6/28/23, 10:39 PM FLAURA Pathway Feedback Search Clinical Topics Home Studies FLAURA FLAURA Disease Non-small cell lung cancer Trial question What is the role of osimertinib in untreated epidermal growth factor receptor-mutation-positive advanced non-small cell lung cancer? Study design Multi-center Double blinded RCT Population Characteristics of study participants 63.0% female N = 556 37.0% male 556 patients (350 female, 206 male) Inclusion criteria: patients with untreated epidermal growth factor receptor-mutation-positive advanced non-small cell lung cancer Key exclusion criteria: prior treatment with any systemic anti-cancer therapy for locally advanced/metastatic non-small cell lung cancer; alternative anti-cancer treatment; major surgery within 4 weeks of the first dose of study drug Interventions N=279 osimertinib (at a dose of 80 mg once daily) N=277 standard EGFR-TKI (gefitinib 250 mg once daily or erlotinib 150 mg once daily) Primary outcome Progression-free survival 18.9 months 18.9 https://web.pathway.md/studies/recwxfSaPLYpC8zm0 1/2 6/28/23, 10:39 PM FLAURA Pathway 14.2 months 10.2 9.4 months 4.7 months Significant increase 0.0 months Osimertinib Standard EGFR-TKI Significant increase in progression-free survival (18.9 months vs. 10.2 months; AD 8.7 months, 95% CI 3.54 to 13.86) Secondary outcomes No significant difference in objective response rate (80% vs. 76%; OR 1.27, 95% CI 0.85 to 1.9) Significant increase in survival rate at 18 months (83% vs. 71%; AD 12%, 95% CI 3.28 to 20.72) Safety outcomes No significant difference in adverse events and serious adverse events. Conclusion In patients with untreated epidermal growth factor receptor-mutation-positive advanced non- small cell lung cancer, osimertinib was superior to standard EGFR-TKI with respect to a progression-free survival. Reference Jean-Charles Soria, Yuichiro Ohe, Johan Vansteenkiste et al. Osimertinib in Untreated EGFR- Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. Open reference URL https://web.pathway.md/studies/recwxfSaPLYpC8zm0 2/2