New Study Highlights Benefits of Adjuvant Chemo-Immunotherapy in Resected Stage IB–IIIA Non-Small Cell Lung Cancer

Recent interim findings from the NADIM ADJUVANT Phase III clinical trial, conducted by the Spanish Lung Cancer Group (GECP), suggest that incorporating chemo-immunotherapy after surgical resection may significantly decrease the risk of cancer recurrence in patients with stage IB through IIIA non-small cell lung cancer (NSCLC). The study indicates that this approach maintains an acceptable safety profile, offering hope for improved management of early-stage NSCLC.

Despite successful complete tumor removal (R0 resection), early-stage NSCLC patients face a high likelihood of disease recurrence, contributing to substantial cancer-related mortality. This trial, presented at the 2025 World Conference on Lung Cancer organized by the International Association for the Study of Lung Cancer (IASLC), is the first phase III randomized trial to evaluate the efficacy of adjuvant chemo-immunotherapy in this setting, building upon previous perioperative research from NADIM and NADIM II studies.

The trial enrolled 206 patients from 30 Spanish hospitals between January 2021 and December 2022. Participants were randomized equally into two groups: one received standard chemotherapy (carboplatin AUC5 with paclitaxel 200 mg/m² over four cycles), followed by observation; the other received the same chemotherapy combined with nivolumab, a PD-1 inhibitor, administered every three weeks during the four cycles, then as maintenance therapy every four weeks for six additional cycles.

The primary goal was to assess disease-free survival (DFS), with overall survival (OS) and safety as secondary endpoints. Additionally, circulating tumor DNA was used to evaluate minimal residual disease (MRD). After a median follow-up of 34 months, results showed that median DFS was not reached in either group. However, the first quartile of DFS was longer in the chemo-immunotherapy group at approximately 31 months compared to 17 months in the control group. The three-year relapse rate was 26.7% in the chemo-immunotherapy arm versus 40.1% in the control, indicating a potential benefit.

Postoperative MRD status appeared to influence outcomes, with MRD positivity correlating with significantly worse DFS, especially in the experimental group (hazard ratio of 5.7). Although the addition of nivolumab led to better disease control, it was associated with higher rates of grade 3 or higher adverse events during treatment, affecting about 26.2% of patients compared to 14.5% in the control group.

"The interim data from NADIM ADJUVANT suggest that adding nivolumab to adjuvant chemotherapy can help lower recurrence risk and provide meaningful clinical benefits for patients after surgery," stated lead investigator Dr. Mariano Provencio. "Further follow-up is necessary to confirm the sustainability of these results and the long-term impact on survival."

These promising findings point towards a potential shift in the standard care for early-stage NSCLC, emphasizing the importance of integrating immunotherapy into surgical treatment strategies. Source: https://medicalxpress.com/news/2025-09-clinical-trial-benefit-adjuvant-chemo.html