Abstract 104TiP
Background
Surgery is the standard treatment for early non-small cell lung cancer (NSCLC). However, even after complete surgical resection, about 20% of stage I patients (pts) are still exposed to early recurrence or metastasis. Epidermal growth factor receptor (EGFR) mutation is often a poor prognostic factor for early recurrence and metastasis. There are few treatment options for pts with EGFR-mutant stage IB and stage IA2-3 NSCLC, and lack of standard adjuvant therapy currently. Aumolertinib is a third-generation EGFR-tyrosine kinase inhibitor (EGFR-TKI) approved in China to treat EGFR-mutant NSCLC, and application for listing permission has been accepted by European Medicines Agency (EMA). Preliminary studies have shown that minimal residual disease (MRD) detection plays an important role in guiding treatment and predicting disease progression. The ASSIST (ChiCTR2200063184) study is designed to assess the efficacy and safety of aumolertinib as adjuvant therapy in pts with EGFR-mutant stage IB and stage IA2-3 NSCLC according to MRD detection.
Trial design
This multicenter, open-label, single-arm study is ongoing and aims to enroll approximately 130 pts with histologically confirmed stage IB or stage IA2-3 invasive NSCLC after standard radical surgery, harboring sensitive EGFR mutations, aged 18–75 years, Eastern Cooperative Oncology Group (ECOG) performance status 0–1, and have not previously received chemotherapy, radiotherapy or targeted therapy for NSCLC. Eligible pts receive aumolertinib 110 mg orally once daily until disease progression or complete the overall treatment for 3 years. Stratified by the results of two postoperative MRD detections. Pts receive aumolertinib as adjuvant therapy regardless of whether MRD positive or negative. Plasma samples are collected at week 12 and 24 after surgery and every 24 weeks at each follow-up time to evaluate MRD status. The primary endpoint is disease-free survival (DFS) rate at 3 years. Secondary endpoints include DFS rate at 4 and 5 years, overall survival (OS) and safety. The first patient in (FPI) was in July 2022, and the estimated study completion date is Q3 2024.
Clinical trial identification
ChiCTR2200063184 (release date: September 1, 2022).
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.