Randomized phase 2 trial of stereotactic ablative radiotherapy with or without immunootherapy for early-stage non-small cell lung cancer

Stereotactic ablative radiotherapy (SABR) is the standard treatment for medically inoperable early-stage non-small cell lung cancer (NSCLC), but regional or distant relapses, or both, are common. Immunotherapy reduces recurrence and improves survival in patients with stage III NSCLC after chemoradiotherapy, but its utility in stage I and II cases is unclear. A randomized phase 2 trial at three centers in Texas compared SABR alone versus SABR with immunotherapy (I-SABR) for people with early-stage or isolated parenchymal recurrences (tumor size ≤ 7 cm) node-negative NSCLC. The study found that compared with SABR alone, I-SABR significantly improved event-free survival (A: per-protocol population; B: ITT population) with tolerable toxicity. The authors conclude that I-SABR could be a treatment option in these patients, although further confirmation from a number of currently recruiting phase 3 trials is required.