2024 World Conference on Lung Cancer (WCLC) - Posters-P3.08F.08 NEOLA: Phase II Study of Osimertinib Treatment Before and after Chemoradiotherapy in Unresectable Stage III EGFRm NSCLC

P3.08F.08 NEOLA: Phase II Study of Osimertinib Treatment Before and after Chemoradiotherapy in Unresectable Stage III EGFRm NSCLC

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The document outlines the NEOLA study, a Phase II clinical trial assessing the efficacy and safety of osimertinib as induction therapy prior to, and following, chemoradiotherapy (CRT) for patients with unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC). Osimertinib, a third-generation EGFR-tyrosine kinase inhibitor (TKI), is known for its efficacy in treating both early-stage surgically resectable and advanced forms of EGFR-mutated NSCLC.<br /><br />The NEOLA study builds on findings from the LAURA study, which showed a significant progression-free survival (PFS) benefit for osimertinib as a post-CRT therapy. NEOLA aims to evaluate osimertinib's potential as an induction treatment before CRT in a similar patient population. The trial targets adult patients with confirmed EGFR mutations (Ex19del or L858R), unresectable stage III NSCLC, and who are eligible for CRT. Patients will receive osimertinib daily for 8 weeks before CRT, continue CRT, and then resume osimertinib until disease progression or other criteria necessitate discontinuation.<br /><br />Key criteria for participation include a minimum age of 18, specific EGFR mutations, and a World Health Organization performance status of 0 or 1. Exclusion criteria encompass the presence of any small-cell histology, prior EGFR-TKI therapy, unresolved toxicities above grade 1, and specific medical histories such as interstitial lung disease.<br /><br />The study's endpoints involve PFS per RECIST v1.1 criteria, objective response rate, disease control rate, overall survival, and safety. Funded by AstraZeneca, NEOLA seeks to further understand the role of osimertinib in optimizing treatment outcomes for this patient population. Completion is anticipated by March 2028. More information can be accessed through the study's ClinicalTrials.gov identifier NCT06194448.

Asset Subtitle

Heather Wakelee

Meta Tag

Speaker Heather Wakelee

Topic Local-Regional NSCLC

Keywords

NEOLA study

Phase II clinical trial

osimertinib

induction therapy

chemoradiotherapy

EGFR-mutated NSCLC

progression-free survival

EGFR-tyrosine kinase inhibitor

AstraZeneca

ClinicalTrials.gov NCT06194448