Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer
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-smal
| Condition(s) | Metastatic Non-Small Cell Lung Cancer, NSCLC Stage IV, OligoProgressive Metastatic Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2024-09 |
| NCT ID | NCT06523673 |
| Official listing | https://clinicaltrials.gov/study/NCT06523673 |