Cancer statistics, 2020.
Rebecca L Siegel, Kimberly D Miller, Ahmedin Jemal
https://pubmed.ncbi.nlm.nih.gov/31912902Actively Recruiting
Age: 18Years +
All Genders
ID05236114
TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)
Led by Tempus AI · Updated on 2026-02-05
1200
Participants Needed
58
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tempus AI
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with non-small cell lung cancer (NSCLC) to better understand how the cancer changes on a molecular level during standard treatments. The study aims to track the disease's progress and explore how changes in circulating tumor DNA (ctDNA) might predict cancer recurrence and treatment outcomes. This observational study collects clinical and molecular health data over time from patients receiving usual care. The study involves two groups of patients. The first group includes patients with early-stage NSCLC (Stages I to IIIB) who are treated with surgery and possibly additional therapies before or after surgery. The second group includes patients with advanced stage IV NSCLC receiving first-line immunotherapy, either alone or combined with chemotherapy. Patients will provide blood samples regularly during their routine care to help researchers analyze ctDNA and its changes over time. Participants will be asked to provide tumor samples and give additional blood samples during standard surveillance visits. Researchers will monitor disease-free survival and overall survival over periods up to five years. They will also compare ctDNA testing results with traditional imaging methods used every six months to detect cancer recurrence. The study tracks various outcomes, including treatment patterns and progression-free survival, to gain a detailed understanding of how the disease evolves under standard care.
CONDITIONS
Brief Title
GEMINI-NSCLC: NSCLC Biomarker Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- For Cohort 1: Known or suspected NSCLC treated with curative intent by surgery with or without perioperative therapy
- Patients with stages I to IIIB who are candidates for surgical resection
- Patients 18 years or older
- Willing and able to provide informed consent
- Willing to have additional blood samples collected during routine surveillance visits
- Must submit tumor sample representative of current disease
- For Cohort 2: Histologically confirmed stage IV NSCLC not suitable for curative surgery or radiation
- Intended to receive first-line immunotherapy (alone or with chemotherapy)
- Prior immunotherapy allowed if at least 12 months have passed
- 18 years or older
- Willing and able to provide informed consent
- Willing to have additional blood samples collected during routine surveillance visits
- Must submit tumor sample representative of current disease
You will not qualify if you...
- Patients with superior sulcus tumors candidates for preoperative chemoradiation
- Patients with stage III locally advanced unresectable disease recommended for chemoradiation and immunotherapy
- Patients with stage IIIB or IIIC disease with confirmed N3 nodal disease or T4 N2 or N3 not eligible for surgery
- Patients receiving primary radiation instead of surgery if not surgical candidates
- Patients without known or suspected NSCLC diagnosis or with other diseases such as sarcoidosis, lymphoma, or metastatic cancer from other sites
- Not willing to provide additional blood samples
- Patients with secondary malignancy diagnosed within 2 years or receiving therapy within 2 years, except low-risk basal cell or squamous cell carcinoma as defined by guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - Up to 5 years
Participants who undergo routine care are observed with additional blood samples collected during routine surveillance visits.
Visits approximately every 6 months for imaging and blood sample collection
Trial Site Locations
Total: 58 locations
1
Alabama Oncology
Birmingham, Alabama, United States, 35223
Actively Recruiting
2
Mercy Clinic Oncology - Fort Smith
Fort Smith, Arkansas, United States, 72903
Actively Recruiting
3
MemorialCare
Fountain Valley, California, United States, 92708
Actively Recruiting
4
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
Active, Not Recruiting
5
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
6
Eastern CT and Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Actively Recruiting
7
Clermont Oncology Center
Clermont, Florida, United States, 34711
Actively Recruiting
8
Woodlands Medical Specialists
Pensacola, Florida, United States, 32503
Withdrawn
9
Morehouse School of Medicine (MSM)
Atlanta, Georgia, United States, 30310
Actively Recruiting
10
Piedmont Healthcare
Atlanta, Georgia, United States, 30318
Actively Recruiting
11
Hawaii Cancer Care
Honolulu, Hawaii, United States, 96813
Actively Recruiting
12
Southern Illinois Hospital Services
Carterville, Illinois, United States, 62918
Actively Recruiting
13
Cancer Care Specialists of Illinois
Decatur, Illinois, United States, 62526
Actively Recruiting
14
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
15
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Actively Recruiting
16
OSF Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
Actively Recruiting
17
Community Health Network
Indianapolis, Indiana, United States, 46250
Actively Recruiting
18
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
19
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
20
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
21
The Center for Cancer and Blood Disorder
Bethesda, Maryland, United States, 20817
Actively Recruiting
22
Frederick Health Regional System
Frederick, Maryland, United States, 21702
Actively Recruiting
23
Mercy Clinic Oncology and Hematology - Joplin
Joplin, Missouri, United States, 64804
Actively Recruiting
24
Lake Regional Health System
Osage Beach, Missouri, United States, 65065
Actively Recruiting
25
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
Springfield, Missouri, United States, 65804
Actively Recruiting
26
Oncology Hematology Associates
Springfield, Missouri, United States, 65807
Actively Recruiting
27
Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
St Louis, Missouri, United States, 63128
Actively Recruiting
28
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
St Louis, Missouri, United States, 63141
Actively Recruiting
29
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
30
OptumCare Cancer Care
Las Vegas, Nevada, United States, 89102
Actively Recruiting
31
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States, 89103
Actively Recruiting
32
Cancer Care Specialists Reno
Reno, Nevada, United States, 89511
Actively Recruiting
33
New Jersey Cancer Center
Belleville, New Jersey, United States, 07109
Actively Recruiting
34
New York Oncology Hematology
Albany, New York, United States, 12206
Actively Recruiting
35
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Actively Recruiting
36
Cayuga Medical Center
Ithaca, New York, United States, 14850
Actively Recruiting
37
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
38
White Plains Hospital
White Plains, New York, United States, 10601
Actively Recruiting
39
UNC
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
40
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
41
Southeastern Medical Oncology Center (SMOC)
Goldsboro, North Carolina, United States, 27534
Actively Recruiting
42
Aultman Hospital
Canton, Ohio, United States, 44710
Actively Recruiting
43
TriHealth Cancer Institute
Cincinnati, Ohio, United States, 45220
Actively Recruiting
44
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
45
OhioHealth Reseach Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
46
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
47
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73102
Actively Recruiting
48
Mercy Clinic Oncology and Hematology - Coletta
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
49
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
50
Oregon Oncology Specialists
Salem, Oregon, United States, 97301
Actively Recruiting
51
Cancer Care Associates of York
York, Pennsylvania, United States, 17403
Actively Recruiting
52
The Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
53
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Actively Recruiting
54
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
55
PeaceHealth St. Joseph Medical Center-Bellingham
Bellingham, Washington, United States, 98225
Actively Recruiting
56
Cancer Care Northwest
Spokane Valley, Washington, United States, 99216
Actively Recruiting
57
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States, 54911
Actively Recruiting
58
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
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Research Team
G
GEMINI NSCLC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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