Interim results from nan NADIM ADJUVANT Phase III trial, led by nan Spanish Lung Cancer Group (GECP), propose that adjuvant chemo-immunotherapy whitethorn trim nan consequence of recurrence successful patients pinch wholly resected shape IB–IIIA non-small compartment lung crab (NSCLC) while maintaining an acceptable information profile.
Despite complete surgical resection (R0), early-stage NSCLC carries a important consequence of recurrence and remains a starring origin of cancer-related mortality.
The study, presented coming astatine nan International Association for nan Study of Lung Cancer (IASLC) 2025 World Conference connected Lung Cancer (WCLC), is nan first randomized Phase III proceedings to analyse chemo-immunotherapy successful nan adjuvant setting, building connected perioperative grounds from nan earlier NADIM and NADIM II studies.
Between January 2021 and December 2022, 206 patients from 30 hospitals crossed Spain were randomized 1:1 to person either adjuvant chemotherapy (carboplatin AUC5 positive paclitaxel 200 mg/m² each 3 weeks for 4 cycles) followed by study (control arm) aliases nan aforesaid chemotherapy positive nivolumab 360 mg each 3 weeks for 4 cycles, followed by attraction nivolumab 480 mg each 4 weeks for 6 cycles (experimental arm). The superior endpoint was disease-free endurance (DFS); secondary endpoints included wide endurance (OS) and safety. Minimal residual illness (MRD) was assessed utilizing circulating tumor DNA (Guardant Reveal).
Mariano Provencio, MD, PhD, Hospital Universitario Puerta de Hierro Majadahonda, reported that median DFS was not reached successful either limb aft a median follow-up of 34 months and nan DFS first quartile was 30.98 months (experimental) vs. 17.01 months (control). The three-year relapse complaint was 26.7% (experimental) vs. 40.1% (control).
Dr. Provencio besides reported that nan postoperative MRD associated pinch importantly worse DFS successful nan experimental limb (HR = 5.7, p = 0.045) and people ≥3 treatment-related adverse events: 26.2% (experimental) vs. 14.5% (control) during adjuvant phase.
The interim results of NADIM ADJUVANT propose that adding nivolumab to adjuvant chemotherapy tin trim recurrence consequence and whitethorn connection meaningful objective use for patients pinch wholly resected shape IB–IIIA NSCLC. Further follow-up will beryllium basal to corroborate semipermanent efficacy."
Mariano Provencio, MD, PhD, Hospital Universitario Puerta de Hierro Majadahonda