WCLC 2025 | START-NEW-ERA: chemo-SABR & immunotherapy in unresectable LA-NSCLC

It was a pleasure for me to present for the first time the preliminary outcomes of our trial, evaluating the feasibility and efficacy of immunotherapy after sequential chemotherapy and SBRT. Two days ago I presented our results. Our patients are enrolled in the START-NEW-ERA trial, phase two trial, not a randomized trial, and I focused our presentation on the subgroup of patients having a PD-L1 greater than or equal to 1%, who received, we did one month after the end of SBRT immunotherapy. Patients received neoadjuvant chemotherapy followed by SBRT and immunotherapy. Until now, we enrolled 35 patients and the majority of patients were former smokers, had adenocarcinoma, a stage 3 disease, a resectable stage 3 disease and multiple lymph node involvement. Our trial enrolled patients unfit for concurrent chemo radiotherapy so they are a frailer population and in this setting of patient we have a lack of data regarding the efficacy of SBRT in respect to or compared to early stage non-small cell lung cancer. We obtained optimal local control with a recurrence local recurrence-free survival very high at three years in fact it was 71% and good thoracic nodal recurrence-free survival. In fact, at three years, the majority of patients were without local disease and a median progression-free survival of 34 months and a median overall survival of 72 months at a median follow-up of 36 months. So we concluded that in this setting of patients who represent a frailer population, our combination of treatment, chemotherapy, SBRT and IO is an opportunity. We administered higher doses in a few days and our technique was a VMAT technique administering doses in five daily fractions. The median doses administered were 50 gray in 5 daily fractions on primary tumor and 40 gray in 5 daily fractions on lymph nodes. Our is a very complicated technique, but using a simultaneous integrated boost and simultaneous integrated protection it’s possible to differentiate the dose on T and N and to lower the doses to the part of PTV closest to the organ at risk. So it’s possible to treat better the tumor respecting the organ at risk. In fact, we don’t have relevant toxicity. Only 9% of patients discontinued immunotherapy after SBRT and only grade 3 acute toxicity was SBRT related. So we think that this could be a strategy we have to investigate in a phase 3 trial.

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