Actively Recruiting

Age: 18Years +
All Genders
NCT05236114

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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