Clinical trial · Interventional
A Study of SBRT Combined With Puterizumab in Intrapulmonary Metastasis From NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Puterizumab | Drug | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy，SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- The enrolled subjects will receive SBRT treatment combined with Puterizumab.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy，SBRT
- Drug: Puterizumab
Primary outcomes (1)
- measure
- tumor response rate
- timeFrame
- 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.
- description
- 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 outcomes (6)
- measure
- Minor Residual Lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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