Background

This study, conducted by Pfizer, aims to assess the utilization of lorlatinib as a first‑line therapy for ALK‑positive non‑small cell lung cancer (NSCLC) in adult patients in China through a retrospective real‑world analysis. Initiated on April 22, 2026, the objective is to understand treatment patterns and patient characteristics in routine clinical practice.

Design and Population

Patients aged 18 years or older with a diagnosis of ALK‑positive NSCLC who initiated lorlatinib as first‑line therapy during the selection period are included. The primary aim is to characterize patient demographics and treatment patterns to generate real‑world evidence that can inform future guideline recommendations.

Current Treatment Landscape and Differentiation

Historically, crizotinib, alectinib, and brigatinib have been employed. Lorlatinib, an ALK/ROS1 inhibitor, is expected to provide superior intracranial activity and to delay the emergence of resistance compared with first‑ and second‑generation inhibitors. Accumulating real‑world data will enable verification of how these differentiators translate into clinical practice.

Market and Patient Impact

China has the largest NSCLC patient population globally, with a substantial number of ALK‑mutated cases. Real‑world evidence supporting first‑line use of lorlatinib could prompt local clinicians and health authorities to reassess treatment choices, potentially expanding market share and influencing pricing and reimbursement policies.

Risks and Outlook

As a retrospective study, limitations such as data quality and selection bias may arise, and the lack of comparative data with competitors’ latest third‑generation inhibitors hampers direct assessment of competitive advantage. Nonetheless, the accumulation of real‑world evidence will provide critical insights for the design of prospective trials and regulatory approval strategies.