Treatment Rationale and Design of a Phase III Study of Afatinib or Chemotherapy in Patients with Non–small-cell Lung Cancer Harboring Sensitizing Uncommon Epidermal Growth Factor Receptor Mutations (ACHILLES/TORG1834)

Lynch, 2004, Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib, N Engl J Med, 350, 2129, 10.1056/NEJMoa040938 Paez, 2004, EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy, Science, 304, 1497, 10.1126/science.1099314 Kobayashi, 2016, Not all epidermal growth factor receptor mutations in lung cancer are created equal: perspectives for individualized treatment strategy, Cancer Sci, 107, 1179, 10.1111/cas.12996 Maemondo, 2010, North-East Japan Study Group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR, N Engl J Med, 362, 2380, 10.1056/NEJMoa0909530 Mitsudomi, 2010, West Japan Oncology Group. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial, Lancet Oncol, 11, 121, 10.1016/S1470-2045(09)70364-X Zhou, 2011, Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study, Lancet Oncol, 12, 735, 10.1016/S1470-2045(11)70184-X Rosell, 2012, Lancet Oncol, 13, 239, 10.1016/S1470-2045(11)70393-X Sequist, 2013, Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations, J Clin Oncol, 31, 3327, 10.1200/JCO.2012.44.2806 Wu, 2014, Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial, Lancet Oncol, 15, 213, 10.1016/S1470-2045(13)70604-1 Kim, 2016, Compound EGFR mutation is frequently detected with co-mutations of actionable genes and associated with poor clinical outcome in lung adenocarcinoma, Cancer Biol Ther, 17, 237, 10.1080/15384047.2016.1139235 Banno, 2016, Sensitivities to various epidermal growth factor receptor-tyrosine kinase inhibitors of uncommon epidermal growth factor receptor mutations L861Q and S768I: what is the optimal epidermal growth factor receptor-tyrosine kinase inhibitor?, Cancer Sci, 107, 1134, 10.1111/cas.12980 Watanabe, 2014, Effectiveness of gefitinib against non-small-cell lung cancer with the uncommon EGFR mutations G719X and L861Q, J Thorac Oncol, 9, 189, 10.1097/JTO.0000000000000048 Shen, 2017, Comparing the effects of afatinib with gefitinib or erlotinib in patients with advanced-stage lung adenocarcinoma harboring non-classical epidermal growth factor receptor mutations, Lung Cancer, 110, 56, 10.1016/j.lungcan.2017.06.007 Cho, 2020, Osimertinib for patients with non-small-cell lung cancer harboring uncommon EGFR mutations: a multicenter, open-label, phase II trial (KCSG-LU15-09), J Clin Oncol, 38, 488, 10.1200/JCO.19.00931 Hanna, 2020, Therapy for stage IV non-small-cell lung cancer without driver alterations: ASCO and OH (CCO) Joint Guideline Update, J Clin Oncol, 38, 1608, 10.1200/JCO.19.03022 Kohsaka, 2017, A method of high-throughput functional evaluation of EGFR gene variants of unknown significance in cancer, Sci Transl Med, 9, eaan6566, 10.1126/scitranslmed.aan6566 Yang, 2015, Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6, Lancet Oncol, 16, 830, 10.1016/S1470-2045(15)00026-1