GEMINI-NSCLC: NSCLC Biomarker Study

February 3, 2026 updated by: Tempus AI

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35223
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Clinic Oncology - Fort Smith
        • Contact:
        • Principal Investigator:
          • Aswanth Reddy, MD
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • MemorialCare
        • Principal Investigator:
          • Amol Rao, MD
        • Contact:
      • Los Alamitos, California, United States, 90720
        • Active, not recruiting
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Principal Investigator:
          • Amy Cummings
        • Contact:
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • Eastern CT and Hematology and Oncology Associates
        • Principal Investigator:
          • Dennis Slater
        • Contact:
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Clermont Oncology Center
        • Contact:
      • Pensacola, Florida, United States, 32503
        • Withdrawn
        • Woodlands Medical Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse School of Medicine (MSM)
        • Contact:
        • Principal Investigator:
          • Roland Matthews
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Piedmont Healthcare
        • Contact:
        • Principal Investigator:
          • Robert Klafter, MD
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Hawaii Cancer Care
        • Contact:
        • Principal Investigator:
          • David Tamura, MD
    • Illinois
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • Southern Illinois Hospital Services
        • Contact:
        • Principal Investigator:
          • Muhammad Popalzai
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois
        • Contact:
        • Principal Investigator:
          • James Wade
      • Evanston, Illinois, United States, 60208
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Hope and Healing Cancer Services
        • Principal Investigator:
          • Srilata Gundala
        • Contact:
      • Rockford, Illinois, United States, 61108
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network
        • Contact:
        • Principal Investigator:
          • Natraj Ammakkanavar, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • Muhammad Furqan
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Lonny Yarmus, DO
        • Contact:
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Samuel Rosner, MD
        • Contact:
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • The Center for Cancer and Blood Disorder
        • Principal Investigator:
          • Mark Goldstein, MD
        • Contact:
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • Frederick Health Regional System
        • Contact:
        • Principal Investigator:
          • Patrick Mansky
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Clinic Oncology and Hematology - Joplin
        • Principal Investigator:
          • Samir Dalia, MD
        • Contact:
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Health System
        • Contact:
        • Principal Investigator:
          • Carla Ostronic
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Oncology Hematology Associates
        • Contact:
        • Principal Investigator:
          • Robert Ellis, MD
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
        • Contact:
        • Principal Investigator:
          • Mohan Tummala, MD
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
        • Principal Investigator:
          • Yifan Tu, MD
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
        • Contact:
        • Principal Investigator:
          • Bethany Sleckman, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Timothy Huyck, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • Recruiting
        • Hope Cancer Care of Nevada
        • Contact:
        • Principal Investigator:
          • Raja Mehdi, MD
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care
        • Contact:
        • Principal Investigator:
          • Russell Gollard
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Cancer Care Specialists Reno
        • Contact:
        • Principal Investigator:
          • Juan Adolfo Cattoni III
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Recruiting
        • New Jersey Cancer Center
        • Contact:
        • Principal Investigator:
          • James Orsini Jr.
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • New York Oncology Hematology
        • Principal Investigator:
          • Makenzi Evangelist, MD
        • Contact:
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Hematology Oncology Associates of Central New York
        • Contact:
        • Principal Investigator:
          • Ajeet Gajra
      • Ithaca, New York, United States, 14850
        • Recruiting
        • Cayuga Medical Center
        • Principal Investigator:
          • Anthony Mato
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Fred Hirsch
      • White Plains, New York, United States, 10601
        • Recruiting
        • White Plains Hospital
        • Principal Investigator:
          • Dan Costin
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Kamran Mahmood, MD
        • Contact:
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center (SMOC)
        • Contact:
        • Principal Investigator:
          • Samer Kasbari, MD
    • Ohio
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Hospital
        • Principal Investigator:
          • Raza Khan, MD
        • Contact:
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Cancer Institute
        • Contact:
        • Principal Investigator:
          • Leanne Budde, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • Asrar Alahmadi
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Reseach Institute
        • Principal Investigator:
          • Arvinder Bhinder, MD
        • Contact:
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Taylor Cancer Research Center
        • Principal Investigator:
          • John Nemunaitis, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Clinic Oncology and Hematology - Coletta
        • Principal Investigator:
          • Carla Kurkjian, MD
        • Contact:
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute
        • Principal Investigator:
          • Paul Zito, MD
        • Contact:
    • Oregon
      • Salem, Oregon, United States, 97301
        • Recruiting
        • Oregon Oncology Specialists
        • Principal Investigator:
          • Janelle Meyer, MD
        • Contact:
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates of York
        • Contact:
        • Principal Investigator:
          • Chanh Hyunh, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • The Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Christopher Gilbert, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Cancer Center
        • Principal Investigator:
          • Raymond Osarogiagbon, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
    • Washington
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth St. Joseph Medical Center-Bellingham
        • Contact:
        • Principal Investigator:
          • Mervat Saleh, MD
      • Spokane Valley, Washington, United States, 99216
        • Recruiting
        • Cancer Care Northwest
        • Contact:
        • Principal Investigator:
          • Dr. Jessica Hellyer, MD
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthias Weiss, MD
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Health System
        • Contact:
        • Principal Investigator:
          • Benjamin Parsons, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This protocol targets patients with Non-Small Cell Lung Cancer (NSCLC)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Observation
No intervention
Cohort 2
Cohort 2 will include patients with stage IV disease receiving first line immunotherapy (as monotherapy or in combination with chemotherapy).
Other: Observation
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Real-World Disease Free Survival (rwDFS)
Time Frame: 5 years
5 years
Real-World Overall Survival (rwOS)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
5 years
Real-World Disease Free Survival (rwDFS) stratified by ctDNA status at benchmark
Time Frame: 5 years
5 years
pCR rate stratified by ctDNA status
Time Frame: 5 years
5 years
Real-World Overall Survival (rwOS) stratified by ctDNA status at benchmark
Time Frame: 5 years
5 years
Positive percent agreement and negative percent agreement between plasma ctDNA vs tumor tissue at benchmark & longitudinal time points
Time Frame: 5 years
5 years
Real-World Overall Survival
Time Frame: 18 months
18 months
Real-World Progression-Free
Time Frame: 18 months
18 months
Treatment patterns
Time Frame: 18 months
18 months
Positive percent agreement and negative percent agreement between plasma ctDNA vs. tumor tissue at benchmark & longitudinal time points
Time Frame: 18 months
18 months

Other Outcome Measures

Outcome Measure
Time Frame
Prevalence of genomic variants at landmark timepoints
Time Frame: 5 years
5 years
Compare ctDNA levels detected before and after biopsy
Time Frame: 5 years
5 years
Prevalence of genomic variants at landmark timepoints
Time Frame: 18 months
18 months
Identification of the emergence of genomic variants and tumor biologic subclones over time with early-stage and advanced stage lung cancer
Time Frame: 5 years
5 years
Identify genomic determinants of disease recurrence or progression.
Time Frame: 5 years
5 years
Define ctDNA status at clinically-meaningful timeframes: at completion of neoadjuvant therapy, at the completion of surgery, at the completion of adjuvant therapy, and 30 days post completion of all therapy.
Time Frame: 5 years
5 years
Correlate ctDNA clearance with the ability to obtain pCR
Time Frame: 5 years
5 years
Correlate ctDNA detection rate with stage of disease (stages I - III)
Time Frame: 5 years
5 years
Define ctDNA dynamics at specified surveillance timepoints and correlate with simultaneous imaging and clinical disease status
Time Frame: 5 years
5 years
Define PPV of ctDNA to predict recurrence
Time Frame: 5 years
5 years
Correlate ctDNA clearance (or lack of clearance) with rwPFS and rwOS.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tempus AI

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Virginia Rhodes, MD, Tempus AI, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-CA-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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