A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions
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|ClinicalTrials.gov Identifier: NCT02927340|
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : August 2, 2019
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 :
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer (NSCLC)||Drug: Lorlatinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2023|
Lorlatinib will be administered orally once daily on a 21 day cycle Blood will be collected for biomarker studies
- Intracranial Disease Control Rate (DCR) [ Time Frame: 12 weeks ]DCR will be calculated at 12 weeks based on response assessments in the brain for patients with measurable CNS disease
- Median intracranial Progression-Free Survival (PFS) [ Time Frame: 2 years ]
- Time to intracranial (IC) progression [ Time Frame: 2 years ]
- Median Intracranial Duration of Response (DOR) [ Time Frame: 2 years ]The distribution function of DOR will be estimated using the Kaplan-Meier method
- Median extra-cranial PFS [ Time Frame: 2 years ]Extra-cranial PFS will be defined as the time from the start of study drug treatment to the date of the first documented progression at an extra-cranial site or death. The distribution of PFS will be estimated using the Kaplan-Meier method.
- Median Overall Survival [ Time Frame: 2 years ]
- Toxicity assessed using CTCAE v4.0 criteria [ Time Frame: 2 years ]
- Intracranial Objective Response Rate (ORR) [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927340
|Contact: Alice T Shaw, MD, PhD||617-724-4000|
|United States, Massachusetts|
|Massachusetts general Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Alice T Shaw, MD, PhD 617-724-4000|
|Principal Investigator: Alice T Shaw, MD, PhD|
|Principal Investigator:||Alice T Shaw, MD, PhD||Massachusetts General Hospital|