FLAURA, trial summary

A randomised clinical trial investigating the effect of osimertinib versus placebo in previously untreated patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer

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NCT02296125    



Studied treatment osimertinib (AZD9291) (80 mg or 40 mg orally, once daily)
AZD9291 (80 mg or 40 mg orally, once daily) plus placebo Erlotinib (150 mg or 100 mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily)
Control treatment first-line standard-of-care treatment erlotinib or gefitinib
Erlotinib (150 mg or 100 mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily) plus placebo AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomisation schedule



Patients previously untreated patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer
Group sizes279 / 277
patients



Blindness double-blind Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint PFS Design Parallel groups
EGFR mutation EGFR T790M mutation

crossover permitted



EndpointX1N1X0N0TE95% CI OS - 279 - 277 no data PFS - 279 - 277 0,45[0,36; 0,56] ORR - 279 - 277 0,63[0,45; 0,88]0,22,01,0

Links

press release

ClinicalTrial.gov record NCT02296125



Registering number NCT02296125 (see trial on clinicaltrials.gov)
Code Name