6/28/23, 12:08 AM CHECKMATE-816 Pathway Feedback Search Clinical Topics Home Studies CHECKMATE 816 CHECKMATE 816 Disease Non-small cell lung cancer Trial question What is the role of neoadjuvant nivolumab plus chemotherapy in patients with resectable non- small cell lung cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 29.0% female N = 358 71.0% male 358 patients (103 female, 255 male) Inclusion criteria: patients with stage IB to IIIA resectable non-small cell lung cancer Key exclusion criteria: known ALK translocations or epidermal growth factor receptor mutations; locally advanced, inoperable or metastatic disease; active, known or suspected autoimmune disease Interventions N=179 nivolumab plus chemotherapy (nivolumab 360 mg plus platinum-doublet chemotherapy, followed by resection) N=179 chemotherapy alone (platinum-doublet chemotherapy alone, followed by resection) Primary outcome Event-free survival 31.6 months 31.6 https://web.pathway.md/studies/recF0uB1mOG2Mx2wE 1/2 6/28/23, 12:08 AM CHECKMATE-816 Pathway 23.7 months 20.8 15.8 months 7.9 months Significant increase 0.0 months Nivolumab plus chemotherapy Chemotherapy alone Significant increase in event-free survival (31.6 months vs. 20.8 months; AD 10.8 months, 95% CI 3.27 to 18.33) Secondary outcomes Significant increase in pathological complete response (24% vs. 2.2%; AD 21.8%, 95% CI 15.2 to 28.7) Borderline significant increase in major pathological response (36.9% vs. 8.9%; OR 5.7, 95% CI 3.16 to 10.26) Safety outcomes No significant differences in adverse events, grade 3 or 4 treatment-related adverse events. Conclusion In patients with stage IB to IIIA resectable non-small cell lung cancer, nivolumab plus chemotherapy was superior to chemotherapy alone with respect to a event-free survival. Reference Patrick M Forde, Jonathan Spicer, Shun Lu et al. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Open reference URL https://web.pathway.md/studies/recF0uB1mOG2Mx2wE 2/2