GEMINI-NSCLC: NSCLC Biomarker Study
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Other: Observation
- Registration Number
- NCT05236114
- Lead Sponsor
- Tempus AI
- Brief Summary
GEMINI NSCLC Study is a non-interventional study that will be collecting clinical and molecular health information from patients with NSCLC who will receive longitudinal blood collection in addition to their standard of care therapy and disease surveillance with the goals of identifying the molecular evolution of lung cancer with standard of care therapy, and determining the utility of ctDNA dynamics to predict risk of recurrence and therapeutic outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 2 Observation Cohort 2 will include patients with stage IV disease receiving first line immunotherapy (as monotherapy or in combination with chemotherapy). Cohort 1 Observation Cohort 1 will include patients with early-stage (Stages I-IIIB) who are candidates for treatment with curative intent, surgery with or without perioperative (neoadjuvant or adjuvant) therapy.
- Primary Outcome Measures
Name Time Method Real-World Disease Free Survival (rwDFS) 5 years Real-World Overall Survival (rwOS) 3 years
- Secondary Outcome Measures
Name Time Method Positive percent agreement and negative percent agreement between plasma ctDNA vs tumor tissue at benchmark & longitudinal time points 5 years Real-World Overall Survival 18 months Treatment patterns 18 months Real-World Disease Free Survival (rwDFS) stratified by ctDNA status at benchmark 5 years Sensitivity, Specificity, PPV and NPV of MRD assay to predict recurrence at benchmark vs physician assessment of recurrence via conventional imaging every 6 months 5 years Real-World Overall Survival (rwOS) stratified by ctDNA status at benchmark 5 years pCR rate stratified by ctDNA status 5 years Sensitivity, Specificity, PPV and NPV of MRD assay to predict recurrence across longitudinal collections vs physician assessment of recurrence via conventional imaging every 6 months 5 years Positive percent agreement and negative percent agreement between plasma ctDNA vs. tumor tissue at benchmark & longitudinal time points 18 months Real-World Progression-Free 18 months
Trial Locations
- Locations (49)
Frederick Health Regional System
🇺🇸Frederick, Maryland, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Mercy Clinic Oncology - Fort Smith
🇺🇸Fort Smith, Arkansas, United States
MemorialCare
🇺🇸Fountain Valley, California, United States
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
Eastern CT and Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Woodlands Medical Specialists
🇺🇸Pensacola, Florida, United States
Morehouse School of Medicine (MSM)
🇺🇸Atlanta, Georgia, United States
Hawaii Cancer Care
🇺🇸Honolulu, Hawaii, United States
Southern Illinois Hospital Services
🇺🇸Carterville, Illinois, United States
Cancer Care Specialists of Illinois
🇺🇸Decatur, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Hope and Healing Cancer Services
🇺🇸Hinsdale, Illinois, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
The Center for Cancer and Blood Disorder
🇺🇸Bethesda, Maryland, United States
Mercy Clinic Oncology and Hematology - Joplin
🇺🇸Joplin, Missouri, United States
Lake Regional Health System
🇺🇸Osage Beach, Missouri, United States
Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
🇺🇸Springfield, Missouri, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
OptumCare Cancer Care
🇺🇸Las Vegas, Nevada, United States
Hope Cancer Care of Nevada
🇺🇸Las Vegas, Nevada, United States
New Jersey Cancer Center
🇺🇸Belleville, New Jersey, United States
New York Oncology Hematology
🇺🇸Albany, New York, United States
Hematology Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
Cayuga Medical Center
🇺🇸Ithaca, New York, United States
UNC
🇺🇸Chapel Hill, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Southeastern Medical Oncology Center (SMOC)
🇺🇸Goldsboro, North Carolina, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
TriHealth Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
OhioHealth Reseach Institute
🇺🇸Columbus, Ohio, United States
Taylor Cancer Research Center
🇺🇸Maumee, Ohio, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
Mercy Clinic Oncology and Hematology - Coletta
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute
🇺🇸Tulsa, Oklahoma, United States
Oregon Oncology Specialists
🇺🇸Salem, Oregon, United States
Cancer Care Associates of York
🇺🇸York, Pennsylvania, United States
The Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
PeaceHealth St. Joseph Medical Center-Bellingham
🇺🇸Bellingham, Washington, United States
Gundersen Health System
🇺🇸La Crosse, Wisconsin, United States