(Barcelona, Spain September 8, 2025, 10:45 a.m. CEST / UTC +2) – Interim results from the NADIM ADJUVANT Phase III trial, led by the Spanish Lung Cancer Group (GECP), suggest that adjuvant chemo-immunotherapy may reduce the risk of recurrence in patients with completely resected stage IB–IIIA non-small cell lung cancer (NSCLC) while maintaining an acceptable safety profile.
Despite complete surgical resection (R0), early-stage NSCLC carries a substantial risk of recurrence and remains a leading cause of cancer-related mortality.
The study, presented today at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC), is the first randomized Phase III trial to examine chemo-immunotherapy in the adjuvant setting, building on perioperative evidence from the earlier NADIM and NADIM II studies.
Between January 2021 and December 2022, 206 patients from 30 hospitals across Spain were randomized 1:1 to receive either adjuvant chemotherapy (carboplatin AUC5 plus paclitaxel 200 mg/m² every 3 weeks for 4 cycles) followed by observation (control arm) or the same chemotherapy plus nivolumab 360 mg every 3 weeks for 4 cycles, followed by maintenance nivolumab 480 mg every 4 weeks for 6 cycles (experimental arm). The primary endpoint was disease-free survival (DFS); secondary endpoints included overall survival (OS) and safety. Minimal residual disease (MRD) was assessed using circulating tumor DNA (Guardant Reveal).
Mariano Provencio, MD, PhD, Hospital Universitario Puerta de Hierro Majadahonda, reported that median DFS was not reached in either arm after a median follow-up of 34 months and the DFS first quartile was 30.98 months (experimental) vs. 17.01 months (control). The three-year relapse rate was 26.7% (experimental) vs. 40.1% (control).
Dr. Provencio also reported that the postoperative MRD associated with significantly worse DFS in the experimental arm (HR = 5.7, p = 0.045) and grade ≥3 treatment-related adverse events: 26.2% (experimental) vs. 14.5% (control) during adjuvant phase.
"The interim results of NADIM ADJUVANT suggest that adding nivolumab to adjuvant chemotherapy can reduce recurrence risk and may offer meaningful clinical benefit for patients with completely resected stage IB–IIIA NSCLC," said Mariano Provencio, MD, PhD, Hospital Universitario Puerta de Hierro Majadahonda. "Further follow-up will be essential to confirm long-term efficacy."
