The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04712877
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : September 13, 2023
Sponsor:
Collaborator:
Lung Cancer Research Foundation
Information provided by (Responsible Party):
Scott J. Swanson, Brigham and Women's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer.

The primary purpose of this testing is to determine the presence of 10 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, and HER2, rearrangements in ALK, RET, NTRK, 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.


Condition or disease Intervention/treatment
NSCLC Diagnostic Test: ctDNA, tumor NGS

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers
Actual Study Start Date : June 15, 2022
Estimated Primary Completion Date : June 15, 2024
Estimated Study Completion Date : June 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Diagnostic Test: ctDNA, tumor NGS
    Testing for actionable oncogenic drivers
    Other Names:
    • FoundationOne CDx
    • FoundationOne Liquid

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of Patients who Possess Actionable Oncogenic Drivers [ Time Frame: 8 weeks ]
    The primary outcome measure is the determination of the proportion of patients with stage IA2-III lung cancers who possess actionable oncogenic drivers. A patient is considered to have a actionable oncogenic driver if they have any of the following 10 genomic alterations: ALK rearrangements, BRAFV600E mutations, EGFR sensitizing mutations, HER2 mutation, HER2 amplification, MET amplification, MET exon 14 mutation, RET rearrangements, NTRK rearrangement, or ROS1 rearrangements.


Secondary Outcome Measures :
  1. Tumor Mutation Burden (TMB) Assessment [ Time Frame: 8 weeks ]
    Measure TMB in all patient tumor samples (Mutations per megabase)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The LCMC LEADER screening trial will enroll all patients with clinically suspected, resectable stage I-III lung cancers. The population of interest is patients with resectable non-squamous non-small cell lung cancer, however a histologic diagnosis is not required at the time of study enrollment. We anticipate a small portion of patients with squamous cell and non-NSCLC histologies to be genotyped centrally in parallel to their histologic diagnosis. Only patients with non-small cell lung cancers that are not purely squamous will be counted towards the primary study endpoint.
Criteria

Inclusion Criteria:

  • Clinical stage IA2-III lung cancers
  • Potentially resectable if lung cancer suspicion confirmed pathologically
  • Operable

Exclusion Criteria:

  • No concurrent malignancy
  • No prior lung cancer within last 2 years
  • Purely ground glass pulmonary opacity
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT04712877


Contacts
Layout table for location contacts
Contact: Christian Brodala, BBA 646-608-2838 brodalac@mskcc.org

Locations
Layout table for location information
United States, California
University of California, Davis Recruiting
Davis, California, United States, 95616
Contact: Ashley Dang-Chu       ldangchu@ucdavis.edu   
Principal Investigator: Tianhong Li, MD, PhD         
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Peggy Romano       peggy.romano@med.usc.edu   
Principal Investigator: Sean Wightman, MD         
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Rubi Arias       rubiarias@mednet.ucla.edu   
Principal Investigator: Jay Lee, MD         
St. Joseph's Hospital Orange Recruiting
Orange, California, United States, 92868
Contact: Ron Bati       Ron.Bati@stjoe.org   
Principal Investigator: John Maurice, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Isha Mehta Warikoo       imehtawarikoo@mgh.harvard.edu   
Principal Investigator: Michael Lanuti, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kristina Sidopoulos       ksidopoulos@bwh.harvard.edu   
Principal Investigator: Hisashi Tsukada, MD, PhD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jennifer Luu       jennifer_luu@dfci.harvard.edu   
Principal Investigator: Bruce E Johnson, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shari Barnett       shbailey@med.umich.edu   
Principal Investigator: Jules Lin, MD         
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Brooke McDaniel       mcdanielbl@health.missouri.edu   
Principal Investigator: Jussuf Kaifi, MD         
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Aleksis Cotton       a.cotton@wustl.edu   
Principal Investigator: Saiama Waqar, MBBS, MSCI         
United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Kristina Wiley       Kristina.M.Willey@hitchcock.org   
Principal Investigator: David Finley, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jessica Shealor       shealorj@musc.edu   
Principal Investigator: Ian Bostock, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Michelle Almarez       michelle.almarez@bcm.edu   
Principal Investigator: Taylor Ripley, MD         
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Brian Phipps       Brian.phipps@usoncology.com   
Principal Investigator: Alexander Spira, MD, PhD, FACP         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98019
Contact: Lara Schiff       lschiff1@seattlecca.org   
Principal Investigator: Christina Baik, MD, MPH         
Sponsors and Collaborators
Lung Cancer Mutation Consortium
Lung Cancer Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Scott J Swanson, MD Brigham and Women's Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: 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, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04712877    
Other Study ID Numbers: LCMC LEADER
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No