2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.12H.04 Phase II Study of Brigatinib for ALK-Positive Advanced Non-Small Cell Lung Cancer with Brain Metastases: BRAVES Trial (LOGIK2201)

EP.12H.04 Phase II Study of Brigatinib for ALK-Positive Advanced Non-Small Cell Lung Cancer with Brain Metastases: BRAVES Trial (LOGIK2201)

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The document outlines a Phase II clinical trial (LOGIK2201:BRAVES) evaluating the efficacy of brigatinib, a targeted ALK-inhibitor medication, in treating patients with advanced non-small cell lung cancer (NSCLC) that is ALK-positive and features untreated brain metastases. This specific subgroup, which holds about 3-5% of NSCLC patients, typically presents significant challenges due to its correlation with poor prognosis, with roughly 30-35% showing brain metastases at diagnosis. Previous data from a phase trial (ALTA-1L) suggested potential benefits of brigatinib for central nervous system (CNS) metastases, but the sample size was small and symptomatic patients were excluded.<br /><br />The current study adopts a single-arm phase trial design aiming to clarify the genuine efficacy of brigatinib. It involves ALK-positive NSCLC patients over 20 years old who are ALK-TKI naïve, with untreated brain metastases of at least 5mm. The trial consists of an initial 7-day lead-in dose of 90mg brigatinib, followed by 180mg daily until disease progression.<br /><br />Primary and secondary endpoints include intracranial response rate, intracranial and extracranial progression-free survival (PFS), systemic response rate, overall survival, and safety. The intracranial response rate is anticipated to be 70%, with a planned enrollment of 22 patients to enable a statistically significant conclusion. As of August 2024, seven patients have been enrolled across 25 sites in Japan. The enrollment period extends from June 2023 to March 2025.<br /><br />The study is a collaborative effort by the Lung Oncology Group in Kyushu, with data management by the Clinical Research Support Center Kyushu, and funding provided by Takeda Pharmaceutical Company Limited.

Asset Subtitle

Yoshiro Nakahara

Meta Tag

Speaker Yoshiro Nakahara

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

Phase II clinical trial

brigatinib

ALK-inhibitor

non-small cell lung cancer

ALK-positive

brain metastases

intracranial response rate

progression-free survival

Lung Oncology Group Kyushu

Takeda Pharmaceutical