2024 Asia Conference on Lung Cancer (ACLC) - Poster & ePosters-PP02.28

PP02.28 - Jia Zhong

Pdf Summary

The FLAME study is a multicenter, phase II randomized controlled trial designed to evaluate the efficacy and safety of osimertinib alone versus in combination with chemotherapy in patients with locally advanced or metastatic EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC) who show persistent plasma circulating tumor DNA (ctDNA) with EGFR mutations after three weeks of first-line osimertinib treatment. This trial focuses on patients whose ctDNA EGFRm persistence suggests a shorter median progression-free survival (mPFS), as earlier exploratory analyses from the FLAURA study had indicated.<br /><br />Key inclusion criteria for the study include adults with performance status 0–1, stage IIIB, IIIC, or IV non-squamous EGFRm NSCLC who have not previously received systemic treatment, and who have stable CNS metastases. Exclusion criteria include inadequate hematological, liver, and renal function, cardiac diseases, active infections such as hepatitis B, C, or HIV, and unresolved toxicities from prior therapies.<br /><br />The primary endpoint of the study is progression-free survival as assessed by RECIST 1.1 criteria. Secondary endpoints include overall survival rate, objective response rate, disease control rate, duration of response, safety, and acquired resistance mechanisms. Exploratory endpoints include evaluating ctDNA EGFRm changes, molecular alterations over time through next-generation sequencing (NGS), and their correlations with clinical outcomes.<br /><br />Patients are assessed for efficacy based on RECIST 1.1 guidelines at set intervals following randomization until disease progression is noted. Post-progression, follow-ups are conducted every 12 weeks until the study concludes. The study enrolled 80 patients from 18 sites in China and was completed in July 2024. Sponsored by the Beijing Cancer Prevention & Treatment Society, it was funded by AstraZeneca and holds the trial number NCT04769388.

Keywords

FLAME study

osimertinib

chemotherapy

EGFR mutation

non-small cell lung cancer

ctDNA

progression-free survival

RECIST 1.1

next-generation sequencing

AstraZeneca