NCT07083687

Lorlatinib in ROS1+ NSCLC With Brain Metastasis

A Phase 2, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Lorlatinib in TKI naïve, Advanced ROS1-Positive Non-Small Cell Lung Cancer Patients With Brain Metastases

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-naïve, 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 once daily until disease progression or unacceptable toxicity. Undergo brain MRI/CT scans every 8 weeks (first 12 cycles) and every 16 weeks thereafter. Provide blood samples for safety/biomarker analysis and optional CSF samples via lumbar puncture during scheduled visits.

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Lorlatinib 100 mg	After enrollment, patients will receive 100 mg of lorlatinib orally once daily until disease progression, unacceptable toxicity, or withdraw study .

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-01-01
• Completion: 2028-12-01
• First posted: 2025-07-24
• Last updated: 2025-07-24