WCLC 2025 - Posters & ePosters-P3.18.08 Alectinib as Adjuvant Therapy in Resected ALK-Positive NSCLC: A Prospective Multicenter Cohort Study in China

P3.18.08 Alectinib as Adjuvant Therapy in Resected ALK-Positive NSCLC: A Prospective Multicenter Cohort Study in China

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This multicenter, prospective cohort study (ML45766, NCT06862869) in China aims to evaluate real-world clinical outcomes and characteristics of adult patients with surgically resected, stage II–IIIB ALK-positive non-small cell lung cancer (NSCLC) treated with alectinib as adjuvant therapy. Approximately 4%-5% of NSCLC patients harbor ALK-positive disease, with similar prevalence among Chinese patients. Alectinib, approved in China in July 2024 based on the global phase 3 ALINA trial, is the first ALK tyrosine kinase inhibitor (TKI) used as adjuvant treatment, having demonstrated significantly improved disease-free survival (DFS) and favorable tolerability over platinum-based chemotherapy. It is now the standard of care and recommended by guidelines (NCCN, ESMO, CSCO) and included in the 2025 China National Reimbursement Drug List, enhancing accessibility.<br /><br />The study plans to enroll 800 patients from over 50 sites across 12 Chinese provinces, with 15 sites activated as of July 2025. Eligible patients are adults (≥18 years) with histologically confirmed stage II–IIIA or selected IIIB (T3N2) ALK-positive NSCLC who have undergone complete surgical resection and started alectinib within 28 days of enrollment without prior systemic therapy. Key endpoints include real-world DFS from first alectinib dose to recurrence or death (primary), duration of alectinib therapy, safety, patient-reported outcomes (PROs), and disease characteristics (secondary). Exploratory analyses include recurrence prognostic factors, healthcare utilization, biomarker alterations at recurrence, and subsequent treatments.<br /><br />The study utilizes a decentralized design leveraging digital tools for real-time data capture from medical records and patient self-reporting. Data collection will continue for 30 months post last patient enrollment or until recurrence treatment initiation, death, withdrawal, or study termination. The study is funded by Shanghai Roche Pharmaceuticals Ltd. and acknowledges participating patients and caregivers.

Asset Subtitle

Chang Chen

Meta Tag

Speaker Chang Chen

Topic Clinical Trials in Progress

Keywords

ALK-positive NSCLC

alectinib

adjuvant therapy

real-world study

disease-free survival

surgical resection

China

multicenter cohort

tyrosine kinase inhibitor

patient-reported outcomes