CRT with nivolumab passes safety test in stage III NSCLC

  • Lung Cancer

  • curated by Emily Willingham, PhD
  • Univadis Clinical Summaries
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Takeaway

  • For stage III NSCLC, chemoradiotherapy (CRT) with nivolumab as combined first-line regimen yielded no unexpected safety signals in the NICOLAS trial .
  • 1-year PFS remains to be determined.

Why this matters

  • The combination of CRT and immunotherapy has proved promising in preclinical investigations.
  • The NICOLAS trial is intended to resolve the question of whether concurrent immunotherapy and CRT increases lung toxicity. 
  • Large trials of the combination are starting up.  

Key results

  • Median follow-up at publication was 13.4 months.
  • Most frequent adverse events (AEs): anemia, fatigue, pneumonitis.
  • The combination yielded no increase in AEs or toxicities.
  • No grade 3 or more pneumonitis observed at 3 months following RT.
  • Interim safety analysis suggests safety, tolerability of the CRT-immunotherapy combination.

Study design

  • 82 included patients (2 died) received 3 cycles of platinum-based chemotherapy with concurrent radiotherapy (66 Gy/33 fractions), with nivolumab starting with the radiotherapy.
  • Interim analysis, 3-month rate of grade ≥3 pneumonitis.
  • Funding: European Thoracic Oncology Platform; Bristol-Myers Squibb.

Limitations

  • Higher than previously reported mortality rate.