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The New England Journal of MedicinePerioperative Nivolumab and Chemotherapy in Stage III Non–Small-Cell Lung Cancer

An open-label, phase 2 clinical trial.

In the ongoing pursuit of effective treatment for stage III non-small-cell lung cancer (NSCLC), a phase 2 trial has explored the combination of perioperative nivolumab and platinum-based chemotherapy. This study aimed to evaluate the efficacy and safety of this combination compared to chemotherapy alone, focusing on pathological complete response, progression-free survival, and overall survival at 24 months.

Study Design:

  • Participants: 86 patients with resectable stage IIIA or IIIB NSCLC.
  • Methods: Randomized assignment to receive neoadjuvant nivolumab plus platinum-based chemotherapy (experimental group) or chemotherapy alone (control group), followed by surgery. Adjuvant treatment with nivolumab for 6 months in the experimental group if R0 resections were achieved.
  • Primary End Point: Pathological complete response (0% viable tumor in resected lung and lymph nodes).
  • Secondary End Points: Progression-free survival and overall survival at 24 months, safety.

Key Findings:

  • Pathological complete response in 37% of experimental group vs. 7% in control group (P=0.02).
  • Surgery performed in 93% of experimental group vs. 69% in control group.
  • Progression-free survival at 24 months: 67.2% in experimental group vs. 40.9% in control group.
  • Overall survival at 24 months: 85.0% in experimental group vs. 63.6% in control group.
  • Grade 3 or 4 adverse events in 19% of experimental group and 10% of control group.


  • Perioperative treatment with nivolumab plus chemotherapy led to a higher percentage of pathological complete response and longer survival than chemotherapy alone in patients with resectable stage IIIA or IIIB NSCLC.

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Did You Know?
Approximately 20% of patients diagnosed with non-small-cell lung cancer are found to have stage III disease, highlighting the importance of effective treatment strategies for this stage.

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