Stereotactic Body Radiotherapy (SBRT) for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer (OPPRESS):A Randomized, Controlled, Open-label, Multi-Center Phase 3 Study
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.
• Driver gene-negative NSCLC patients with oligo-progression during first-line chemotherapy combined with Immune Checkpoint Inhibitors (ICI). Driver gene-positive NSCLC patients, such as epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion positivity, are allowed to enroll if oligo-progression occurred during treatment with first-line chemotherapy combined with bevacizumab ± ICI after failure of Tyrosine Kinase Inhibitor (TKI) therapy.
• Progressive sites were assessed as ≤5 according to RECIST v1.1 criteria combined with positron emission tomography / computertomography (PET/CT), and all were located extracranially. Progressive lymph node lesions are counted by region, with each lymph node region amenable to concurrent SBRT (which may contain multiple progressive lymph nodes) counted as 1 progressive site.
• All progressive sites should be visible on radiologic imaging and assessed as suitable for SBRT treatment by a radiotherapist.
• Intracranial progressive lesions and symptomatic lesions can be treated with palliative radiotherapy and local therapy prior to enrollment and are not counted within the oligo-progressive sites.
• Expected survival time greater than 3 months.
• Comprehensive examination completed within 28 days prior to enrollment in the study and a complete blood count/differential, collected within 15 days, showing that the patient has normal internal organ function and normal bone marrow function.
• Negative serum or urine pregnancy test in females of childbearing age within 14 days prior to study enrollment.
• Patients are willing to provide written informed consent and must be willing to adhere to the prescribed follow-up schedule.