ADAURA
Trial question
What is the role of adjuvant osimertinib therapy in patients with completely resected, EGFR-mutated, stage IB-IIIA non-small cell lung cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
70.0% female
30.0% male
N = 682
682 patients (477 female, 205 male)
Inclusion criteria: adult patients with postsurgical stage IB, II, or IIIA non-small cell lung cancer who had centrally confirmed EGFR mutation
Key exclusion criteria: prior anticancer therapy; history of other malignancies; major surgery within 4 weeks of the first dose of study drug; severe or uncontrolled systemic diseases
Interventions
N=339 osimertinib (at an oral dose of 80 mg once daily)
N=343 placebo (matching placebo once daily)
Primary outcome
Overall survival at 5 years, among patients with stage II to IIIA disease
85
73
85.0 %
63.8 %
42.5 %
21.3 %
0.0 %
Osimertinib
Placebo
Significant increase ▲
NNT = 8
Significant increase in overall survival at 5 years, among patients with stage II to IIIA disease (85% vs. 73%; AD 12%, 95% CI 4.88 to 19.12)
Secondary outcomes
Significant increase in overall survival at 5 years, among patients with stage IB to IIIA disease (88% vs. 78%; AD 10%, 95% CI 4.07 to 15.93)
Safety outcomes
No significant difference in adverse events and serious adverse events.
Conclusion
In adult patients with postsurgical stage IB, II, or IIIA non-small cell lung cancer who had centrally confirmed EGFR mutation, osimertinib was superior to placebo with respect to overall survival at 5 years, among patients with stage II to IIIA disease.
Reference
Masahiro Tsuboi, Roy S Herbst, Thomas John et al. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023 Jul 13;389(2):137-147.
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