2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.12H.01 A Phase 2 Study to Assess BDTX-1535, An Oral EGFR Inhibitor, in Patients with Non-Small Cell Lung Cancer

EP.12H.01 A Phase 2 Study to Assess BDTX-1535, An Oral EGFR Inhibitor, in Patients with Non-Small Cell Lung Cancer

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The document discusses a Phase 2 clinical study evaluating BDTX-1535, an oral inhibitor targeting the epidermal growth factor receptor (EGFR) for non-small cell lung cancer (NSCLC). The aim is to assess the safety and efficacy of BDTX-1535 in patients with first-line (1L), second-line (2L), or third-line (3L) EGFR-mutated NSCLC, either with or without central nervous system (CNS) disease. <br /><br />BDTX-1535 is a fourth-generation tyrosine kinase inhibitor (TKI) designed to address a broad range of EGFR mutations, including classical drivers, non-classical drivers, and acquired resistance mutations like C797S. It offers advantages over existing therapies by providing better activity against diverse mutations, improved brain penetrance, and enhanced tolerability. The study is open-label and multicenter, focusing on enrolling patients who either haven't responded to previous treatments or present with specific EGFR mutations identified via next-generation sequencing (NGS). <br /><br />The trial assesses multiple endpoints: the objective response rate (ORR) using RECIST v1.1 and/or RANO-BM criteria, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety, alongside pharmacokinetics and biomarker evaluations. <br /><br />Eligible patients include adults with measurable EGFR-mutation-positive NSCLC, ECOG performance status of 0 or 1, and without small cell lung cancer transformation. Exclusions apply to those with other actionable mutations like T790M, as well as previous severe reactions to EGFR TKIs or urgent CNS conditions. <br /><br />The study is actively recruiting at numerous sites across the U.S., including locations in California, New York, Texas, and others. BDTX-1535 is anticipated to offer a novel solution for unmet needs in NSCLC therapy by providing a targeted, versatile, and more tolerable treatment option for patients with diverse EGFR mutations.

Asset Subtitle

Sudharshan Eathiraj

Meta Tag

Speaker Sudharshan Eathiraj

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

BDTX-1535

EGFR inhibitor

non-small cell lung cancer

NSCLC

tyrosine kinase inhibitor

EGFR mutations

clinical study

pharmacokinetics

biomarker evaluations

multicenter trial