Clinical trial

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

Name

SRRS-LCsbrt

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2026-12-30

Trial end

2027-12-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

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.

Arms:

experimental group

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).

Arms:

experimental group

Size

Primary endpoint

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.

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ESTIMATED'}}

Updated at

2024-05-30

1 organization

1 product

1 indication

Organization

Sir Run Run Shaw Hospital

Product

Puterizumab

Indication

Lung Cancer