NeoADAURA：EGFR基因突变可切除非小细胞肺癌新辅助奥希替尼±化疗

Phase III, Randomized, Controlled, Multicenter Study of Neoadjuvant Osimertinib in EGFRm Resectable NSCLC


Stratification:
Stage II/III
Non
Asian/
Chinese/
other Asian
Ex19del/L858R

Double-blind treatment arms:
1. Placebo + investigator’s choice of pemetrexed 500 mg/m 2 plus carboplatin AUC5 mg/ ml.min or cisplatin 75 mg/m 2
2.Osimertinib 80 mg qd + investigator’s choice of pemetrexed 500 mg/m 2 plus carboplatin AUC5 mg/ ml.min or cisplatin 75 mg/m 2

Open-label (sponsor blind) treatment arm:
3. Osimertinib 80 mg qd

Adjuvant therapy at investigator’s discretion:
• Up to 5 years until disease recurrence or withdrawal of consent
• Osimertinib will be offered to all patients who complete surgery (+/ post surgical chemotherapy) for up to 3 years
• Follow up at 12 and 24 weeks post surgery, then every 24 weeks

NeoADAURA (NCT04351555)

III

II–IIIB (N2)

Osimertinib vs osimertinib + CT vs  placebo + CHT → surgery → investigator choice (osimertinib for 3 y)

328

MPR

NeoADAURA试验的目的是评估新辅助奥希替尼联合或不联合化疗的疗效，但根据研究者对最优治疗的选择，允许使用奥希替尼或化疗进行辅助全身治疗。