Efficacy and safety of lorlatinib in first-line and subsequent-line treatments for patients with ALK-positive non-small cell lung cancer: a single-center real-world study in China.

Background: Current evidence on the efficacy and safety of lorlatinib as first-line or subsequent-line therapy for patients with anaplastic lymphoma kinase ( Methods: This study is a single-center cohort study in China. We retrospectively and prospectively collected data on patients with advanced or metastatic Results: As of July 18, 2025, a total of 36 patients were enrolled in the lorlatinib first-line treatment cohort, and 43 patients were enrolled in the lorlatinib subsequent-line treatment cohort for analysis. For the first-line treatment cohort, the median follow-up time was 12.7 months and the median progression-free survival (PFS) had not yet been reached; the objective response rate (ORR) was 82.9%, and the disease control rate (DCR) was 100%. For the subsequent-line treatment cohort, the median follow-up time was 19.9 months and the median PFS was 16.8 months; the ORR was 40.5%, and the DCR was 92.9%. Among all patient groups included in this study, the adverse events associated with lorlatinib treatment predominantly comprised hypercholesterolemia, hypertriglyceridemia, edema, cognitive impairment/mood disorders, elevated transaminases, weight gain, and peripheral neuropathy. No cases of interstitial lung disease were observed. The overall safety profile of lorlatinib is manageable. Analysis of next-generation sequencing (NGS) test results from patients with lorlatinib resistance demonstrated that Conclusions: Lorlatinib has shown remarkable efficacy in both first-line and subsequent-line treatment settings for patients with locally advanced or metastatic