U.S., July 25 -- ClinicalTrials.gov registry received information related to the study (NCT07083687) titled 'Lorlatinib in ROS1+ NSCLC With Brain Metastasis' on June 27.
Brief Summary: The goal of this Phase II, multicenter, open-label, single-arm clinical trial is to evaluate the intracranial efficacy and safety of lorlatinib in adults with TKI-naive, advanced ROS1-positive non-small cell lung cancer (NSCLC) and untreated brain metastases. The main questions it aims to answer are:
What is the intracranial efficacy (eg., objective response rate/PFS) assessed by revised RECIST v1.1?
How do exploratory biomarkers (e.g., ctDNA dynamics in plasma/CSF) correlate with lorlatinib resistance?
Participants will:
Receive lorlatinib 100 mg orally...