Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
945 participants
INTERVENTIONAL
2019-12-13
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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All-Comer Cohort
Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.
Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.
Front-line Immunotherapy Re-enrollment Cohort
Participants with mNSCLC or ES-SCLC that have received front-line treatment as defined by the protocol will give blood samples at three separate timepoints for ctDNA profiling.
Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.
Interventions
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Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.
Eligibility Criteria
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Inclusion Criteria
* Planned initiation of SOC systemic anti-cancer treatment
* Front-Line Immunotherapy Cohort: Received front-line treatment of an immune blockade therapy including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody on Protocol GX41563
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Flatiron Health, Inc.; Foundation Medicine, Inc.
UNKNOWN
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alabama Oncology
Birmingham, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Yale University
New Haven, Connecticut, United States
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, United States
SCRI Florida Cancer Specialists PAN
Tallahassee, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
University Cancer & Blood Center, LLC; Research
Athens, Georgia, United States
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States
Fort Wayne Med Oncology & Hematology Inc
Fort Wayne, Indiana, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States
Southeast Nebraska Cancer Ctr
Lincoln, Nebraska, United States
Regional Cancer Care Associates LLC, Central Jersey Division
East Brunswick, New Jersey, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States
West Clinic
New York, New York, United States
National Translational Research Group
Port Jefferson Station, New York, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States
Virginia Cancer Institute - Richmond
Richmond, Virginia, United States
Countries
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Other Identifiers
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GX41563
Identifier Type: -
Identifier Source: org_study_id
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