NSCLCNCT04712877
Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers
An observational study of NSCLC, run by Lung Cancer Mutation Consortium at 21 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC
- What is being tested?
- ctDNA, tumor NGS
- How many people
- 1,000 participants
- Where
- 21 sitesUnited States
- Study dates
- 15 Jun 2022to 15 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical stage IA2-III lung cancers
- Potentially resectable if lung cancer suspicion confirmed pathologically
- Operable
Who cannot join
- No concurrent malignancy
- No prior lung cancer within last 2 years
- Purely ground glass pulmonary opacity
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites, 21 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Shari Barnett, shbailey@med.umich.edu
Jules Lin, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Isha Mehta Warikoo, imehtawarikoo@mgh.harvard.edu
Michael Lanuti, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kristina Sidopoulos, ksidopoulos@bwh.harvard.edu
Hisashi Tsukada, MD, PhD
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Anthony Shelton, anthony.shelton@bmc.org
Umit Tapan, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Jennifer Luu, jennifer_luu@dfci.harvard.edu
Bruce E Johnson, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Jessica Shealor, shealorj@musc.edu
Ian Bostock, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
RHLCCC Trial Team, RHLCCCTrialStartup@northwestern.edu
Jyoti Patel, MD
- Recruiting
University of Missouri
Columbia, Missouri, 65212
Brooke McDaniel, mcdanielbl@health.missouri.edu
Jussuf Kaifi, MD
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Helena Gastier, Helena.gastier@osumc.edu
Desmond D'Souza, MD
- Recruiting
University of California, Davis
Davis, California, 95616
Ashley Dang-Chu, ldangchu@ucdavis.edu
Tianhong Li, MD, PhD
- Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Brian Phipps, Brian.phipps@usoncology.com
Alexander Spira, MD, PhD, FACP
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Michelle Almarez, michelle.almarez@bcm.edu
Taylor Ripley, MD
- Recruiting
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
Kristina Wiley, Kristina.M.Willey@hitchcock.org
David Finley, MD
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Peggy Romano, peggy.romano@med.usc.edu
Sean Wightman, MD
- Recruiting
UCLA
Los Angeles, California, 90095
Rubi Arias, rubiarias@mednet.ucla.edu
Jay Lee, MD
- Recruiting
NYU
New York, New York, 10016
Nadia Catti, nadia.catti@nyulangone.org
Elaine Shum, MD
- Recruiting
Columbia University
New York, New York, 10032
Angela Foligno, af3273@cumc.columbia.edu
Catherine Shu, MD
- Recruiting
St. Joseph's Hospital Orange
Orange, California, 92868
Ron Bati, Ron.Bati@stjoe.org
Tiimothy Byun, MD
- Recruiting
University of Washington
Seattle, Washington, 98019
Lara Schiff, lschiff1@seattlecca.org
Christina Baik, MD, MPH
- Recruiting
Washington University
St Louis, Missouri, 63110
Aleksis Cotton, a.cotton@wustl.edu
Saiama Waqar, MBBS, MSCI
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Tara Ackerman, Tara.Ackerman@moffitt.org
Andreas Saltos, MD
About this study
Official title: LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers
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 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.
Read more
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.
- Conditions
- NSCLC
- Being tested
- ctDNA, tumor NGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA, tumor NGSDiagnostic test
Also called FoundationOne CDx, FoundationOne Liquid
Testing for actionable oncogenic drivers
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients who Possess Actionable Oncogenic Drivers
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.
Measured: 8 weeks
Secondary outcomes (1)
Tumor Mutation Burden (TMB) Assessment
Measure TMB in all patient tumor samples (Mutations per megabase)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start15 Jun 2022
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lung Cancer Mutation Consortium
- Sponsor type
- Research network
- Collaborators
- Lung Cancer Research Foundation
- Responsible party
- Principal investigator, Scott J. Swanson, Brigham and Women's Hospital
- Investigators
- Scott J Swanson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712877
- Sponsor's protocol ID
- LCMC LEADER
- Status last verified
- Jul 2024
- First submitted
- 16 Oct 2020
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers
- ClinicalTrials.gov ID
- NCT04712877
- Acronym / sponsor ID
- LCMC LEADER
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lung Cancer Mutation ConsortiumResearch network
- Collaborators
- Lung Cancer Research Foundation
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Clinical stage IA2-III lung cancers
- Potentially resectable if lung cancer suspicion confirmed pathologically
- Operable
Key exclusion criteria (3 listed)
- No concurrent malignancy
- No prior lung cancer within last 2 years
- Purely ground glass pulmonary opacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ctDNA, tumor NGSAlso: FoundationOne CDx, FoundationOne LiquidTesting for actionable oncogenic drivers | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Tumor Mutation Burden (TMB) Assessment
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott J Swanson, MD principal investigator
Brigham and Women's Hospital
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Lung Cancer Mutation Consortium at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Brodala, BBA (646-608-2838, brodalac@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients who Possess Actionable Oncogenic Drivers (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.