Open AccessNeoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for EGFR-mutated resectable non-small-cell lung cancer: NeoADAURA
Author(s) -
Masahiro Tsuboi,
Walter Weder,
Carles Escriu,
Collin M. Blakely,
Jianxing He,
Sanja Đačić,
Yasushi Yatabe,
Leilei Zeng,
Andrew Walding,
Jamie E. Chaft
Publication year - 2021
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2021-0549
Subject(s) - medicine , osimertinib , t790m , lung cancer , oncology , chemotherapy , clinical endpoint , tolerability , tyrosine kinase inhibitor , epidermal growth factor receptor , cancer , clinical trial , gefitinib , erlotinib , adverse effect
Osimertinib is a third-generation, irreversible oral EGFR-tyrosine kinase inhibitor), that potently inhibits EGFR-tyrosine kinase inhibitor-sensitizing mutations and T790M resistance mutations together with efficacy in CNS metastases in patients with non-small-cell lung cancer (NSCLC). Here we describe the rationale and design for the Phase III NeoADAURA study (NCT04351555), which will evaluate neoadjuvant osimertinib with or without chemotherapy versus chemotherapy alone prior to surgery, in patients with resectable stage II–IIIB N2 EGFR mutation-positive NSCLC. The primary end point is centrally assessed major pathological response at the time of resection. Secondary end points include event-free survival, pathological complete response, nodal downstaging at the time of surgery, disease-free survival, overall survival and health-related quality of life. Safety and tolerability will also be assessed. Trial Registration number: NCT04351555 (ClinicalTrials.gov)