Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers
Key facts
- Who runs it
- Lung Cancer Mutation Consortium
- Where
- Ann Arbor, Boston, Charleston, Chicago, Columbia, Columbus, Davis, Fairfax, Hartford, Houston, Lebanon, Los Angeles, New York, Orange, Portland, Seattle, St Louis, Stanford, and Tampa, United StatesSee the 25 sites
- Trial code
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 15 Jun 2022
- Expected to end
- 31 Dec 2027
- Type of study
- Observational
- Treatments tested
- ctDNA, tumor NGS
- Record updated
- 12 November 2026
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Clinical stage IA2-III lung cancers
- Potentially resectable if lung cancer suspicion confirmed pathologically
- Operable
Who cannot take part
- No concurrent malignancy
- No prior lung cancer within last 2 years
- Purely ground glass pulmonary opacity
Where in United States
- University of MichiganAnn Arbor, United StatesContact: Shari BarnettTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesContact: Christine ConleyTaking people
- Boston Medical CenterBoston, United StatesContact: Anthony SheltonTaking people
- Brigham and Women's HospitalBoston, United StatesContact: Kristina SidopoulosTaking people
- Dana-Farber Cancer InstituteBoston, United StatesContact: Jennifer LuuTaking people
- Massachusetts General HospitalBoston, United StatesContact: Isha Mehta WarikooTaking people
- Medical University of South CarolinaCharleston, United StatesContact: Jessica ShealorTaking people
- Northwestern UniversityChicago, United StatesContact: RHLCCC Trial TeamTaking people
- University of MissouriColumbia, United StatesContact: Brooke McDanielTaking people
- Ohio State UniversityColumbus, United StatesContact: Helena GastierTaking people
- University of California, DavisDavis, United StatesContact: Christian Brodala, BBANo longer taking part
- Virginia Cancer Specialists PCFairfax, United StatesContact: Brian PhippsTaking people
- Hartford HealthcareHartford, United StatesContact: Lorin CamposTaking people
- Baylor College of MedicineHouston, United StatesContact: Michelle AlmarezTaking people
- Dartmouth HitchcockLebanon, United StatesContact: Kristina WileyTaking people
- UCLALos Angeles, United StatesContact: Christian Brodala, BBANo longer taking part
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesContact: Christian Brodala, BBANo longer taking part
- NYUNew York, United StatesContact: Nadia CattiTaking people
- Columbia UniversityNew York, United StatesContact: Christian Brodala, BBANo longer taking part
- St. Joseph's Hospital OrangeOrange, United StatesContact: Ron BatiTaking people
- Providence PortlandPortland, United StatesContact: Brenda FisherTaking people
- University of WashingtonSeattle, United StatesContact: Lara SchiffTaking people
- Washington UniversitySt Louis, United StatesContact: Christian Brodala, BBANo longer taking part
- Stanford UniversityStanford, United StatesContact: Debbie BajomoTaking people
- Moffitt Cancer CenterTampa, United StatesContact: Tara AckermanTaking people
About the trial
What the trial wants to find out
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.
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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.
Treatments tested
- ctDNA, tumor NGS
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers
- Record updated
- 12 November 2026