| lung cancer (metastatic) | versus No demonstrated result for efficacy osimertinib inferior to placebo in terms of ORR in FLAURA, 2017 (1L patients) | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AURA 3, 2017 | osimertinib vs platinum-based therapy plus pemetrexed | PFS 0.30 [0.22; 0.40] | | | | FLAURA, 2017 | osimertinib vs placebo | PFS 0.45 [0.36; 0.56] | ORR 0.63 [0.45; 0.88] | |
| Trial | Treatments | Patients | Method |
|---|
| AURA 3, 2017 | oral osimertinib (at a dose of 80 mg once daily) (n=-9) vs. intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles (n=-9) | patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed after 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. | Sample size: -9/-9 Primary endpoint: FU duration: | | FLAURA, 2017 | osimertinib (AZD9291) (80 mg or 40 mg orally, once daily) (n=279) vs. first-line standard-of-care treatment erlotinib or gefitinib (n=277) | previously untreated patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancer | double-blind Parallel groups Sample size: 279/277 Primary endpoint: PFS FU duration: crossover permitted |
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