Interim results from the phase III NADIM ADJUVANT trial, led by the Spanish Lung Cancer Group, suggest that adjuvant chemoimmunotherapy 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 (Abstract PL03.07). The study, presented 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 chemoimmunotherapy in the adjuvant setting, building on perioperative evidence from the earlier NADIM and NADIM II studies.
Results From NADIM ADJUVANT
Between January 2021 and December 2022, 206 patients from 30 hospitals across Spain were randomly assigned 1:1 to receive either adjuvant chemotherapy (carboplatin at AUC = 5 plus paclitaxel at 200 mg/m² every 3 weeks for four cycles) followed by observation (control arm) or the same chemotherapy plus nivolumab at 360 mg every 3 weeks for four cycles, followed by maintenance nivolumab at 480 mg every 4 weeks for six cycles (experimental arm). The primary endpoint was disease-free survival; secondary endpoints included overall survival and safety. Measurable residual disease (MRD) was assessed using circulating tumor DNA (Guardant Reveal).
Presenting author Mariano Provencio, MD, PhD, of the Hospital Universitario Puerta de Hierro Majadahonda, reported that median disease-free survival was not reached in either arm after a median follow-up of 34 months; the disease-free survival first quartile was 31.0 months (experimental arm) vs 17.0 months (control arm). The 3-year relapse rate was 26.7% (experimental arm) vs 40.1% (control arm).
Dr. Provencio also reported that postoperative MRD was associated with significantly worse disease-free survival in the experimental arm (hazard ratio = 5.7, P = .045). The rate of grade ≥ 3 treatment-related adverse events was 26.2% (experimental arm) vs 14.5% (control arm) during the 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 Dr. Provencio. “Further follow-up will be essential to confirm long-term efficacy.”
Disclosure: For full disclosures of the study authors, visit cattendee.abstractsonline.com.
