NCT02927340

A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions

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 Lesions

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a drug as a possible treatment for ALK-positive or ROS1-positive non-small cell lung cancer (NSCLC). The following drug will be involved in this study : * Lorlatinib

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved Lorlatinib as a treatment for any disease. All participants in this study will receive Lorlatinib. Lorlatinib targets the abnormal ALK or ROS1 proteins in NSCLC cells. Lorlatinib has been tested in other research studies and results show that the medicine may help to control the growth of NSCLC even after it has spread to the CNS. The CNS is a term used to refer to the brain and spinal cord, including the lining of the brain and spinal cord which is called the meninges. In this research study, the investigators are trying to determine whether lorlatinib is effective in controlling the growth of cancer cells after they have spread to the CNS. Another purpose of this study is to determine why the cancer cells that have spread to the participant CNS have continued to grow despite treatment with other drugs. For this reason, blood samples will be collected as part of this study to assess the DNA released by the participants cancer cells into their blood when the cells travel to other sites in their body.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Lorlatinib

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-01-01
• Completion: 2023-05-01
• First posted: 2016-10-07
• Last updated: 2021-03-09

Locations

1 site across 1 country: United States