Abstract 80TiP
Background
Third-generation EGFR-TKIs have demonstrated superior CNS efficacy compared with first-generation EGFR-TKIs or chemotherapy in previous phase III studies (AENEAS, FLAURA, AURA3). However, there is a lack of head-to-head comparison of CNS efficacy between third-generation EGFR-TKIs. Herein, we conduct the ATTACK study to evaluate the efficacy and safety of aumolertinib compared with osimertinib in EGFR T790M+ NSCLC patients with brain metastases.
Trial design
ATTACK is a multicenter, open-label, randomized, controlled trial. Patients with histologic or cytologic confirmation of advanced NSCLC and are known to have progression of radiologic disease on first- or second-generation EGFR-TKIs and harbor an EGFR T790M mutation are eligible. At baseline, patients are required to have at least one measurable intracranial lesion, defined as ≥10 mm. Approximately 232 patients will be randomized (1:1) to receive either 165 mg aumolertinib or 80 mg osimertinib, administered once daily orally, stratified by the type of EGFR mutation (Ex19del or L858R). Treatment continues in 21-day cycles until disease progression, withdrawal of consent, the development of unacceptable side effects, or the fulfillment of other discontinuation criteria. The primary endpoint is intracranial progression free survival (iPFS). Secondary endpoints include PFS, objective response rate (ORR), disease control rate (DCR), intracranial ORR (iORR), intracranial DCR (iDCR), overall survival (OS), and safety. Adverse effects are graded per CTCAE v.5.0. The first patient had been enrolled in November 2022.
Clinical trial identification
NCT04870190.
Legal entity responsible for the study
Shanghai Chest Hospital.
Funding
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Disclosure
S. Lu: Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer, Boehringer Ingelheim, Hutchison MediPharma, Simcere Pharmaceutical Group, Zai Lab, GenomiCare, Yuhan, Prime Oncology, Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche, Hansoh Pharma, Hengrui Therapeutics; Financial Interests, Personal, Research Grant: AstraZeneca (Inst), Hutchison MediPharma (Inst), BMS (Inst), Hengrui Therapeutics (Inst), BeiGene (Inst), Roche (Inst). All other authors have declared no conflicts of interest.