FLAURA
In untreated advanced EGFR-mutated NSCLC, does osimertinib improve outcomes compared with gefitinib or erlotinib?
Trial design and population
Key results
Median PFS was 18.9 vs 10.2 months (HR 0.46, 95% CI 0.37–0.57; P<.001). Final median OS was 38.6 vs 31.8 months (HR 0.80, 95.05% CI 0.64–1.00; P=.046).
Source-reported outcome visualization
Median overall survival · Median
Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.
Absolute Effect
Median OS difference 6.8 months is not an NNT; median survival differences cannot be converted directly into NNT.
NNT: Not calculated; median OS difference is not a valid NNT. Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.
NNH: Not quantifiable. Osimertinib can cause QT prolongation, cardiomyopathy and interstitial lung disease; first-generation EGFR TKIs have their own rash and diarrhoea burden. NNH not quantified from a selected fixed-time excess-harm endpoint.
Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.
Safety and treatment burden
Osimertinib can cause QT prolongation, cardiomyopathy and interstitial lung disease; first-generation EGFR TKIs have their own rash and diarrhoea burden. NNH not quantified from a selected fixed-time excess-harm endpoint.
Follow-up, maturity and limitations
Follow-up: Final OS analysis after extended follow-up.
Evidence applies to common sensitizing EGFR mutations. Acquired resistance remains common; CNS disease and co-mutations affect treatment selection.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.