FLAURA2
Trial question
What is the effect of osimertinib with chemotherapy in patients with EGFR-mutated advanced non-small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
61.0% female
39.0% male
N = 557
557 patients (342 female, 215 male).
Inclusion criteria: adult patients with EGFR-mutated advanced non-small cell lung cancer.
Key exclusion criteria: past medical history of ILD, drug-induced ILD, radiation pneumonitis that required corticosteroid treatment, or clinically active ILD; severe or uncontrolled systemic diseases; QT prolongation or any clinically important cardiac rhythm abnormalities; inadequate bone marrow reserve or organ function; prior treatment with an EGFR TKIs.
Interventions
N=279 osimertinib with chemotherapy (osimertinib 80 mg/day with pemetrexed 500 mg/m² plus either cisplatin 75 mg/m² or carboplatin).
N=278 osimertinib monotherapy (osimertinib 80 mg/day).
Primary outcome
Median progression-free survival
25.5 months
16.7 months
25.5 months
19.1 months
12.8 months
6.4 months
0.0 months
Osimertinib with
chemotherapy
Osimertinib
monotherapy
Significant
increase ▲
Significant increase in median progression-free survival (25.5 months vs. 16.7 months; HR 1.61, 95% CI 1.27 to 2.04).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with EGFR-mutated advanced non-small cell lung cancer, osimertinib with chemotherapy was superior to osimertinib monotherapy with respect to median progression-free survival.
Reference
David Planchard, Pasi A Jänne, Ying Cheng et al. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2023 Nov 23;389(21):1935-1948.
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