EP1.08-05 Local Non-Salvage Radiotherapy for Synchronous Oligometastatic NSCLC: A Multicenter, Randomized, Controlled, Phase 2 Study

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Previous studies had suggested that aggressive thoracical treatment, such as surgery, might lead to higher local control rate and better long-term survival in oligometastatic NSCLC. Radiotherapy (RT) is also an effective and less invasive local treatment. Therefore, we assessed the role of addition of aggressive thoracical RT to first-line systemic therapy in patients with synchronous oligometastatic NSCLC. Stage IV patients with measurable primary tumor and distant metastases number ≤5, histologically or cytologically confirmed NSCLC and ECOG PS≤2 were included. All enrolled patients had not previously experienced local or systemic antitumor treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy. Other inclusion criteria included adequate organ function and life expectancy of >3 months. Our study randomized patients at 1:1 ratio to receive systemic therapy plus radiotherapy(RT+) or systemic therapy alone(RT-). First-line regimens recommended by NCCN guidelines are allowed for systemic therapy, including standard platinum-based doublet chemotherapy, targeted therapy, antiangiogenic therapy and immunotherapy. Three-dimensional conformal radiotherapy(3D-CRT) or Intensity modulated radiotherapy(IMRT) to primary thoracic foci or remediable oligometastatic focus should be given no later than disease progression. Randomization was stratified by histological type (squamous cell carcinoma vs. adenocarcinoma), first-line systemic therapy (targeted therapy vs. non-targeted therapy), intracranial metastasis (yes vs. no), number of metastases (1 vs. 2-5) and local stage (I/II vs. III). Primary endpoint of this study is progression-free survival(PFS) based on RECIST v. 1.1 criteria. Secondary endpoint are local tumor control; oligometastatic foci control; thoracic progression-free survival(TPFS); overall survival(OS); toxicity and compliance. The study has 80% power to detect a greater effect of RT+ group in PFS at a 2-sided alpha level of 0.05. Assuming a 10% drop-out rate, randomization of 148 patients was planned. The trial opened in China in November 2017. To date, 14 patients have been randomized and 2 sites in China have activated the trial. Support: 81572279, 2016J004, LC2016PY016, 2018CR033. Clinical trial information: NCT03119519. Section not applicable Section not applicable