- 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.
- 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.
- 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.
- Higher than previously reported mortality rate.