Abstract
Background Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown. Methods In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or 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; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line
Original language | Undefined/Unknown |
---|---|
Pages (from-to) | 629-640 |
Number of pages | 12 |
Journal | New England Journal of Medicine |
Volume | 376 |
Issue number | 7 |
DOIs | |
Publication status | Published - Feb 1 2017 |
Keywords
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use, Carcinoma, Non-Small-Cell Lung/*drug therapy, Disease-Free Survival, Female, Humans, Lung Neoplasms/*drug therapy, Male, Middle Aged, Mutation, Pemetrexed/*administration dosage/adverse effects, Piperazines/*administration dosage/adverse effects, Platinum/administration dosage, Receptor, Epidermal Growth Factor/*antagonists inhibitors, Young Adult