CHECKMATE-816
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
71.0% male
N = 358
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 EGFR 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
20.8 months
31.6 months
23.7 months
15.8 months
7.9 months
0.0 months
Nivolumab plus
chemotherapy
Chemotherapy
alone
Significant
increase ▲
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).
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.
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