Title: A Phase II Study of Lorlatinib (PF-06463922) in Advanced Anaplastic Lymphoma Kinase (ALK) and ROS Proto-Oncogene 1 (ROS1) Rearranged Non-Small Cell Lung Cancer (NSCLC) With Central Nervous System (CNS) Metastasis in the Absence of Measurable Extracranial Lesions1

Principal Investigator: Alice T. Shaw, MD, PhD, Massachusetts General Hospital

Description: For this open-label, phase 2 study, researchers are assessing the safety and efficacy of lorlatinib — a novel tyrosine kinase inhibitor — among patients with ROS1 and ALK mutation–positive non–small lung cancer (NSCLC) that has metastasized to the central nervous system (CNS).

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Patients will receive oral lorlatinib once daily for 3 week cycles for up to 12 weeks.

The primary outcome is intracranial disease control rate, which will be assessed after 12 weeks. Secondary outcomes include median intracranial progression-free survival (PFS), time to intracranial progression, median intracranial duration of response, median extra-cranial PFS, median overall survival, toxicity assessments, and intracranial objective response rate.

The estimated study enrollment is 30 patients.

For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02927340.

Status: Open and recruiting patients as of November 29, 2017.

This study is sponsored by the Massachusetts General Hospital.


  1. ClinicalTrials.gov. A study of lorlatinib in advanced ALK and ROS1 rearranged lung cancer with CNS metastasis in the absence of measurable extracranial lesions. NCT02927340. https://clinicaltrials.gov/ct2/show/NCT02927340. Accessed November 29, 2017