2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.12H.06 A Patient-Centric, Phase II Trial of First-Line Lorlatinib&alk TKIs in China Advanced ALK+ Non-Small Cell Lung Cancer

EP.12H.06 A Patient-Centric, Phase II Trial of First-Line Lorlatinib&alk TKIs in China Advanced ALK+ Non-Small Cell Lung Cancer

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The document discusses a patient-centric, Phase II trial in China, focusing on first-line treatments for advanced ALK-positive non-small cell lung cancer (NSCLC) using the third-generation ALK tyrosine kinase inhibitor (TKI), lorlatinib. Lorlatinib has shown strong efficacy and manageable side effects in the CROWN study, but there's limited data on its impacts in the Chinese population. This study aims to fill that gap by providing more generalizable data to aid clinical decisions.<br /><br />The trial employs a three-cohort, open-label, multi-center design, planning to enroll 189 patients. It consists of two treatment intervention cohorts and a real-world observing (RO) cohort. The treatment cohorts include: <br />1. The CROWN criteria (CC) cohort, with 84 subjects meeting stringent eligibility criteria, and <br />2. The Expand Eligibility Criteria (EC) cohort, with 42 subjects not qualifying for the CROWN criteria. <br /><br />These cohorts will receive lorlatinib until disease progression, unacceptable toxicity, withdrawal, or death. Key endpoints include progression-free survival (PFS), mechanisms of resistance, objective response rate (ORR), overall survival (OS), safety, and patient-reported outcomes (PROs).<br /><br />Additionally, 63 treatment-naive subjects in the RO cohort will receive a variety of ALK TKIs, such as crizotinib, ceritinib, or brigatinib, to compare with lorlatinib treatment. The primary endpoint for this cohort is real-world progression-free survival (rwPFS).<br /><br />The trial places emphasis on gathering real-world data and evaluating the effectiveness and safety of different ALK TKIs. Exploratory investigations will focus on potential biomarkers and the dynamics of circulating tumor DNA (ctDNA) during treatment, aiming to develop effective treatment strategies following lorlatinib resistance. This study provides pivotal insights into the benefit-risk profile of lorlatinib and other ALK TKIs in a broader patient population in China.

Asset Subtitle

Jiaxin Lin

Meta Tag

Speaker Jiaxin Lin

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

patient-centric

Phase II trial

ALK-positive NSCLC

lorlatinib

CROWN study

China

progression-free survival

real-world data

ALK TKIs

circulating tumor DNA