Abstract 728TiP
Background
In FLAURA2 study, osimertinib combined with chemotherapy (pemetrexed plus either cisplatin or carboplatin) as first-line(1L) therapy has demonstrated statistically significant and clinically meaningful progression-free survival (PFS) benefits by approximately 9 months in patients(pts) with EGFR mutation (EGFRm) advanced NSCLC compared to osimertinib monotherapy. However, the data of diverse treatment patterns (chemotherapy regimen, number of induction chemotherapy cycles, duration of chemotherapy maintenance, chemotherapy dose intensity, etc.) and impact on clinical outcome of 1L osimertinib plus chemotherapy in real-world setting is limited. Further evaluate the effectiveness and safety of osimertinib plus chemotherapy as 1L in real-world setting is very essential for clinical practice.
Trial design
This is a prospective, multi-centre, real-world study with the aim to assess the effectiveness and safety of 1L osimertinib plus chemotherapy in pts with locally advanced or metastatic, EGFRm NSCLC in real-world setting. Pts who receive osimertinib plus chemotherapy as the 1L treatment will be enrolled. The chemotherapy regimens will depend on physician’s medical assessment. Adult pts with histologically or cytologically documented non-squamous, stage IIIB/IIIC/IV NSCLC, EGFR sensitive mutation and ECOG performance status of 0 to 2 are eligible. Approximately 700 Chinese pts from 60 sites will be enrolled in the study. The primary endpoint is median PFS by investigator assessment in real-world setting. Secondary endpoints include treatment pattern and dose intensity of 1L therapy, response rate, duration of response (DoR), overall survival (OS), and safety. Exploratory endpoints include secondary PFS, time to treatment discontinuation (TTD), time to first subsequent treatment (TFST). CNS Response rate, CNS PFS, subsequent treatment pattern, progression patterns after first-line osimertinib plus chemotherapy failure and the genomic profile in the pts who had disease progression on 1L osimertinib plus chemotherapy.
Clinical trial identification
NCT06376084.
Legal entity responsible for the study
AstraZeneca China.
Funding
AstraZeneca China.
Disclosure
All authors have declared no conflicts of interest.