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 : Unknown
Verified January 2021 by Ibiayi Dagogo-Jack, M.D., Massachusetts General Hospital.
Recruitment status was: Recruiting
First Posted : October 7, 2016
Last Update Posted : March 9, 2021
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Tracking Information | ||||
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First Submitted Date ICMJE | September 26, 2016 | |||
First Posted Date ICMJE | October 7, 2016 | |||
Last Update Posted Date | March 9, 2021 | |||
Study Start Date ICMJE | October 2016 | |||
Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions | |||
Official Title ICMJE | 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 | |||
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 :
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer (NSCLC) | |||
Intervention ICMJE | Drug: Lorlatinib | |||
Study Arms ICMJE | Experimental: Lorlatinib
Lorlatinib will be administered orally once daily on a 21 day cycle Blood will be collected for biomarker studies
Intervention: Drug: Lorlatinib
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Publications * | Dagogo-Jack I, Oxnard GR, Evangelist M, Digumarthy SR, Lin JJ, Gainor JF, Murphy JF, Rabin MS, Heist RS, Muzikansky A, Shaw AT. Phase II Study of Lorlatinib in Patients With Anaplastic Lymphoma Kinase-Positive Lung Cancer and CNS-Specific Relapse. JCO Precis Oncol. 2022 May;6:e2100522. doi: 10.1200/PO.21.00522. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | May 2023 | |||
Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02927340 | |||
Other Study ID Numbers ICMJE | 16-248 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Ibiayi Dagogo-Jack, M.D., Massachusetts General Hospital | |||
Original Responsible Party | Alice Shaw, Massachusetts General Hospital, MD, PhD | |||
Current Study Sponsor ICMJE | Massachusetts General Hospital | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |