Lorlatinib Clinical Trial for Advanced ROS1-Positive NSCLC Patients with Brain Metastases

Hunan Cancer Hospital has launched a Phase 2 clinical trial to evaluate the efficacy and safety of lorlatinib in treating advanced ROS1-positive non-small cell lung cancer (NSCLC) patients with brain metastases. The trial aims to enroll 21 participants from the USA and will assess the intracranial efficacy and safety of lorlatinib. The study seeks to understand the correlation between exploratory biomarkers and lorlatinib resistance, as well as the dynamics of ctDNA in plasma and cerebrospinal fluid (CSF). Participants will receive lorlatinib orally once daily and undergo regular brain imaging and blood sampling for safety and biomarker analysis.

Key Takeaways:

• The clinical trial is a Phase 2, multicenter, open-label, single-arm study evaluating the intracranial efficacy and safety of lorlatinib in adults with TKI-naïve, advanced ROS1-positive NSCLC and untreated brain metastases.
• The trial aims to enroll 21 participants from the USA and will assess the intracranial efficacy and safety of lorlatinib, as well as explore the correlation between exploratory biomarkers and lorlatinib resistance.
• Participants will receive lorlatinib 100 mg orally once daily until disease progression or unacceptable toxicity and undergo regular brain imaging and blood sampling for safety and biomarker analysis.
• The study involves the collection of blood samples for safety/biomarker analysis and optional CSF samples via lumbar puncture during scheduled visits.
• The clinical trial is not yet open for recruiting and is listed on ClinicalTrials.gov under NCT07083687.

Statistics:

• 21 participants from the USA will be enrolled in the clinical trial.
• Participants will receive lorlatinib 100 mg orally once daily until disease progression or unacceptable toxicity.
• Regular brain MRIs/CT scans will be conducted every 8 weeks for the first 12 cycles and every 16 weeks thereafter.
• Blood samples will be collected for safety/biomarker analysis and optional CSF samples via lumbar puncture during scheduled visits.

Sources:

• ClinicalTrials.gov (NCT07083687)