Top Line: Adjuvant immunotherapy after chemoradiation improves overall survival for patients with stage III NSCLC.
The Study: Could the addition of immunotherapy concurrent with chemoradiation further improve outcomes? The phase 2 NICOLAS trial sought to detect a possible improvement in progression-free survival by combining nivolumab with concurrent chemoradiation among 79 patients with stage IIIA/B NSCLC. Patients received concurrent cisplatin-based chemo and radiation (66 Gy in 33 fractions), and nivolumab was given during chemoradiation and then continued for a year after completion of therapy. The study was designed to show an improvement in 1-year PFS from 45→ 60% compared to historical control. As a reference, 1-year PFS in the landmark PACIFIC trial was 55.9%. At 1 year, the PFS rate was 53.7%. This seems comparable to PACIFIC outcomes, but statistically speaking, the authors could not demonstrate a significant improvement in 1-year PFS with concurrent and adjuvant nivolumab. There are several other ongoing trials (including randomized phase 3 trials) testing whether concurrent radioimmunotherapy further improves treatment outcomes over chemoradiation and maintenance immunotherapy.
TBL: More data is necessary before combining immunotherapy (concurrently) with chemoradiation for stage III NSCLC. | Peters, J Thorac Oncol 2020