2021
DOI: 10.2217/fon-2021-0549
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Neoadjuvant Osimertinib With/Without Chemotherapy Versus Chemotherapy Alone for EGFR -Mutated Resectable Non-Small-Cell Lung Cancer: NeoADAURA

Abstract: 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 res… Show more

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Cited by 107 publications
(65 citation statements)
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“… Chen et al (2021) has reported the clinical efficacy of a stage IIIa NSCLC patient who received osimertinib as neoadjuvant therapy in combination with radiotherapy followed by surgery ( Chen et al, 2021 ). A phase 3 NeoADAURA study has been initiated in 2020 to evaluate the safety and efficacy of neoadjuvant osimertinib alone or in combination with chemotherapy compared to chemotherapy alone for patients with stage II-IIIb EGFR-mutated NSCLC ( Tsuboi et al, 2021 ). Recently, a phase II clinical trial evaluating the efficacy and safety of neoadjuvant osimertinib (80 mg QD for 6 weeks) for resectable EGFR-mutated lung adenocarcinoma (NEOS study) updated its findings at the 2022 ELCC meeting.…”
Section: Discussionmentioning
confidence: 99%
“… Chen et al (2021) has reported the clinical efficacy of a stage IIIa NSCLC patient who received osimertinib as neoadjuvant therapy in combination with radiotherapy followed by surgery ( Chen et al, 2021 ). A phase 3 NeoADAURA study has been initiated in 2020 to evaluate the safety and efficacy of neoadjuvant osimertinib alone or in combination with chemotherapy compared to chemotherapy alone for patients with stage II-IIIb EGFR-mutated NSCLC ( Tsuboi et al, 2021 ). Recently, a phase II clinical trial evaluating the efficacy and safety of neoadjuvant osimertinib (80 mg QD for 6 weeks) for resectable EGFR-mutated lung adenocarcinoma (NEOS study) updated its findings at the 2022 ELCC meeting.…”
Section: Discussionmentioning
confidence: 99%
“…However, in a neoadjuvant setting, it is still not clear whether EGFR-TKIs or immunotherapy should be given in the first place to those with EGFR mutations. The Phase III NeoADAURA study will evaluate the efficacy and safety of neoadjuvant osimertinib in patients with resectable EGFR-mutant NSCLC ( 17 ). In the current study, we have reported a stage IIIA EGFR mutant NSCLC with high PD-L1 expression, for whom nivolumab plus chemotherapy brought little benefit.…”
Section: Discussionmentioning
confidence: 99%
“…In the NeoADAURA trial, patients with resectable II-IIIB N2 disease will be enrolled for either neoadjuvant osimertinib with or without chemotherapy versus neoadjuvant chemotherapy. MPR is the primary endpoint [ 63 ].…”
Section: Stage Iiia-n2 Diseasementioning
confidence: 99%