ADRIATIC
Trial question
What is the role of adjuvant therapy with durvalumab in patients with limited-stage small cell lung cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 530
530 patients (164 female, 366 male).
Inclusion criteria: patients with limited-stage small cell lung cancer without disease progression after standard concurrent platinum-based chemoradiotherapy.
Key exclusion criteria: history of ≥ grade 2 pneumonitis from previous chemoradiotherapy; extensive-stage small cell lung cancer; uncontrolled intercurrent illness; active infection; active or prior documented autoimmune or inflammatory disorder; receipt of sequential chemotherapy and radiotherapy.
Interventions
N=264 durvalumab (at a dose of 1,500 mg every 4 weeks for up to 24 months).
N=266 placebo (matching placebo every 4 weeks for up to 24 months).
Primary outcome
Median overall survival
55.9 months
33.4 months
55.9 months
41.9 months
27.9 months
14.0 months
0.0 months
Durvalumab
Placebo
Significant
increase ▲
Significant increase in median overall survival (55.9 months vs. 33.4 months; HR 1.37, 97.5% CI 1.02 to 1.85).
Secondary outcomes
Significant increase in median progression-free survival (16.6 months vs. 9.2 months; HR 1.32, 97.5% CI 1.02 to 1.69).
Safety outcomes
No significant difference in adverse events of grade 3-4.
Conclusion
In patients with limited-stage small cell lung cancer without disease progression after standard concurrent platinum-based chemoradiotherapy, durvalumab was superior to placebo with respect to median overall survival.
Reference
Ying Cheng, David R Spigel, Byoung Chul Cho et al. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024 Oct 10;391(14):1313-1327.
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