Actively Recruiting
GEMINI-NSCLC: NSCLC Biomarker Study
Led by Tempus AI ยท Updated on 2026-02-05
1200
Participants Needed
58
Research Sites
362 weeks
Total Duration
On this page
Sponsors
T
Tempus AI
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GEMINI-NSCLC: NSCLC Biomarker Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Known or suspected NSCLC treated with curative intent including surgery with or without perioperative therapy
- Suspected NSCLC patients with high suspicion for resectable disease may consent before diagnostic procedures
- Undergone or planning surgical resection for stages I-IIIB resectable NSCLC
- Patients with or without molecular abnormalities may enroll; perioperative therapy follows standard guidelines
- 18 years old or older
- Willing and able to provide informed consent
- Willing to provide additional blood samples during routine surveillance
- Must submit tumor sample representative of current disease
- Histologically documented Stage IV NSCLC not amenable to curative surgery or radiation
- Intended to receive first-line immunotherapy (alone or with chemotherapy); prior immunotherapy allowed if at least 12 months since last exposure
- Surveillance patients from Cohort 1 with confirmed recurrence and off immunotherapy for 12+ months may join Cohort 2
- Tumors must lack certain activating mutations with available targeted therapies except KRAS G12C and ERBB2 mutations
- Local molecular testing results acceptable and must be provided
You will not qualify if you...
- Patients with superior sulcus tumors eligible for preoperative concurrent chemoradiation
- Stage III locally advanced unresectable patients recommended for chemoradiation and immunotherapy instead of surgery
- Clinical stage IIIB and IIIC patients with pathologically confirmed nodal disease requiring definitive chemoradiotherapy rather than surgery
- Patients receiving primary radiation instead of surgery if not surgical candidates
- Patients without known or suspected NSCLC diagnosis or with other diseases like sarcoidosis, lymphoma, or metastatic cancer from other sites
- Not willing to provide additional blood samples
- Patients with secondary malignancy diagnosed within 2 years of lung cancer or who have not completed therapy for that malignancy, except certain low-risk superficial skin cancers per guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
G
GEMINI NSCLC
CONTACT
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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