Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers
NCT ID: NCT04712877
Last Updated: 2024-07-17
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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RECRUITING
1000 participants
OBSERVATIONAL
2022-06-15
2026-06-15
Brief Summary
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The primary purpose of this testing is to determine the presence of 12 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, KRAS G12C and HER2, rearrangements in ALK, RET, NTRK, EGFR exon 20 insertion and ROS1, and amplification of MET and HER2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected.
Thoracic Surgery Oncology Group (TSOG) is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer. TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial. TSOG's involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study. We estimate we will detect an actionable oncogenic driver in 33% of cases. The remaining 66% of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents.
The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial, evaluating for efficacy. If none of the 10 oncogenic drivers are detected, the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy. For patients not enrolled on a targeted treatment trial, circulating tumor DNA in blood (ctDNA) will be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. This initiative will be correlated with various clinical outcomes. Prespecified clinical data will be collected for correlation with these circulating biomarkers.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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ctDNA, tumor NGS
Testing for actionable oncogenic drivers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Potentially resectable if lung cancer suspicion confirmed pathologically
* Operable
Exclusion Criteria
* No prior lung cancer within last 2 years
* Purely ground glass pulmonary opacity
ALL
No
Sponsors
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Lung Cancer Research Foundation
OTHER
Lung Cancer Mutation Consortium
NETWORK
Responsible Party
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Scott J. Swanson
Canepari Family Distinguished Chair in Thoracic Surgery, Director of Minimally Invasive Thoracic Surgery and Clinical Director of Thoracic Surgery, BWH, Associate Chief of Surgery, DFCI, Professor of Surgery, Harvard Medical School
Principal Investigators
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Scott J Swanson, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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University of California, Davis
Davis, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
St. Joseph's Hospital Orange
Orange, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Missouri
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
NYU
New York, New York, United States
Columbia University
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LCMC LEADER
Identifier Type: -
Identifier Source: org_study_id
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