBRT Combined With Puterizumab in Intrapulmonary Metastasis From NSCLC

Phase II Interventional Non-Small-Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic Body Radiation Therapy，SBRT, Puterizumab.
Who it may be relevant to
Registry conditions: Non-Small-Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Radiation Stereotactic Body Radiation Therapy，SBRT
    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.
  • Drug Puterizumab
    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).

Primary outcome measures

  • 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.]
Secondary outcome measures (6)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Unable to tolerate or refuse further immunotherapy
  • Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06434740 · SRRS-LCsbrt

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗