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.
- 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.
- 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.
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.