Nivolumab plus chemoradiotherapy followed by nivolumab with or without ipilimumab for untreated locally advanced stage III NSCLC: a randomized phase 3 trial - Summary - MDSpire

Nivolumab plus chemoradiotherapy followed by nivolumab with or without ipilimumab for untreated locally advanced stage III NSCLC: a randomized phase 3 trial

  • By

  • Solange Peters

  • Daniel S. W. Tan

  • David E. Gerber

  • James Urbanic

  • Suresh Ramalingam

  • Jinming Yu

  • Ligang Xing

  • Achim Rittmeyer

  • Tudor-Eliade Ciuleanu

  • Juliana de Menezes

  • Hye Ryun Kim

  • Carlos Rojas

  • Konstantinos Syrigos

  • Hidetoshi Hayashi

  • Anoop Haridass

  • Diego Cortinovis

  • Debora Bruno

  • Martin Kimmich

  • Antonio Calles

  • Raheel Nathani

  • Geetha Pudussery

  • Luoying Yang

  • Dirk De Ruysscher

  • May 13, 2026

  • 0 min

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Objective:

To evaluate the efficacy and safety of nivolumab plus ipilimumab or nivolumab alone following concurrent chemoradiotherapy (CCRT) compared to the standard of care, durvalumab, in treatment-naive patients with locally advanced stage III NSCLC.

Key Findings:
  • No significant difference in progression-free survival (PFS) between nivolumab plus ipilimumab (16.7 months) and durvalumab (15.6 months; HR: 0.95), indicating similar efficacy.
  • Numerical improvement in PFS for nivolumab plus ipilimumab in patients with tumor PDL1 expression ≥50% (25.5 months vs 19.4 months), suggesting a potential benefit in this subgroup.
  • Median overall survival (OS) was 34.6 months for nivolumab plus ipilimumab and 40.2 months for durvalumab (HR: 1.12), highlighting the need for further investigation.
Interpretation:

The addition of ipilimumab to nivolumab did not significantly improve PFS compared to durvalumab in the overall population, although there was a potential benefit in a specific subgroup with high PDL1 expression, warranting further exploration.

Limitations:
  • The primary endpoint of PFS did not reach statistical significance, limiting the interpretation of OS results and the overall efficacy of the treatment.
  • Discontinuation rates due to disease progression and treatment-related adverse events were notable, which may affect the generalizability of the findings.
Conclusion:

The study did not demonstrate a significant advantage of nivolumab plus ipilimumab over durvalumab in terms of PFS or OS in the overall population, highlighting the need for further research to explore potential benefits in specific subgroups.

Original Source(s)

Nivolumab plus chemoradiotherapy followed by nivolumab with or without ipilimumab for untreated locally advanced stage III NSCLC: a randomized phase 3 trial

  • by Solange Peters, Daniel S. W. Tan, David E. Gerber, James Urbanic, Suresh Ramalingam, Jinming Yu, Ligang Xing, Achim Rittmeyer, Tudor-Eliade Ciuleanu, Juliana de Menezes, Hye Ryun Kim, Carlos Rojas, Konstantinos Syrigos, Hidetoshi Hayashi, Anoop Haridass, Diego Cortinovis, Debora Bruno, Martin Kimmich, Antonio Calles, Raheel Nathani, Geetha Pudussery, Luoying Yang, Dirk De Ruysscher

  • May 13, 2026

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