Phase 3 Study of Stereotactic Body Radiotherapy SBRT Combined with Standard Care Versus Standard Care Alone for Treating Oligo-Progressive Metastatic Non-Small Cell Lung Cancer After First-Line Chemotherapy

What this Trial Is About

Researchers are evaluating if Stereotactic Body Radiotherapy SBRT can improve outcomes for patients with oligo-progressive metastatic non-small cell lung cancer NSCLC after first-line chemotherapy. The study focuses on whether adding SBRT to standard care enhances progression-free survival, overall survival, and quality of life. This is a phase 3, randomized, controlled, open-label, multi-center trial for patients with stage IV NSCLC who have limited progression after initial chemotherapy benefit lasting at least 3 months. Participants are randomly assigned to receive either SBRT combined with standard care or standard care alone. SBRT targets up to five extracranial progression sites with radiation doses tailored by the radiologist based on tumor size and location. Maintenance therapy during SBRT may include immune checkpoint inhibitors ICI, bevacizumab, or single-agent chemotherapy. After progression unsuitable for SBRT, patients switch to second-line systemic therapy. The standard care group receives second-line therapy based on docetaxel or albumin-bound paclitaxel, possibly combined with immunotherapy or anti-vascular drugs. Palliative radiotherapy is allowed. During the study, participants undergo clinic visits for checkups and tests, keep symptom diaries, and complete quality of life questionnaires. Researchers monitor progression-free survival up to 18 months, overall survival up to 36 months, quality of life through survival follow-up, and safety of SBRT treatment. The study includes comprehensive examinations, imaging, blood tests, and pregnancy tests as part of screening and ongoing assessments.

Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer