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

Non-Small-Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434740
• Other study ID #: SRRS-LCsbrt
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: May 2024
• Source: Sir Run Run Shaw Hospital
• Contact: Xiaonan Sun, Ph D
• Phone: 8613606618387
• Email: sunxiaonan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	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	progression-free survival	PFS is the time from enrollment to tumor progression or death.	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	overall survival	OS is the time from enrollment to death due to any reason.	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	RTOG acute radiation injury grading	Refer to the acute radiation injury grading standards of the United States Collaborative Group on Tumor Radiotherapy (RTOG)	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.
Secondary	QLQ-30 score	The quality of life will be evaluated using the 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.
Secondary	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+.	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.