Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for EGFR-mutated resectable non-small-cell lung cancer: NeoADAURA.
Masahiro TsuboiWalter WederCarles EscriuCollin M BlakelyJianxing HeSanja DacicYasushi YatabeLingmin ZengAndrew WaldingJamie E ChaftPublished in: Future oncology (London, England) (2021)
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).
Keyphrases
- small cell lung cancer
- locally advanced
- free survival
- epidermal growth factor receptor
- rectal cancer
- phase iii
- neoadjuvant chemotherapy
- advanced non small cell lung cancer
- squamous cell carcinoma
- radiation therapy
- open label
- brain metastases
- tyrosine kinase
- minimally invasive
- lymph node
- clinical trial
- coronary artery bypass
- phase ii
- surgical site infection
- percutaneous coronary intervention
- double blind
- chemotherapy induced
- placebo controlled
- acute coronary syndrome