The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are:
Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?
Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy.
Participants will:
Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.
Age ≥ 18 years. Gender is not limited.
Histologically and/or cytologically confirmed stage IV metastatic NSCLC.
Eastern Cooperative Oncology Group (ECOG) score of 0-2.
Patients who had prior first-line chemotherapy with clinical benefit lasting for ≥3 months.
Currently participating in an interventional clinical study treatment that may affect this study, or have been treated with another investigational drug or investigational device that may affect this study within 4 weeks prior to first treatment.
Pregnant or lactating women.
Progression sites deemed unsuitable for SBRT treatment as assessed by radiotherapy specialists.
Presence of untreated intracranial metastases or symptomatic progressive sites.
Parallel
Stereotactic Body Radiotherapy
RadiationThe dose of radiation therapy is determined by the radiologist based on the clinical parameters of the lesion, including tumor size and location. In most cases, radiotherapy fractionation regimens range from 27-30 Gy/3 Fractions or 30-50 Gy/5 Fractions, and appropriate radiotherapy doses covering 27-70 Gy/3-10 Fractions can also be selected by the radiologist based on radiation limitations of neighboring endangered organs.
second-line systemic therapy
Druga second-line docetaxel/albumin-bound paclitaxel-based systemic therapy regimen
progression-free survival (PFS)
Progression-free survival, PFS: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first.
Overall Survival (OS)
Overall Survival，OS: Time from date of randomization to death (from any cause).
Quality of Life (QoL)
Patient quality of life will be assessed using the patient-reported European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - Core 30 (EORTC QLQ-C-30) scale. Patient-reported EORTC-QLQ-C30 scale results will be scaled and scored according to the procedures recommended by the EORTC Quality of Life Panel, and scale scores for each visit period of the trial will be analyzed, as well as change values relative to baseline.
Safety of SBRT
the safety of SBRT
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