Perioperative Chemoimmunotherapy Show Long-Term Benefit for Patients With Resectable Stage IIIA Non-Small Cell Lung Cancer

Updated 5-Year Results From the Phase 2 NADIM Trial 

Updated 5-year results from the phase 2 NADIM trial demonstrate that neoadjuvant chemotherapy plus nivolumab followed by surgery and adjuvant nivolumab sustained clinical benefit for patients with resectable stage IIIA non-small cell lung cancer (NSCLC). 

“Nearly 30% of individuals with NSCLC present with disease that is amenable to surgical resection, but they show poor 5-year survival,” stated Mariano Provencio, MD, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain, and coauthors. “Combining the advantages of neoadjuvant and adjuvant immunotherapy within perioperative regimens holds the potential to further enhance long-term outcomes.”

In this multicenter, single-arm study, 46 treatment-naive patients with resectable stage IIIA NSCLC received 3 cycles of paclitaxel plus carboplatin and 360 mg nivolumab followed by surgical resection and nivolumab monotherapy (240 mg for 4 months followed by 480 mg every 4 weeks for 8 months). Primary end points included 5-year progression-free survival (PFS) and overall survival (OS) in the intention-to-treat population. A key secondary end point was toxicity. 

At a median follow-up of 60 months, PFS was 65% and OS was 69.3%. Disease progression occurred in 24% of patients. Fourteen patients died, due to disease relapse (n = 9) and non-tumor-related causes (n = 5). Grade ≥3 treatment-related adverse events occurred in 30% of patients during neoadjuvant treatment and 19% of patients during adjuvant treatment. The most common events included increased lipase, febrile neutropenia, and elevated serum amylase. No treatment-related events led to surgical delay, death, or unexpected long-term toxicity. 

As Dr Provencio et al concluded these results “support the safety and long-term benefit of the perioperative chemoimmunotherapy strategy, reinforcing its use as the standard of care for patients with potentially resectable stage IIIA NSCLC.”

Source: 

Provencio M, Nadal E, Insa A, et al. Perioperative chemotherapy and nivolumab in non-small-cell lung cancer (NADIM): 5-year clinical outcomes from a multicentre, single-arm, phase 2 trial. Lancet Oncol. Published online: October 14, 2024. doi: 10.1016/S1470-2045(24)00498-4