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

NCT06434740 | Not Yet Recruiting Phase 2

• 1 other identifier: SRRS-LCsbrt
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Small-Cell Lung Cancer

Keywords

lung cancer; radiotherapy; immunotherapy; single-cell sequencing; SBRT; peripheral blood mononuclear cell; minimalResidual disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• 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.

Study Arms (1)

experimental group

EXPERIMENTAL

The enrolled subjects will receive SBRT treatment combined with Puterizumab.

Radiation: Stereotactic Body Radiation Therapy，SBRT; Drug: Puterizumab

Interventions

Stereotactic Body Radiation Therapy，SBRT RADIATION

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.

experimental group

Puterizumab DRUG

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).

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaonan Sun, Ph D

  Sir Runrun Shaw Hospital

  STUDY CHAIR

Central Study Contacts

Xiaonan Sun, Ph D

CONTACT

8613606618387; sunxiaonan@zju.edu.cn

Xuyun Xie, MD

CONTACT

8613989882983; 3413007@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share