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

Sir Run Run Shaw Hospital0 sites37 target enrollmentJune 1, 2024

ConditionsNon-Small-Cell Lung Cancer

InterventionsStereotactic Body Radiation Therapy，SBRT Puterizumab

Overview

Phase: Phase 2
Intervention: Stereotactic Body Radiation Therapy，SBRT
Conditions: Non-Small-Cell Lung Cancer
Sponsor: Sir Run Run Shaw Hospital
Enrollment: 37
Primary Endpoint: tumor response rate
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 1, 2024

End Date

December 30, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sir Run Run Shaw Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Arms & Interventions

experimental group

The enrolled subjects will receive SBRT treatment combined with Puterizumab.

Intervention: Stereotactic Body Radiation Therapy，SBRT

experimental group

The enrolled subjects will receive SBRT treatment combined with Puterizumab.

Intervention: Puterizumab

Outcomes

Primary Outcomes

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

Secondary Outcomes

overall survival(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(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(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(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.)
Minor Residual Lesions(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(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.)