Study of Lorlatinib Treatment for Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer in France

What this Trial Is About

Researchers are evaluating the effectiveness and safety of lorlatinib in patients with untreated ALK-positive non-small-cell lung carcinoma NSCLC in a real-world French context. This study, sponsored by Pfizer, focuses on adults aged 18 years and older who have locally advanced or metastatic ALK-positive NSCLC confirmed by specific diagnostic tests. The goal is to understand how lorlatinib works and its safety profile outside of controlled clinical trial settings. Participants in this study receive lorlatinib as a single agent at a dose of 100 mg taken orally once daily without interruption. The treatment continues as per routine care, and patients undergo thorough radiological evaluations including contrast-enhanced CT scans of the thorax and upper abdomen, as well as brain MRI, before starting lorlatinib. The study monitors various outcomes such as progression-free survival, overall survival, response rates, duration of response, and adverse events over a period of up to 48 months. Throughout the study, participants will have scheduled assessments at regular intervals including clinical evaluations, imaging studies, and questionnaires to track symptoms, treatment adherence, and quality of life. Researchers will also monitor for specific side effects, treatment resistance mechanisms, and changes in patient-reported outcomes related to central nervous system toxicity and overall health status. The total duration of participation includes follow-up visits lasting up to 48 months to gather long-term data on treatment effects and safety.

Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context