Testing tumor tissue and blood for personalized treatments in suspected lung cancer patients
LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers
This study is testing if analyzing tumor samples and blood from patients with suspected early-stage lung cancer can help find the best personalized treatment options for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Lung Cancer Mutation Consortium Research network |
| Drugs / interventions | atezolizumab, durvalumab, nivolumab, pembrolizumab |
| Locations | 21 sites (Davis, California and 20 other locations) |
| Trial ID | NCT04712877 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of comprehensive molecular profiling in patients with suspected early-stage non-small cell lung cancer (NSCLC) who are scheduled for biopsies. The study focuses on identifying 12 specific oncogenic drivers that could make patients eligible for targeted neoadjuvant therapy trials. By analyzing tumor tissue and circulating tumor DNA (ctDNA), the goal is to select the most appropriate neoadjuvant therapy based on the molecular characteristics of the cancer. This approach seeks to enhance treatment personalization and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with clinical stage IA2-III lung cancers who are potentially resectable and operable.
Not a fit: Patients with concurrent malignancies, prior lung cancer within the last 2 years, or purely ground glass pulmonary opacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective personalized treatment options for patients with lung cancer.
How similar studies have performed: Other studies have shown promise in using molecular profiling for targeted therapies in lung cancer, indicating that this approach is supported by prior successes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Davis, California and 20 other locations
- University of California, Davis — Davis, California, United States (Recruiting)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- UCLA — Los Angeles, California, United States (Recruiting)
- St. Joseph's Hospital Orange — Orange, California, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Missouri — Columbia, Missouri, United States (Recruiting)
- Washington University — St Louis, Missouri, United States (Recruiting)
- Dartmouth-Hitchcock — Lebanon, New Hampshire, United States (Recruiting)
- NYU — New York, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- Virginia Cancer Specialists, PC — Fairfax, Virginia, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Scott J Swanson, MD — Brigham and Women's Hospital
- Study coordinator: Christian Brodala, BBA
- Email: brodalac@mskcc.org
- Phone: 646-608-2838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.