LAURA
Trial question
What is the role of osimertinib in patients with unresectable stage III EGFR-mutated non-small cell lung cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
61.0% female
39.0% male
N = 216
216 patients (132 female, 84 male).
Inclusion criteria: patients with unresectable stage III EGFR-mutated non-small cell lung cancer.
Key exclusion criteria: history of ILD before chemoradiotherapy; symptomatic pneumonitis after chemoradiotherapy; unresolved adverse effects of ≥ grade 2 after chemoradiotherapy.
Interventions
N=143 osimertinib (oral dose of 80 mg once daily).
N=73 placebo (matching placebo once daily).
Primary outcome
Median progression-free survival
39.1 months
5.6 months
39.1 months
29.3 months
19.6 months
9.8 months
0.0 months
Osimertinib
Placebo
Significant
increase ▲
Significant increase in median progression-free survival (39.1 months vs. 5.6 months; HR 6.25, 95% CI 4.17 to 10).
Secondary outcomes
No significant difference in overall survival at 36 months (84% vs. 74%; HR 1.23, 95% CI 0.64 to 2.38).
Significant increase in objective response rate (57% vs. 33%; OR 2.77, 95% CI 1.54 to 5.08).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with unresectable stage III EGFR-mutated non-small cell lung cancer, osimertinib was superior to placebo with respect to median progression-free survival.
Reference
Shun Lu, Terufumi Kato, Xiaorong Dong et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024 Aug 15;391(7):585-597.
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