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

NCT ID: NCT06434740

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

The enrolled subjects will receive SBRT treatment combined with Puterizumab.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy，SBRT

Intervention Type: 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.

Puterizumab

Intervention Type: 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).

Interventions

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.

Intervention Type: RADIATION

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaonan Sun, Ph D

Role: STUDY_CHAIR

Sir Runrun Shaw Hospital

Central Contacts

Xiaonan Sun, Ph D

Role: CONTACT

sunxiaonan@zju.edu.cn

8613606618387

Xuyun Xie, MD

Role: CONTACT

3413007@zju.edu.cn

8613989882983

Other Identifiers

SRRS-LCsbrt

Identifier Type: -

Identifier Source: org_study_id