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RecruitingObservational

TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT05236114Sponsor: Tempus AILast updated: 2026-02-05

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.

Arms & interventions

  • OtherObservation

    No intervention

Outcome measures

Primary

  • Real-World Disease Free Survival (rwDFS)

    Time frame: 5 years

  • Real-World Overall Survival (rwOS)

    Time frame: 3 years

Secondary

  • Sensitivity, Specificity, PPV and NPV of MRD assay to predict recurrence at benchmark vs physician assessment of recurrence via conventional imaging every 6 months

    Time frame: 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

    Time frame: 5 years

  • Real-World Disease Free Survival (rwDFS) stratified by ctDNA status at benchmark

    Time frame: 5 years

  • pCR rate stratified by ctDNA status

    Time frame: 5 years

  • Real-World Overall Survival (rwOS) stratified by ctDNA status at benchmark

    Time frame: 5 years

  • Positive percent agreement and negative percent agreement between plasma ctDNA vs tumor tissue at benchmark & longitudinal time points

    Time frame: 5 years

  • Real-World Overall Survival

    Time frame: 18 months

  • Real-World Progression-Free

    Time frame: 18 months

  • Treatment patterns

    Time frame: 18 months

  • Positive percent agreement and negative percent agreement between plasma ctDNA vs. tumor tissue at benchmark & longitudinal time points

    Time frame: 18 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (58)

Alabama Oncology

Birmingham, Alabama, 35223

Recruiting
Amanda Joseph · Contact
Amanda.Joseph@AlabamaOncology.com
Mathew Tucker · Principal Investigator

Mercy Clinic Oncology - Fort Smith

Fort Smith, Arkansas, 72903

Recruiting
Billy Cater · Contact
Billy.Cater@mercy.net
Aswanth Reddy, MD · Principal Investigator

MemorialCare

Fountain Valley, California, 92708

Recruiting
Tuyet Collucci · Contact
562.706.1195TCollucci@memorialcare.org
Amol Rao, MD · Principal Investigator

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720

Active Not Recruiting

UCLA

Los Angeles, California, 90095

Recruiting
Deanna Romero · Contact
310-694-1795DLRomero@mednet.ucla.edu
Amy Cummings · Principal Investigator

Eastern CT and Hematology and Oncology Associates

Norwich, Connecticut, 06360

Recruiting
Susan Johnson · Contact
sjohnson@echoct.com
Dennis Slater · Principal Investigator

Clermont Oncology Center

Clermont, Florida, 34711

Recruiting
Gopal Kunta · Contact
352-242-1366drgkunta@aorcorp.com

Woodlands Medical Specialists

Pensacola, Florida, 32503

Withdrawn

Morehouse School of Medicine (MSM)

Atlanta, Georgia, 30310

Recruiting
Carla Holloway · Contact
404-752-8452cmholloway@msm.edu
Roland Matthews · Principal Investigator

Piedmont Healthcare

Atlanta, Georgia, 30318

Recruiting
Jean Dionne · Contact
dionne.jean@piedmont.org
Robert Klafter, MD · Principal Investigator

Hawaii Cancer Care

Honolulu, Hawaii, 96813

Recruiting
Angelei Pananganan · Contact
808-524-6115apanangan@hawaiicancercare.com
David Tamura, MD · Principal Investigator

Southern Illinois Hospital Services

Carterville, Illinois, 62918

Recruiting
Sarmad Nomani · Contact
sarmad.nomani@sih.net
Muhammad Popalzai · Principal Investigator

Cancer Care Specialists of Illinois

Decatur, Illinois, 62526

Recruiting
Jade Wiemelt · Contact
jwiemelt@ccsci.net
James Wade · Principal Investigator

Northwestern University

Evanston, Illinois, 60208

Recruiting
Mira Pasawala · Contact
mira.pasawala@northwestern.edu
Divya Gupta · Sub Investigator

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521

Recruiting
Ellen Gustafson · Contact
sgustafson@hopenheal.care
Srilata Gundala · Principal Investigator

OSF Saint Anthony Medical Center

Rockford, Illinois, 61108

Recruiting
Shylendra Sreenivasappa · Contact
815-227-2859shylendra.b.sreenivasappa2@osfhealthcare.org

Community Health Network

Indianapolis, Indiana, 46250

Recruiting
Cindy Stoner · Contact
cstoner@ecommunity.com
Natraj Ammakkanavar, MD · Principal Investigator

University of Iowa

Iowa City, Iowa, 52242

Recruiting
Laura Baptista · Contact
319-467-6412laura-batista@uiowa.edu
Muhammad Furqan · Principal Investigator

University of Maryland

Baltimore, Maryland, 21201

Recruiting
Kaylee Martin · Contact
Kaylee.Martin@umm.edu
Samuel Rosner, MD · Principal Investigator

Johns Hopkins University

Baltimore, Maryland, 21287

Recruiting
Cheryl Pai · Contact
410-614-1926cpai3@jhmi.edu
Lonny Yarmus, DO · Principal Investigator

The Center for Cancer and Blood Disorder

Bethesda, Maryland, 20817

Recruiting
Kosunique Jenkins · Contact
kosunique.jenkins@tempus.com
Mark Goldstein, MD · Principal Investigator

Frederick Health Regional System

Frederick, Maryland, 21702

Recruiting
Charity Drummond · Contact
cdrummond@frederick.health
Patrick Mansky · Principal Investigator

Mercy Clinic Oncology and Hematology - Joplin

Joplin, Missouri, 64804

Recruiting
Cynthia Meyer · Contact
Cynthia.Meyer@mercy.net
Samir Dalia, MD · Principal Investigator

Lake Regional Health System

Osage Beach, Missouri, 65065

Recruiting
Kathy Hirst · Contact
khirst@lakeregional.com
Carla Ostronic · Principal Investigator

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

Springfield, Missouri, 65804

Recruiting
Jennifer Hylton · Contact
Jennifer.Hylton@mercy.net
Mohan Tummala, MD · Principal Investigator

Oncology Hematology Associates

Springfield, Missouri, 65807

Recruiting
Adrianna Moore · Contact
417-882-4880adrianna.moore@aoncology.com
Robert Ellis, MD · Principal Investigator

Mercy Clinic Oncology and Hematology - Sindelar Cancer Center

St Louis, Missouri, 63128

Recruiting
Laura O'Brien · Contact
Laura.OBrien2@mercy.net
Yifan Tu, MD · Principal Investigator

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

St Louis, Missouri, 63141

Recruiting
Jessica Black · Contact
Jessica.Black@mercy.net
Bethany Sleckman, MD · Principal Investigator

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting
Kimberly Wendt · Contact
531-444-1230kwendt@nebraskacancer.com
Timothy Huyck, MD · Principal Investigator

OptumCare Cancer Care

Las Vegas, Nevada, 89102

Recruiting
Danielle Handy · Contact
Danielle.handy1@optum.com
Russell Gollard · Principal Investigator

Hope Cancer Care of Nevada

Las Vegas, Nevada, 89103

Recruiting
Mark Gatdula, CRC · Contact
702-508-9128Mark.Gatdula@aoncology.com
Raja Mehdi, MD · Principal Investigator

Cancer Care Specialists Reno

Reno, Nevada, 89511

Recruiting
Layla Quinonez · Contact
775-329-0222ltapia@ccsreno.com
Juan Adolfo Cattoni III · Principal Investigator

New Jersey Cancer Center

Belleville, New Jersey, 07109

Recruiting
Michael Johnstone · Contact
mjohnstone@njcancercare.com
James Orsini Jr. · Principal Investigator

New York Oncology Hematology

Albany, New York, 12206

Recruiting
Josephine Faruol · Contact
518-489-0044Josephine.faruol@usoncology.com
Makenzi Evangelist, MD · Principal Investigator

Hematology Oncology Associates of Central New York

East Syracuse, New York, 13057

Recruiting
Nicole Coleman · Contact
ncoleman@hoacny.com
Ajeet Gajra · Principal Investigator

Cayuga Medical Center

Ithaca, New York, 14850

Recruiting
Betty Haverlock · Contact
607-252-3939bhaverlock@cayugamed.org
Anthony Mato · Principal Investigator

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Recruiting
Stephanie Chang · Contact
stephanie.chang@mssm.edu
Fred Hirsch · Principal Investigator

White Plains Hospital

White Plains, New York, 10601

Recruiting
Madison Gilmore · Contact
magilmore@wphospital.org
Dan Costin · Principal Investigator

UNC

Chapel Hill, North Carolina, 27599

Recruiting
Ashley Delgado · Contact
ashley_delgado@med.unc.edu
Jason Akulian · Principal Investigator

Duke University

Durham, North Carolina, 27710

Recruiting
Lauren Gray · Contact
lauren.gray@duke.edu
Kamran Mahmood, MD · Principal Investigator

Southeastern Medical Oncology Center (SMOC)

Goldsboro, North Carolina, 27534

Recruiting
Jennifer Fields · Contact
919-587-9084jfields@cancersmoc.com
Samer Kasbari, MD · Principal Investigator

Aultman Hospital

Canton, Ohio, 44710

Recruiting
Carla Larch · Contact
(330)363-1250carla.larch@aultman.com
Raza Khan, MD · Principal Investigator

TriHealth Cancer Institute

Cincinnati, Ohio, 45220

Recruiting
Wayne Thompson · Contact
513-865-5020Wayne_Thompson@trihealth.com
Leanne Budde, MD · Principal Investigator

Ohio State University

Columbus, Ohio, 43210

Recruiting
Hazel Antao · Contact
Hazel.Antao@osumc.edu
Asrar Alahmadi · Principal Investigator

OhioHealth Reseach Institute

Columbus, Ohio, 43214

Recruiting
Kevin Miller · Contact
Kevin.Miller@ohiohealth.com
Arvinder Bhinder, MD · Principal Investigator

Taylor Cancer Research Center

Maumee, Ohio, 43537

Recruiting
Jennifer Martinez · Contact
jmartinez@toledoclinic.com
John Nemunaitis, MD · Principal Investigator

Hightower Clinical

Oklahoma City, Oklahoma, 73102

Recruiting
Caitlin Merrick · Contact
caitlin@hightowerclinical.com
Thy Nguyen, MD · Principal Investigator

Mercy Clinic Oncology and Hematology - Coletta

Oklahoma City, Oklahoma, 73120

Recruiting
Marian Nolen · Contact
Marian.Nolen@mercy.net
Carla Kurkjian, MD · Principal Investigator

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146

Recruiting
Stephanie Sandoval · Contact
918-505-3200stephanie.sandoval@ocsri.org
Paul Zito, MD · Principal Investigator

Oregon Oncology Specialists

Salem, Oregon, 97301

Recruiting
Cheryl LaBronte · Contact
clabronte@orcancer.com
Janelle Meyer, MD · Principal Investigator

Cancer Care Associates of York

York, Pennsylvania, 17403

Recruiting
Jennifer Stough · Contact
717-741-9229jstough@cancercareyork.com
Chanh Hyunh, MD · Principal Investigator

The Medical University of South Carolina

Charleston, South Carolina, 29425

Recruiting
Tyson Kelsey · Contact
tysonke@musc.edu
Christopher Gilbert, MD · Principal Investigator

Baptist Cancer Center

Memphis, Tennessee, 38120

Recruiting
Angela Gates · Contact
901-317-0644angela.gates@tempus.com
Raymond Osarogiagbon, MD · Principal Investigator

University of Virginia

Charlottesville, Virginia, 22908

Recruiting
Ryan Gentzler Principal Investigator · Contact
rg2uc@virginia.edu

PeaceHealth St. Joseph Medical Center-Bellingham

Bellingham, Washington, 98225

Recruiting
Rebecca Crompton · Contact
rcrompton@peacehealth.org
Mervat Saleh, MD · Principal Investigator

Cancer Care Northwest

Spokane Valley, Washington, 99216

Recruiting
Ronaye Wagner · Contact
ronaye.wagner@ccnw.net
Dr. Jessica Hellyer, MD · Principal Investigator

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

Recruiting
Rachel Luedtke · Contact
920-364-3616Rachel.Luedtke@thedacare.org
Matthias Weiss, MD · Principal Investigator

Gundersen Health System

La Crosse, Wisconsin, 54601

Recruiting
Jennifer Cole · Contact
608-775-6694jmcole@gundersenhealth.org
Benjamin Parsons, MD · Principal Investigator

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