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

Phase 2

Not yet recruiting

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy，SBRT; Drug: Puterizumab

• Registration Number: NCT06434740
• Lead Sponsor: Sir Run Run Shaw Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-19
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Start: 2024-06-01
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Stereotactic Body Radiation Therapy，SBRT	The enrolled subjects will receive SBRT treatment combined with Puterizumab.
experimental group	Puterizumab	The enrolled subjects will receive SBRT treatment combined with Puterizumab.

Primary Outcome Measures

Name	Time	Method
tumor response rate	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 Outcome Measures

Name	Time	Method
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.	OS is the time from enrollment to death due to any reason.
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.	Refer to the acute radiation injury grading standards of the United States Collaborative Group on Tumor Radiotherapy (RTOG)
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.	The quality of life will be evaluated using the QLQ-30 score.
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.	Using flow cytometry to detect the count and percentage of lymphocytes, including CD3+, CD3+, CD4+, CD3+, CD8+, CD4+/CD8+, and CD3-CD56+.
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.	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.
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.	PFS is the time from enrollment to tumor progression or death.