Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02927340
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2016-09-26
Brief Title:
A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official 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 Lesions
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 US 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None