Abstract 725TiP
Background
Concurrent mutations in EGFR sensitive mutations (19 del/21 L858R) are associated with poor prognosis. Previous studies have shown that EGFR-TKI combined with chemotherapy or anti-angiogenic drugs has varying degrees of benefit for this population. However, there has not been reported on the efficacy of EGFR-TKI combination with chemotherapy and anti-angiogenic drugs.
Trial design
This is a single-center, open-label, phase I clinical trial aimed to evaluate the efficacy and safety of osimertinib combined with bevacizumab and chemotherapy (pemetrexed and carboplatin) as first-line treatment of EGFR-mutated advanced non-squamous non-small cell lung cancer with concurrent mutations (NCT05507606). The EGFR mutation includes exon 19 deletion, L858R, T790M, G719X, L861Q, S768I, exon 20 A763-Y764 ins, and concurrent mutations are a combination of at least TP53 gene variant. The primary endpoints were safety and objective disease response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). The endpoints of exploratory analysis included NGS difference analysis before and after treatment, 19del/L858R subgroup analysis, ctDNA clearance and the relationship between efficacy and prognosis. 30 patients will receive osimertinib (80mg/d, d1-21), bevacizumab (7.5mg/kg, d1), pemetrexed (500mg/m2, d1) and carboplatin (AUC 5, d1), Q3W/cycle; induction therapy for 4 cycles, then carboplatin will be stopped after 4 cycles. Osimertinib combined with bevacizumab and pemetrexed will be given for maintenance treatment. Bevacizumab and pemetrexed will be discontinued until 2 years. Osimertinib was continued until disease progression.
Clinical trial identification
NCT05507606.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.