WCLC 2025 - Posters & ePosters-EP.18.06 ML44840: A Multicenter Prospective Cohort Study of the Patient-Reported Outcomes in Chinese Patients With ALK+ Advanced NSCLC

EP.18.06 ML44840: A Multicenter Prospective Cohort Study of the Patient-Reported Outcomes in Chinese Patients With ALK+ Advanced NSCLC

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This multicenter prospective cohort study (NCT06586801) evaluates patient-reported outcomes (PROs) and safety in Chinese patients with ALK-positive advanced non-small cell lung cancer (NSCLC) receiving first-line ALK tyrosine kinase inhibitors (ALK-TKIs). ALK rearrangements occur in 3–8% of NSCLC cases, and treatment with ALK-TKIs, including first-generation crizotinib and next-generation agents like alectinib and lorlatinib, has improved survival significantly, with alectinib showing a 7-year overall survival of 56%. Despite this, maintaining quality of life (QoL) is challenging as only about 30% of patients feel QoL goals are met, partly due to adverse drug reactions varying by TKI. <br /><br />This observational study plans to enroll approximately 200 ALK-positive locally advanced or metastatic NSCLC patients across multiple centers in China. Patients will be assigned to one of three cohorts based on their first-line ALK-TKI treatment: alectinib (N=100), lorlatinib (N=50), or other ALK-TKIs (N=50), with treatment choice at physicians' discretion. Inclusion criteria include ALK positivity confirmed by standard tests and ECOG status 0-2, allowing asymptomatic CNS metastases. Patients will be followed for up to 12 months to assess PROs and safety.<br /><br />PRO measures include validated questionnaires such as EORTC QLQ-C30, QLQ-LC13, PRO-CTCAE items, and EORTC IL46, assessed at multiple time points to monitor symptom burden, QoL, and treatment tolerability. The study employs decentralized enrollment via traditional sites, collaborating physicians, pharmacies, patient communities, and social media, achieving enrollment of 105 patients from 20 Chinese provinces as of August 2025.<br /><br />The study aims to provide real-world evidence on how ALK-TKI therapy affects symptom burden and QoL in Chinese ALK NSCLC patients, supporting optimized risk-benefit assessments of frontline targeted therapies in this population.

Asset Subtitle

Fei Zhou

Meta Tag

Speaker Fei Zhou

Topic Clinical Trials in Progress

Keywords

ALK-positive NSCLC

ALK tyrosine kinase inhibitors

first-line ALK-TKIs

alectinib

lorlatinib

patient-reported outcomes

quality of life

adverse drug reactions

multicenter prospective cohort study

Chinese lung cancer patients