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Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers
NCT04712877 · View on ClinicalTrials.gov ↗
Study 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 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 scre
Conditions Studied
Interventions
- DIAGNOSTIC_TEST ctDNA, tumor NGS
Study Locations (20)
California
- University of California, Davis — Davis
- USC Norris Comprehensive Cancer Center — Los Angeles
- UCLA — Los Angeles
- St. Joseph's Hospital Orange — Orange
Massachusetts
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
- Boston Medical Center — Boston
- Dana-Farber Cancer Institute — Boston
Missouri
- University of Missouri — Columbia
- Washington University — St Louis
New York
- NYU — New York
- Columbia University — New York
Florida
- Moffitt Cancer Center — Tampa
Illinois
- Northwestern University — Chicago
Michigan
- University of Michigan — Ann Arbor
New Hampshire
- Dartmouth-Hitchcock — Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2022-06-15 |
| Est. Completion | 2026-06-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04712877
The ClinicalTrials.gov registry entry for NCT04712877 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lung Cancer Mutation Consortium, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with NSCLC appearing as the primary indexed condition, and to 1 intervention — of which ctDNA, tumor NGS is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04712877 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Massachusetts, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04712877 about?
NCT04712877 is a clinical study titled "Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected 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 ...
What is the current status of trial NCT04712877?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2022-06-15. Estimated completion is 2026-06-15.
What conditions does trial NCT04712877 study?
This clinical trial studies the following conditions: NSCLC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04712877?
The interventions under investigation include: ctDNA, tumor NGS (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04712877?
This trial is sponsored by Lung Cancer Mutation Consortium, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04712877 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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