Recruiting

Biomarker Study

Sponsor:

Tempus AI

Code:

NCT05236114

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observation

Study Details

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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT05236114

Start date

Jun 22, 2022

Status verified date

Feb, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

For Cohort 1 Inclusion, the participant has/is:

  • A known or suspected NSCLC treated with curative intent -(surgery with or without perioperative (neoadjuvant or adjuvant) therapy).

  • Suspected NSCLC - Patients with a high index of suspicion for the diagnosis of NSCLC that is resectable may sign informed consent prior to undergoing diagnostic procedure at the discretion of the physician. NCCN Guidelines allow for clinical stage IA cancers to proceed directly to definitive surgery. Per NCCN Guidelines, if a preoperative tissue diagnosis has not been obtained, then an intraoperative diagnosis will be obtained. If a diagnosis of NSCLC is not confirmed and/or the tumor is not resectable, then the patient will be a screen failure.
  • Undergone or planning to undergo a surgical resection - (Patients with stages I-IIIB who are resectable - per NCCN guidelines of resectability)
  • Both patients who lack molecular abnormalities and those with identified molecular abnormalities may enroll. Choice of perioperative therapy is to follow SOC therapeutic guidelines for the participant's molecular and PD-L1 profile.
  • 18 years old 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 1 Exclusion, the participant has/is:

  • Patients with superior sulcus tumors who are candidates for preoperative concurrent chemoradiation.
  • Stage III locally advanced and unresectable patients who are candidates for chemoradiation followed by immunotherapy.
  • It is expected that all patients on the cohort will be treated with a definitive surgical resection. Thus, clinical stage IIIB and IIIC patients who subsequently demonstrate pathologically confirmed N3 nodal disease or T4 N2 or 3 per any confirmatory procedure listed in NCCN guidelines for which definitive chemoradiotherapy rather than surgery is recommended per NCCN Guidelines are not eligible.
  • Patients who receive primary radiation (in lieu of surgery if they are not surgical candidates).

For Cohort 2 Inclusion, the participant has/is:

  • Histologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy. Palliative radiation (for instance for impending bony fracture or to control pain) is allowed at any time during the protocol at the physician's discretion.
  • Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy). Patients who have had previous exposure to immunotherapy in the neoadjuvant or adjuvant setting are allowed to enroll as long as 12 months have elapsed since the prior exposure.

  • Patients in surveillance on Cohort 1 are eligible to roll over to Cohort 2 at the time of recurrence as long as they have had histologic confirmation of recurrence and have been off immunotherapy for 12 months or greater and meet all other inclusion/exclusion criteria.
  • Tumors that lack activating EGFR mutations (e.g., exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK fusions. Also, per NCCN Guideline recommended testing, tumors must also lack ROS1, BRAF, NTRK 1/2/3, METex14 skipping mutations, and RET for which there is available front-line targeted therapy. Only those patients with KRAS G12C mutations and ERBB2 (HER2) mutations with no contraindications to immunotherapy (PD-L1 1) for which there are no approved front-line targeted therapies and for whom immunotherapy would be the preferred front-line therapy are eligible.
  • Patients may be enrolled with local molecular testing and those results will be provided.

  • Patients may be enrolled with local molecular testing and those results will be provided.
  • 18 years and 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

Exclusion Criteria (both Cohorts):

  • Patients without a known or suspected NSCLC diagnosis, or other disease processes such as sarcoidosis, lymphoma, or metastatic cancer from other sites.
  • Not willing to have additional blood samples collected
  • Patients with a secondary malignancy must have been both diagnosed > 2 years from the lung cancer of interest and have completed all therapy for that malignancy (including extended adjuvant therapy) > 2 years prior to diagnosis of the lung cancer of interest with the exception of the following:
  • Patients with superficial basal cell carcinoma of low-risk histology per NCCN Guidelines (Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus) and low-risk for recurrence per NCCN Guidelines (location on trunk or extremities, size < 2 cm, primary (not recurrent), with well-defined borders) can be included even if they are diagnosed < 2 years from the lung cancer of interest.
  • Patients with superficial squamous cell carcinoma of low-risk pathology per NCCN Guidelines (verrucous, keratoacanthomatous) and low-risk for recurrence per NCCN Guidelines (located on trunk or extremities; 2 cm in size; primary lesion (vs. recurrent); well to moderately differentiated; < 2 mm thick and no invasion beyond subcutaneous fat; negative for perineural invasion; and negative for lymphatic or vascular involvement) can be included even if they are diagnosed < 2 years from the lung cancer of interest.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

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.

Cohort 2

Cohort 2 will include patients with stage IV disease receiving first line immunotherapy (as monotherapy or in combination with chemotherapy).

Interventions

Observation

No intervention

Primary outcome measure

  • Real-World Disease Free Survival (rwDFS) [ Time Frame: 5 years ]
  • Real-World Overall Survival (rwOS) [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

GEMINI NSCLC

(833) 514-4187gemini-nsclc@tempus.com

Locations

Alabama Oncology

Recruiting

Birmingham, Alabama, United States, 35223

Contacts

Amanda Joseph

Amanda.Joseph@AlabamaOncology.com

Principal Investigator:

Mathew Tucker

Mercy Clinic Oncology - Fort Smith

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Billy Cater

Billy.Cater@mercy.net

Principal Investigator:

Aswanth Reddy, MD

MemorialCare

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Tuyet Collucci

562.706.1195TCollucci@memorialcare.org

Principal Investigator:

Amol Rao, MD

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Deanna Romero

310-694-1795DLRomero@mednet.ucla.edu

Principal Investigator:

Amy Cummings

Eastern CT and Hematology and Oncology Associates

Recruiting

Norwich, Connecticut, United States, 06360

Contacts

Susan Johnson

sjohnson@echoct.com

Principal Investigator:

Dennis Slater

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 34711

Contacts

Gopal Kunta

352-242-1366drgkunta@aorcorp.com

Morehouse School of Medicine (MSM)

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

Carla Holloway

404-752-8452cmholloway@msm.edu

Principal Investigator:

Roland Matthews

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Jean Dionne

dionne.jean@piedmont.org

Principal Investigator:

Robert Klafter, MD

Hawaii Cancer Care

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Angelei Pananganan

808-524-6115apanangan@hawaiicancercare.com

Principal Investigator:

David Tamura, MD

Southern Illinois Hospital Services

Recruiting

Carterville, Illinois, United States, 62918

Contacts

Sarmad Nomani

sarmad.nomani@sih.net

Principal Investigator:

Muhammad Popalzai

Cancer Care Specialists of Illinois

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Jade Wiemelt

jwiemelt@ccsci.net

Principal Investigator:

James Wade

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Mira Pasawala

mira.pasawala@northwestern.edu

Hope and Healing Cancer Services

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

Ellen Gustafson

sgustafson@hopenheal.care

Principal Investigator:

Srilata Gundala

OSF Saint Anthony Medical Center

Recruiting

Rockford, Illinois, United States, 61108

Contacts

Shylendra Sreenivasappa

815-227-2859shylendra.b.sreenivasappa2@osfhealthcare.org

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Cindy Stoner

cstoner@ecommunity.com

Principal Investigator:

Natraj Ammakkanavar, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Laura Baptista

319-467-6412laura-batista@uiowa.edu

Principal Investigator:

Muhammad Furqan

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kaylee Martin

Kaylee.Martin@umm.edu

Principal Investigator:

Samuel Rosner, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Cheryl Pai

410-614-1926cpai3@jhmi.edu

Principal Investigator:

Lonny Yarmus, DO

The Center for Cancer and Blood Disorder

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Kosunique Jenkins

kosunique.jenkins@tempus.com

Principal Investigator:

Mark Goldstein, MD

Frederick Health Regional System

Recruiting

Frederick, Maryland, United States, 21702

Contacts

Charity Drummond

cdrummond@frederick.health

Principal Investigator:

Patrick Mansky

Mercy Clinic Oncology and Hematology - Joplin

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Cynthia Meyer

Cynthia.Meyer@mercy.net

Principal Investigator:

Samir Dalia, MD

Lake Regional Health System

Recruiting

Osage Beach, Missouri, United States, 65065

Contacts

Kathy Hirst

khirst@lakeregional.com

Principal Investigator:

Carla Ostronic

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Jennifer Hylton

Jennifer.Hylton@mercy.net

Principal Investigator:

Mohan Tummala, MD

Oncology Hematology Associates

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Adrianna Moore

417-882-4880adrianna.moore@aoncology.com

Principal Investigator:

Robert Ellis, MD

Mercy Clinic Oncology and Hematology - Sindelar Cancer Center

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Laura O'Brien

Laura.OBrien2@mercy.net

Principal Investigator:

Yifan Tu, MD

Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Jessica Black

Jessica.Black@mercy.net

Principal Investigator:

Bethany Sleckman, MD

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Kimberly Wendt

531-444-1230kwendt@nebraskacancer.com

Principal Investigator:

Timothy Huyck, MD

OptumCare Cancer Care

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Danielle Handy

Danielle.handy1@optum.com

Principal Investigator:

Russell Gollard

Hope Cancer Care of Nevada

Recruiting

Las Vegas, Nevada, United States, 89103

Contacts

Mark Gatdula, CRC

702-508-9128Mark.Gatdula@aoncology.com

Principal Investigator:

Raja Mehdi, MD

Cancer Care Specialists Reno

Recruiting

Reno, Nevada, United States, 89511

Contacts

Layla Quinonez

775-329-0222ltapia@ccsreno.com

Principal Investigator:

Juan Adolfo Cattoni III

New Jersey Cancer Center

Recruiting

Belleville, New Jersey, United States, 07109

Contacts

Michael Johnstone

mjohnstone@njcancercare.com

Principal Investigator:

James Orsini Jr.

New York Oncology Hematology

Recruiting

Albany, New York, United States, 12206

Contacts

Josephine Faruol

518-489-0044Josephine.faruol@usoncology.com

Principal Investigator:

Makenzi Evangelist, MD

Hematology Oncology Associates of Central New York

Recruiting

East Syracuse, New York, United States, 13057

Contacts

Nicole Coleman

ncoleman@hoacny.com

Principal Investigator:

Ajeet Gajra

Cayuga Medical Center

Recruiting

Ithaca, New York, United States, 14850

Contacts

Betty Haverlock

607-252-3939bhaverlock@cayugamed.org

Principal Investigator:

Anthony Mato

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Stephanie Chang

stephanie.chang@mssm.edu

Principal Investigator:

Fred Hirsch

White Plains Hospital

Recruiting

White Plains, New York, United States, 10601

Contacts

Madison Gilmore

magilmore@wphospital.org

Principal Investigator:

Dan Costin

UNC

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Ashley Delgado

ashley_delgado@med.unc.edu

Principal Investigator:

Jason Akulian

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Lauren Gray

lauren.gray@duke.edu

Principal Investigator:

Kamran Mahmood, MD

Southeastern Medical Oncology Center (SMOC)

Recruiting

Goldsboro, North Carolina, United States, 27534

Contacts

Jennifer Fields

919-587-9084jfields@cancersmoc.com

Principal Investigator:

Samer Kasbari, MD

Aultman Hospital

Recruiting

Canton, Ohio, United States, 44710

Contacts

Carla Larch

(330)363-1250carla.larch@aultman.com

Principal Investigator:

Raza Khan, MD

TriHealth Cancer Institute

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Wayne Thompson

513-865-5020Wayne_Thompson@trihealth.com

Principal Investigator:

Leanne Budde, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Hazel Antao

Hazel.Antao@osumc.edu

Principal Investigator:

Asrar Alahmadi

OhioHealth Reseach Institute

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Kevin Miller

Kevin.Miller@ohiohealth.com

Principal Investigator:

Arvinder Bhinder, MD

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Jennifer Martinez

jmartinez@toledoclinic.com

Principal Investigator:

John Nemunaitis, MD

Hightower Clinical

Recruiting

Oklahoma City, Oklahoma, United States, 73102

Contacts

Caitlin Merrick

caitlin@hightowerclinical.com

Principal Investigator:

Thy Nguyen, MD

Mercy Clinic Oncology and Hematology - Coletta

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Marian Nolen

Marian.Nolen@mercy.net

Principal Investigator:

Carla Kurkjian, MD

Oklahoma Cancer Specialists and Research Institute

Recruiting

Tulsa, Oklahoma, United States, 74146

Contacts

Stephanie Sandoval

918-505-3200stephanie.sandoval@ocsri.org

Principal Investigator:

Paul Zito, MD

Oregon Oncology Specialists

Recruiting

Salem, Oregon, United States, 97301

Contacts

Cheryl LaBronte

clabronte@orcancer.com

Principal Investigator:

Janelle Meyer, MD

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Jennifer Stough

717-741-9229jstough@cancercareyork.com

Principal Investigator:

Chanh Hyunh, MD

The Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Tyson Kelsey

tysonke@musc.edu

Principal Investigator:

Christopher Gilbert, MD

Baptist Cancer Center

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Angela Gates

901-317-0644angela.gates@tempus.com

Principal Investigator:

Raymond Osarogiagbon, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Ryan Gentzler Principal Investigator

rg2uc@virginia.edu

PeaceHealth St. Joseph Medical Center-Bellingham

Recruiting

Bellingham, Washington, United States, 98225

Contacts

Rebecca Crompton

rcrompton@peacehealth.org

Principal Investigator:

Mervat Saleh, MD

Cancer Care Northwest

Recruiting

Spokane Valley, Washington, United States, 99216

Contacts

Ronaye Wagner

ronaye.wagner@ccnw.net

Principal Investigator:

Dr. Jessica Hellyer, MD

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Rachel Luedtke

920-364-3616Rachel.Luedtke@thedacare.org

Principal Investigator:

Matthias Weiss, MD

Gundersen Health System

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Jennifer Cole

608-775-6694jmcole@gundersenhealth.org

Principal Investigator:

Benjamin Parsons, MD

More Information

Sponsor

Tempus AI

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Cancer
  • Oncology
  • Observational
  • Genomic Profiling
  • Precision medicine
  • Non-Small Cell Lung Cancer
  • NSCLC
  • NGS
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Tempus AI on 2026-02-05.