NCT06282874

Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

An Open-label, Single-arm, Multicenter, Prospective Study of Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases.

Detailed description

Fifty eligible subjects will be divided into a BM cohort (brain parenchymal metastasis only) and an LM cohort (leptomeningeal metastasis ± brain parenchymal metastasis). All subjects will receive Lorlatinib 100 mg once daily on days 1 to 28 of each 28-day cycle.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Brain Metastases
• Leptomeningeal Metastasis

Interventions

Type	Name	Description
DRUG	Lorlatinib	Lorlatinib 100 mg once daily on days 1 to 28 of each 28-day cycle

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-04-30
• Completion: 2027-03-01
• First posted: 2024-02-28
• Last updated: 2026-04-09

Locations

3 sites across 1 country: China