FLAURA, 2017 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

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 sizes	279 / 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

Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramali Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med 2017;: [PMID: 29151359] link to pdf add to Mendeley

Links

press release

ClinicalTrial.gov record NCT02296125

Registering number	NCT02296125 (see trial on clinicaltrials.gov)
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