Abstract 98TiP
Background
Aumolertinib has superior efficacy as the first-line standard treatment based on the AENEAS study, but its efficacy against concurrent mutations is still unclear, especially for the high incidence (up to 55%-65%) of TP53 co-mutation. In recent RELAY and ACTIVE studies, subgroup analysis has shown particular benefits for patients from the dual inhibition of EGFR and angiogenesis. Herein, we conduct a prospective study to examine aumolertinib plus anlotinib as a first-line treatment option for advanced NSCLC harbouring EGFR mutation with TP53 co-mutation. (NCT05778149).
Trial design
This is a phase II clinical study with a single-arm, exploratory design. 47 patients are scheduled to be enrolled. The key inclusion criteria are as follows:1) Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R) and TP53 co-mutation; 2) Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early NSCLC and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered; 3) ECOG 0-1, the expected survival is more than 6 months; 4)At least one assessable lesion (RECIST 1.1 ). Treatment regimen is aumolertinib 110mg p.o. QD daily and anlotinib 12mg p.o. QD for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death. The primary endpoint is progression free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. In addition, we also try to explore predictive or prognostic biomarkers (tissue and/or plasma) related to disease treatment response or drug resistance. Analyze the potential biomarkers in the biopsy tissue samples and blood samples after the disease progresses, and explore the possible mechanism of treating drug resistance. The first patient had been enrolled in February, 2022.
Clinical trial identification
NCT05778149.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.